Author Affiliations

1. Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, United States
2. Health Economics and Outcomes Research, Optum, Eden Prairie, Minnesota, United States
3. Value Demonstration Team, Boehringer Ingelheim, Ridgefield, Connecticut, United States

Address correspondence to:

Swetha R. Palli, MS
E-mail: swetha.palli@boehringer-ingelheim.com
Phone: (203)798-4460

Abstract

Background: Triple therapy (long-acting muscarinic antagonist [LAMA] plus long-acting beta2-agonist [LABA] plus inhaled corticosteroid [ICS]) is recommended by the Global initiative for chronic Obstructive Lung Disease (GOLD) for moderate-to-severe chronic obstructive pulmonary disease (COPD) with a history of frequent and/or severe exacerbation(s) and dyspnea while using dual bronchodilators. However, many patients receive triple therapy contrary to these recommendations. This study describes factors associated with GOLD-discordant triple therapy initiation.

Methods: This retrospective analysis included patients aged 40 and above, with ≥1 COPD diagnosis, who initiated triple therapy (initiation=index date) during the period January 1, 2014 to December 31, 2018 and had ≥12 months pre-index continuous enrollment (baseline). Triple therapy comprised ≥30 days of overlapping LAMA, LABA, and ICS treatments (open triple therapy), or single-inhaler fluticasone furoate/umeclidinium/vilanterol (closed triple therapy). Cohorts were defined based on the absence of baseline maintenance medication use (“maintenance-naïve”), and/or exacerbations (“exacerbation-discordant”), or “dual-discordant” (discordant on both measures). All triple therapy initiators, overall and for each cohort, were described, and predictors of GOLD-discordant triple therapy initiation were identified.

Results: Among 21,711 triple therapy initiators, 34.4% were maintenance-naïve, 61.9% exacerbation-discordant, and 22.2% dual-discordant. Triple therapy initiation appeared to increase during the period 2016 to 2018. In 2018 alone, 31.9% and 58.3% of open triple therapy patients were maintenance-naïve and exacerbation-discordant, respectively, versus 37.6% and 64.4% of closed triple therapy patients. Closed triple therapy initiators had 1.65 times greater risk of dual discordance than open triple therapy initiators. Exacerbation-discordant patients initiating closed triple therapy were 1.61 times more likely to be maintenance-naïve than those initiating open triple therapy.

Conclusion: A substantial proportion of COPD patients initiating triple therapy do not meet GOLD recommendations regarding exacerbation history and/or prior maintenance therapy. Compared with open triple therapy, closed triple therapy initiators were more likely to be dual discordant.

Citation

Citation: Bhatt SP, Blauer-Peterson C, Buysman EK, Bengston LGS, Palli SR. Trends and characteristics of Global Initiative for Chronic Obstructive Lung Disease guidelines-discordant prescribing of triple therapy among patients with COPD. J COPD F. 2022; 9(2): 135-153. doi: http://doi.org/10.15326/jcopdf.9.2.2021.0256

Keywords

chronic obstructive pulmonary disease, GOLD, triple therapy, long-acting corticosteroid, bronchodilators

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Click to read Trends and Characteristics of Global Initiative for Chronic Obstructive Lung Disease Guidelines-Discordant Prescribing of Triple Therapy Among Patients with COPD

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Author Affiliations

1. Department of Anesthesiology and Perioperative Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, China
2. Division of Chest, Department of Internal Medicine, Lo-Hsu Medical Foundation, Lotung Poh-Ai Hospital, Yilan, Taiwan
3. Department of Food Nutrition and Health Biotechnology, College of Medical and Health Science, Asia University, Taichung, Taiwan
4. Big Data Center, Lo-Hsu Medical Foundation, Lotung Poh-Ai Hospital, Yilan, Taiwan
5. Division of Radiation Oncology, Lo-Hsu Medical Foundation, Lotung Poh-Ai Hospital, Yilan, Taiwan
6. Department of Healthcare Administration, College of Medical and Health Science, Asia University, Taichung, Taiwan
7. Cancer Center, Lo-Hsu Medical Foundation, Lotung Poh-Ai Hospital, Yilan, Taiwan
8. Graduate Institute of Business Administration, Fu Jen Catholic University, Taipei, Taiwan
9. Centers for Regional Anesthesia and Pain Medicine, Taipei Municipal Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan

Address correspondence to:

Szu-Yuan Wu, MD, MPH, PhD & Kuo-Chin Chiu, MD
No. 83, Nanchang St.
Luodong Township
Yilan County 265, Taiwan
Email: szuyuanwu5399@gmail.com

Abstract

Background: The survival effect of smoking-related chronic obstructive pulmonary disease (COPD) and COPD with acute exacerbation (COPDAE) before surgery on patients with oral cavity squamous cell carcinoma (OCSCC) is unclear.

Methods: Using the Taiwan Cancer Registry Database, we enrolled patients with OCSCC (pathologic stages I–IVB) receiving surgery. The Cox proportional hazards model was used to analyze all-cause mortality. We categorized the patients into 2 groups by using propensity score matching based on the pre-existing COPD status (≤1 year before surgery) to compare overall survival outcomes: Group 1 (never smokers without COPD) and Group 2 (current smokers with COPD).

Results: In multivariate Cox regression analyses, the adjusted hazard ratio (aHR; 95% confidence interval [CI]) of all-cause mortality in Group 2 compared with Group 1 was 1.07 (1.02–1.16, P = 0.041). The aHR (95% CIs) of all-cause mortality for ≥1 hospitalizations for COPDAE within 1 year before surgery for patients with OCSCC was 1.31 (1.02–1.64; P = 0.011) compared with no COPDAE in patients with OCSCC receiving surgery. Among patients with OCSCC undergoing curative surgery, current smokers with smoking-related COPD demonstrated poorer survival outcomes than did nonsmokers without COPD, for both OCSCC death and all-cause mortality. Hospitalization for COPDAE within 1 year before surgery was found to be an independent risk factor for overall survival in these patients with OCSCC.

Conclusion: Prevention of COPD progression to COPDAE may lead to an increase in overall survival in patients with OCSCC receiving curative surgery.

Citation

Citation: Zhang J, Lin W-C, Chiu K-C, Wu S-Y. Current smoking-related COPD or COPD with acute exacerbation is associated with poorer survival following oral cavity squamous cell carcinoma surgery. J COPD F. 2022; 9(2): 181-194. doi: http://doi.org/10.15326/jcopdf.9.2.2022.0286

Keywords

COPD, cigarette smoking, oral cavity squamous cell carcinomas, acute exacerbation, survival

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Click to read Current-Smoking-Related COPD or COPD With Acute Exacerbation is Associated With Poorer Survival Following Oral Cavity Squamous Cell Carcinoma Surgery

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Author Affiliations

1. Rehabilitation Clinical Trials Center, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, United States
2. COPD Foundation, Washington, DC, United States
3. Evidera, Bethesda, Maryland, United States
4. Medical Department, Boehringer Ingelheim, Burlington, Ontario, Canada

Address correspondence to:

Richard Casaburi, PhD, MD
Rehabilitation Clinical Trials Center
The Lundquist Institute at Harbor UCLA Medical Center, CDCRC Building
Torrance, CA 90502
Email: casaburi@ucla.edu
Phone: (424) 201-3000 x7269

Abstract

The Chronic Lung Disease Biomarker and Clinical Outcome Assessment Qualification Consortium (CBQC) evaluates the potential of biomarkers and outcome measures as drug development tools. Exercise endurance is an objective indicator of treatment benefit, closely related to daily physical function. Therefore, it is an ideal candidate for an outcome for drug development trials. Unfortunately, no exercise endurance measure is qualified by regulatory authorities for use in trials of chronic obstructive pulmonary disease (COPD) and no approved COPD therapies have claims of improving exercise endurance. Consequently, it has been challenging for developers to consider this outcome when designing clinical trials for new therapies.

Endurance time during constant work rate cycle ergometry (CWRCE), performed on an electronically braked stationary cycle ergometer, provides an exercise endurance measure under standardized conditions. Baseline individualized work rate for each participant is set using an incremental test. During CWRCE the patient is encouraged to continue exercising for as long as possible. Although not required, physiological and sensory responses (e.g., pulmonary ventilation, heart rate, dyspnea ratings) are frequently collected to support interpretation of endurance time changes. Exercise tolerance limit is reached when the individual is limited by symptoms, unable to maintain pedaling cadence or unable to continue safely. At exercise cessation, exercise duration is recorded.

An CWRCE endurance time increase from the pre-treatment baseline is proposed as a key efficacy endpoint in clinical trials. In COPD, improved exercise endurance has a direct relationship to the experience of physical functioning in daily life, which is a patient-centered, meaningful benefit.

Citation

Citation: Casaburi R, Merrill DD, Harding G, et al. A conceptual framework for use of increased endurance time during constant work rate cycle ergometry as a patient-focused meaningful outcome in COPD clinical trials. J COPD F. 2022; 9(2): 252-265. doi: http://doi.org/10.15326/jcopdf.9.2.2021.0258

Keywords

COPD, exercise endurance, physical functioning, clinical outcome assessment, drug development

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Click to read A Conceptual Framework for Use of Increased Endurance Time During Constant Work Rate Cycle Ergometry as a Patient-Focused Meaningful Outcome in COPD Clinical Trials

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Author Affiliations

1. Pulmonary, Critical Care and Sleep Medicine Section, College of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
2. General Internal Medicine, College of Medicine, and Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
3. Biostatistics and Epidemiology, College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
4. College of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Address correspondence to:

Huimin Wu, MD, MPH
Phone: 405-271-6173
Email: Huimin-Wu@ouhsc.edu

Abstract

Background: The prevalence of chronic obstructive pulmonary disease (COPD) is high in American Indian (AI) populations, as are diabetes and obesity, which are common COPD comorbidities. However, COPD research among AI populations is limited.

Study Design and Methods: We conducted a retrospective study to investigate potential health disparities and risk factors among AI and non-Hispanic White (NHW) patients with COPD exacerbations hospitalized at the University of Oklahoma Medical Center between July 2001 and June 2020. Demographics, clinical variables, and outcomes were collected.

Results: A total of 76 AI patients and 304 NHW patients were included. AI patients had more comorbidities than did NHW patients (4.3 versus.3.1, p<0.001). In multiple variable analyses, AI race was associated with higher odds of needing intensive care unit (ICU) care ( odds ratio [OR], 2.37, 95% confidence interval [CI], 1.36­–4.16, p=0.002) and invasive mechanical ventilator use (OR, 2.75, 95% CI, 1.42–5.29, p=0.002). AI race was also associated with longer ICU stays compared with NHWs (OR, 1.43, 95% CI, 1.18­–1.73, p<0.001). The average number of days on mechanical ventilator support increased by 137.3% for an AI patient compared to an NHW patient (p<0.001). AI race was not associated with discharge to other health facilities (OR, 0.98, 95% CI, 0.52–1.83, p=0.944).

Interpretation: AI patients were more likely than NHW patients to need ICU care and ventilator support, have longer ICU stays, and more days on mechanical ventilator support. More studies are needed to identify reasons for these disparities and effective interventions to reduce them.

Citation

Citation: Wu H, Rhoades DA, Chen S, et al. Disparities in hospitalized chronic obstructive pulmonary disease exacerbations between American Indians and non-Hispanic Whites. J COPD F. 2022; 9(2): 122-134. doi: http://doi.org/10.15326/jcopdf.9.2.2021.0246

Keywords

chronic obstructive pulmonary disease, American Indian, health disparities, non-Hispanic White

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Click to read Disparities in Hospitalized Chronic Obstructive Pulmonary Disease Exacerbations Between American Indians and Non-Hispanic Whites

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Author Affiliations

1. Department of Radiology, University of Iowa, Iowa City, Iowa, United States
2. Department of Biomedical Engineering, University of Iowa, Iowa City, Iowa, United States
3. Holden Comprehensive Cancer Center, University of Iowa, Iowa City, Iowa, United States
4. Department of Public Health Sciences, Henry Ford Health System, Detroit, Michigan, United States
5. Henry Ford Cancer Institute, Henry Ford Health System, Detroit, Michigan, United States
6. Karmanos Cancer Institute, Wayne State University, Detroit, Michigan, United States

Address correspondence to:

Jessica C. Sieren, PhD
University of Iowa
Department of Radiology
200 Hawkins Drive, CC704GH
Iowa City, IA 52242
Phone: (319) 356-1407
Email: Jessica-sieren@uiowa.edu

Abstract

Background: Chronic obstructive pulmonary disease (COPD) is a known comorbidity for lung cancer independent of smoking history. Quantitative computed tomography (qCT) imaging features related to COPD have shown promise in the assessment of lung cancer risk. We hypothesize that qCT features from the lung, lobe, and airway tree related to the location of the pulmonary nodule can be used to provide informative malignancy risk assessment.

Methods: A total of 183 qCT features were extracted from 278 individuals with a solitary pulmonary nodule of known diagnosis (71 malignant, 207 benign). These included histogram and airway characteristics of the lungs, lobe, and segmental paths. Performances of the least absolute shrinkage and selection operator (LASSO) regression analysis and an ensemble of neural networks (ENN) were compared for feature set selection and classification on a testing cohort of 49 additional individuals (15 malignant, 34 benign).

Results: The LASSO and ENN methods produced different feature sets for classification with LASSO selecting fewer qCT features (7) than the ENN (17). The LASSO model with the highest performing training area under the curve (AUC) (0.80) incorporated automatically extracted features and reader-measured nodule diameter with a testing AUC of 0.62. The ENN model with the highest performing AUC (0.77) also incorporated qCT and reader diameter but maintained higher testing performance AUC (0.79).

Conclusions: Automatically extracted qCT imaging features of the lung can be informative of the differentiation between individuals with malignant pulmonary nodules and those with benign pulmonary nodules, without requiring nodule segmentation and analysis.

Citation

Citation: Uthoff JM, Mott SL, Larson J, et al; the COPDGene Investigators. Computed tomography features of lung structure have utility for differentiating malignant and benign pulmonary nodules. J COPD F. 2022; 9(2): 154-164. doi: http://doi.org/10.15326/jcopdf.9.2.2021.0271

Keywords

chronic obstructive pulmonary disease, quantitative computed tomography, cancer risk assessment, machine learning, artificial intelligence

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Click to read Computed Tomography Features of Lung Structure Have Utility for Differentiating Malignant and Benign Pulmonary Nodules

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Author Affiliations

1. Lung Health Center, Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, University of Alabama, Birmingham, Alabama, United States
2. Denver, Colorado

Address correspondence to:

Takudzwa Mkorombindo, MD
Email: tmkorombindo@uabmc.edu

Abstract

This article does not contain an abstract.

Citation

Citation: Mkorombindo T, Balkisson R. Journal club: respiratory impairment with a preserved spirometric ratio. J COPD F. 2022; 9(1): 103-110. doi: http://doi.org/10.15326/jcopdf.9.1.2022.0285

Keywords

PRISm, preserved ratio-impaired spirometry, pre-COPD

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Click to read Journal Club-Respiratory Impairment With A Preserved Spirometric Ratio

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Author Affiliations

1. Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania, United States.

Address correspondence to:

Gerard J. Criner, MD
Department of Thoracic Medicine and Surgery
Lewis Katz School of Medicine
Temple University
745 Parkinson Pavilion
3401 North Broad Street
Philadelphia, PA 19140
Phone: (215) 707-8113
Email: gerard.criner@tuhs.temple.edu

Abstract

Rationale: High-flow nasal therapy (HFNT) has beneficial effects in patients hospitalized with acute hypoxemic respiratory failure. HFNT has not been extensively studied following hospitalization for an acute exacerbation of chronic obstructive pulmonary disease (AECOPD).

Objective: We explored the feasibility of conducting a multicentered trial to evaluate the use of HFNT to increase the time to next moderate/ severe exacerbation in patients recently hospitalized for a COPD exacerbation. In this pilot study we measured the hours of home daily HFNT use, maximally tolerated flow rates and temperature, and side effects for a period of 90 days.

Methods: Patients were enrolled in a 90-day, open-labeled pilot study of HFNT to determine the safety and feasibility of home use for daily outpatient COPD management. Patients ≥ 40 years of age with prior hospitalization within the past 12 weeks for an AECOPD were enrolled. COPD was the primary diagnosis in all patients.

Results: Thirty patients presented for HFNT titration. Two dropped out; 1 after receiving a lung transplant and the other was lost to follow-up. The remaining 28 patients completed 90 days of HFNT. None withdrew from HFNT due to intolerance. Use of HFNT averaged 6.8 (2.1) hours daily.

Conclusions: Daily home HFNT for up to 3 months is feasible in COPD patients following hospitalization for AECOPD. Improvements observed in disease-specific quality of life, respiratory symptoms, and 6-minute walk distance suggest the need for a prospective multicenter controlled clinical trial.

Citation

Citation: Criner GJ, Criner L-YH, George SA, Thomas JK, Jacobs MR. Feasibility of using daily home high-flow nasal therapy in COPD patients following a recent COPD hospitalization. J COPD F. 2022; 9(1): 4-14. doi: http://doi.org/10.15326/jcopdf.9.1.2021.0236

Keywords

COPD, acute exacerbation of COPD, high-flow nasal therapy, home care

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Click to read Feasibility of Using Daily Home High-Flow Nasal Therapy in COPD Patients Following a Recent COPD Hospitalization

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Author Affiliations

1. TechSpring, Baystate Health, Springfield, Massachusetts, United States
2. Institute for Healthcare Delivery and Population Science, University of Massachusetts Chan Medical School – Baystate, Springfield, Massachusetts, United States
3. Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, United States
4. College of Professional Studies, Respiratory Care Leadership, Northeastern University, Boston Massachusetts, United States
5. Department of Respiratory Care, Massachusetts General Hospital, Boston, Massachusetts, United States
6. Department of Medicine, University of Massachusetts Chan Medical School - Baystate, Springfield, Massachusetts, United States
7. Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, Massachusetts, United States
8. Division of Pulmonary and Critical Care Medicine, Tufts University School of Medicine, Boston, Massachusetts, United States
9. Division of Pulmonary and Critical Care, Department of Medicine, University of Massachusetts Chan Medical School - Baystate, Springfield, Massachusetts, United States
10. College of Applied Health Science at the University of Illinois at Chicago, Chicago, Illinois, United States

Address correspondence to:

Mihaela S. Stefan, MD, PhD
Associate Professor of Medicine, Hospitalist, and Clinician Investigator
Institute for Healthcare Delivery and Population Science
University of Massachusetts Chan Medical School- Baystate
Springfield, MA
Phone: (413) 794-0000
Email: Mihaela.Stefan@baystatehealth.org

Abstract

Background: This study brings a human-centered design (HCD) perspective to understanding the patient experience when using noninvasive ventilation (NIV) with the goal of creating better strategies to improve NIV comfort and tolerance.

Methods: Using an HCD motivational approach, we created a semi-structured interview to uncover the patients’ journey while being treated with NIV. We interviewed 16 patients with chronic obstructive pulmonary disease (COPD) treated with NIV while hospitalized. Patients’ experiences were captured in a stepwise narrative creating a journey map as a framework describing the overall experience and highlighting the key processes, tensions, and flows. We broke the journey into phases, steps, emotions, and themes to get a clear picture of the overall experience levers for patients.

Results: The following themes promoted NIV tolerance: trust in the providers, the favorable impression of the facility and staff, understanding why the mask was needed, how NIV works and how long it will be needed, immediate relief of the threatening suffocating sensation, familiarity with similar treatments, use of meditation and mindfulness, and the realization that treatment was useful. The following themes deterred NIV tolerance: physical and psychological discomfort with the mask, impaired control, feeling of loss of control, and being misinformed.

Conclusions: Understanding the reality of patients with COPD treated with NIV will help refine strategies that can improve their experience and tolerance with NIV. Future research should test ideas with the best potential and generate prototypes and design iterations to be tested with patients.

Citation

Citation: McCormick JL, Clark TA, Shea CM, et al. Exploring the patient experience with noninvasive ventilation: a human-centered design analysis to inform planning for better tolerance. J COPD F. 2022; 9(1): 80-94. doi: http://doi.org/10.15326/jcopdf.9.1.2021.0274

Keywords

COPD, noninvasive ventilation, patient experience, human-centered design, qualitative analysis

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Click to read Exploring the Patient Experience with Noninvasive Ventilation: A Human-Centered Design Analysis to Inform Planning for Better Tolerance

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Author Affiliations

1. Division of Pulmonary, Allergy, and Critical Care, Columbia University Medical Center, New York, New York, United States
2. University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, United States
3. GlaxoSmithKline, Research Triangle Park, North Carolina, United States
4. Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, United States
5. Lung Health Center, Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, United States
6. University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, United Kingdom
7. Pulmonary and Critical Care, University of Michigan, Ann Arbor, Michigan, United States
8. Section of Epidemiology, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
9. Medical Department, Copenhagen University Hospital - Herlev and Gentofte, Herlev, Denmark
10. Weill Cornell Medicine, New York, New York, United States
11. GlaxoSmithKline, Brentford, Middlesex, United Kingdom
12. Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester University NHS Foundation Trust, Manchester, United Kingdom
13. Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
14. GlaxoSmithKline, Collegeville, Pennsylvania, United States
15. Pulmonary, Allergy, and Critical Care Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, United States

^*Affiliation at the time of the study.

Address correspondence to:

Byron Thomashow, MD
Division of Pulmonary, Allergy, and Critical Care
Columbia University Medical Center
161 Fort Washington Ave.
New York, NY 10032
Phone: (212) 305-5261
Email: bmt1@cumc.columbia.edu

Abstract

Background: In the InforMing the PAthway of COPD Treatment (IMPACT) trial, single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) reduced moderate/severe exacerbation rates versus FF/VI and UMEC/VI in patients with chronic obstructive pulmonary disease (COPD). This post hoc analysis tested the relationship between baseline health status, risk of future exacerbations, and efficacy outcomes.

Methods: IMPACT was a Phase 3, double-blind, 52-week trial in patients with symptomatic COPD (COPD Assessment Test [CAT] score ≥10) and ≥1 moderate/severe exacerbation in the prior year randomized 2:2:1 to FF/UMEC/VI 100/62.5/25mcg, FF/VI 100/25mcg, or UMEC/VI 62.5/25mcg. Annual rate of on-treatment moderate/severe exacerbations, lung function, and safety were analyzed by continuous baseline CAT score.

Results: Moderate/severe exacerbation rates increased with increasing baseline CAT scores in FF/UMEC/VI and UMEC/VI arms. There was a very small increase in on-treatment pneumonia rates at higher baseline CAT scores across all treatment arms. FF/UMEC/VI reduced moderate/severe exacerbation rates versus UMEC/VI (i.e., the inhaled corticosteroid effect) consistently across the range of CAT scores. The reduction with FF/UMEC/VI versus FF/VI (i.e., the long-acting muscarinic antagonist effect) was greatest at lower CAT scores and appeared lesser at higher CAT scores. Improvements in lung function were observed with FF/UMEC/VI versus FF/VI and UMEC/VI, regardless of baseline CAT score.

Conclusion: The CAT score was predictive of exacerbation risk. Worse baseline health status was associated with higher moderate/severe exacerbation and pneumonia rates. Irrespective of baseline CAT score, FF/UMEC/VI improved lung function, and reduced the annual moderate/severe exacerbation rates versus dual therapy. Results indicate an overall favorable benefit-risk profile of triple versus dual therapy, irrespective of CAT score.

Clinical Trial Registration:GSK (CTT116855/NCT02164513).

Citation

Citation: Thomashow B, Stiegler M, Criner GJ, et al. Higher COPD Assessment Test score associated with greater exacerbations risk: a post hoc analysis of the IMPACT trial. J COPD F. 2022; 9(1): 68-79. doi: http://doi.org/10.15326/jcopdf.9.1.2021.0259

Keywords

exacerbations, COPD Assessment Test, patient-reported outcomes, single-inhaler triple therapy, IMPACT trial

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Click to read Higher COPD Assessment Test Score Associated With Greater Exacerbations Risk: A Post Hoc Analysis of the IMPACT Trial

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Author Affiliations

1. Graduate School of Biomedical Sciences, School of Graduate Medical Education, Mayo Clinic, Rochester, Minnesota, United States
2. Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, United States
3. Mindful Breathing Laboratory, Department of Pulmonology and Critical Care Medicine, Mayo Clinic, Rochester, Minnesota, United States

Address correspondence to:

Roberto P. Benzo, MD
200 First St. S.W.
Rochester, MN 55905
Phone: 507-284-0561
Email:benzo.roberto@mayo.edu

Abstract

Introduction: There is a knowledge gap about how much physical activity is recommended to patients with chronic obstructive pulmonary disease (COPD). We asked, what is the average difference in sedentary time and physical activity associated with clinically meaningful differences in symptoms in a large, well-characterized cohort of patients with advanced COPD?

Study Design and Methods: We conducted a cross-sectional analysis of daily activity data in 292 patients with stable COPD. Activity measure coefficients from multivariable linear models were used to predict the average difference in activity between patients with twice the minimal clinically important difference in reported symptoms.

Results: Symptoms were assessed with the Chronic Respiratory Disease Questionnaire subdomains – dyspnea, fatigue, mastery, and emotions. Daily steps, minutes in light physical activity, and sedentary time were measured by triaxial accelerometers. Average sedentary time, light physical activity, and steps were 767.6 minutes, 177.7 minutes, and 2960 steps, respectively. Individuals with 1-point better dyspnea scores averaged 24.5 (8.4–40.5) minutes less sedentary time per day. Individuals with 1-point better dyspnea and fatigue scores averaged 21.5 (10.9–32.3) minutes or 12.5 (2.0–23.2) minutes more light physical activity per day, respectively. Individuals with 1-point better dyspnea, fatigue, mastery, and emotions scores averaged 762 (546–984), 579 (351–814), 418 (207–636), and 392 (157–634) more steps per day, respectively.

Conclusions: We provide guidance to clinicians counseling patients with severe COPD in activity-related goal setting on sedentary time, light physical activity, and steps associated with better symptoms.

Citation

Citation: Driver CN, Novotny PJ, Benzo RP. Differences in sedentary time, light physical activity, and steps associated with better COPD quality of life. J COPD F. 2022; 9(1): 34-44. doi: http://doi.org/10.15326/jcopdf.9.1.2021.0230

Keywords

accelerometer, Chronic Respiratory Disease Questionnaire, behavioral interventions

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Click to read Differences in Sedentary Time, Light Physical Activity, and Steps Associated with Better COPD Quality of Life

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Author Affiliations

1. COPD Foundation, Miami, Florida, United States
2. University of Kentucky, Lexington, Kentucky, United States
3. University of California San Diego, La Jolla, California, United States

* Affiliation at the time the study was conducted.

Address correspondence to:

Carl Stepnowsky, PhD
3350 La Jolla Village Drive (111n-1)
San Diego, CA 92161
Phone: 858-642-1240
Email: cstepnowsky@health.ucsd.edu

Abstract

Introduction: Few studies have asked chronic obstructive pulmonary disease (COPD) -obstructive sleep apnea (OSA) overlap syndrome patients what outcomes of continuous positive airway pressure (CPAP) therapy are important to them, while also considering their self-reported CPAP adherence barriers and facilitators. This study conducted a series of focus groups to learn about those issues with the goal of applying these findings to the design of a larger Patient-Centered Outcomes Research Institute-funded scientific study, the O₂VERLAP Study.

Methods: People previously diagnosed with both COPD and OSA, who were current or recent past users of the standard therapy for each condition (i.e., supplemental oxygen and CPAP, respectively), were included. Three qualitative focus groups were run using different communication modalities: (1) teleconference (audio only), (2) in-person, and (3) web-based.

Results: The focus groups included a total of 17 participants. The telephone and online focus groups resulted in more relevant and content-rich transcripts, while the in-person focus groups had far fewer excerpts able to be coded. Participants were most concerned about mask fit and comfort. Other key factors affecting CPAP use included nasal dryness and issues concerning insurance. The most important outcome to patients was daytime functioning.

Discussion: This work found that telephone and web-based qualitative focus groups resulted in greater topical discussions than in-person focus groups, likely due to the customary socializing that occurs in-person. The study identified: (1) CPAP use barriers and facilitators that helped guide intervention development for the larger study and, (2) daytime functioning as the most important outcome for patients.

Citation

Citation: Sullivan J, Pasquale C, Clark B, et al. Outcomes important to patients diagnosed with both COPD and sleep apnea: findings from the O₂VERLAP study focus groups. J COPD F. 2022; 9(1): 45-54. doi: http://doi.org/10.15326/jcopdf.9.1.2021.0268

Keywords

chronic obstructive pulmonary disease, qualitative research, obstructive sleep apnea

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Click to read Outcomes Important to Patients Diagnosed with Both COPD and Sleep Apnea: Findings from the O₂VERLAP Study Focus Groups

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Author Affiliations

1. Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, Washington, United States
2. Department of Medicine, University of Washington, Seattle, Washington, United States
3. Health Services Research and Development Center of Innovation for Veteran-Centered and Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States
4. Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington, United States

Address correspondence to:

Thomas Keller, MD, MS
Division of Pulmonary,
Critical Care, and Sleep Medicine
Department of Medicine
University of Washington
Campus Box 356522
Seattle, WA 98195-6522
Phone: 206-543-3166
Email: tlk33@uw.edu

Abstract

Rationale: Large gaps exist between guideline-recommended outpatient chronic obstructive pulmonary disease (COPD) care and clinical practice. Seeking to design effective interventions, we identified patient and primary care provider (PCP) characteristics associated with receiving evidence-based COPD care.

Methods: We performed an observational study of adults aged ≥ 40 years with clinically diagnosed COPD who received care at 2 University of Washington-affiliated primary care clinics between June 1, 2011, and June 1, 2013. Our primary outcome was the proportion of evidence-based outpatient COPD quality measures received through primary or pulmonary care. Among all patients, we assessed spirometry completion, respiratory symptom identification, smoking status ascertainment, oxygen saturation measurement, and guideline-concordant inhaled therapy prescription. We also determined confirmation of airflow obstruction, oxygen prescription, smoking cessation intervention, and pulmonary rehabilitation referral if eligible. We used multivariable mixed effects linear regression to estimate the association of patient and PCP characteristics with the primary outcome.

Results: Among 641 patients, 382 were male (59.6%) with mean age 63.6 (standard deviation [SD] 10.6) years. Most patients currently smoked (N=386, 60.2%). Patients saw 150 unique PCPs during 5.3 (SD 3.2) PCP visits, with 107 completing pulmonary referrals (16.7%). Patients received 67.5% (SD 18.4%) of eligible (median 7 [interquartile range 6–7]) evidence-based quality measures. After adjustment, pulmonary referral was associated with a higher receipt of outpatient quality measures (ß₁17.7%, 95% confidence interval: 12.6%, 22.7%). Patient demographics, comorbidities, and PCP identity/characteristics were not associated with outpatient care quality.

Conclusions: The quality of outpatient COPD care was suboptimal. Future studies should investigate if engaging pulmonologists in COPD management improves care quality.

Citation

Citation: Keller TL, Wright J, Donovan LM, et al. Association of patient and primary care provider factors with outpatient COPD care quality. J COPD F. 2022; 9(1): 55-67. doi: http://doi.org/10.15326/jcopdf.9.1.2021.0232

Keywords

chronic obstructive pulmonary disease, spirometry, quality of health care, bronchodilator agents

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Click to read Association of Patient and Primary Care Provider Factors with Outpatient COPD Care Quality

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Author Affiliations

1. Department of Pharmacy, Cleveland Clinic, Cleveland, Ohio, United States
2. Division of Pulmonary and Critical Care Medicine, Medical University of South Carolina, Charleston, South Carolina, United States
3. Division of Pulmonary, Critical Care and Sleep Medicine, University of Florida, Gainesville, Florida, United States
4. Education and Respiratory Institute, Cleveland Clinic, Cleveland, Ohio, United States

Address correspondence to:

James K. Stoller, MD, MS
Education Institute
Cleveland Clinic
9500 Euclid Ave. NA 22
Cleveland, OH 44195
Phone:(216) 444-1960
Email:stollej@ccf.org

Abstract

Background: Alpha-1 antitrypsin deficiency (AATD) is under-recognized, prompting the need for enhanced detection strategies. The primary aim of this study is to determine the feasibility of using the electronic medical record (EMR) and linked electronic patient messages (EPM) to encourage AATD testing by patients with chronic obstructive pulmonary disease (COPD).

Methods: Study participants were eligible, untested adult patients who were prescribed an inhaled medication which is exclusively Food and Drug Administration-approved for treating COPD. Eligible patients received a message with basic information about AATD and availability of free, home-based AATD testing. Through a collaboration with the Alpha-1 Foundation’s Alpha-1 Coded Testing (ACT) study, patients referred to home-based testing through EPM were flagged. The effectiveness of the electronic message was evaluated by the proportion of patients who underwent testing, and the rate of detecting individuals with severe deficiency of AAT among those tested.

Results: A total of 12,369 patients on eligible inhalers were screened; 5430 patients met all criteria and received an EPM. During the study, 396 patients (7.3%) fully requested an ACT kit. Of these, 209 patients (52.8%) returned the test sample and received genotyping results; 65.5%, had a normal AAT genotype (PI*MM), 31.6% were heterozygotes for a deficient allele (PI*MS, PI*MZ and PI*M/Null rare), and 2.9% had severe deficiency of alpha-1 antitrypsin (PI*SZ, PI*ZZ, PI*S/Null rare).

Conclusion: While the response rate and test return rate were low, the rate of detecting individuals with AATD using this detection strategy exceeds that of many prior strategies. As such, while requiring independent validation in other populations, this detection strategy holds promise.

Citation

Citation: Lam SW, Strange C, Brantly ML, Stoller JK. A novel detection method to identify individuals with alpha-1 antitrypsin deficiency: linking prescription of COPD medications with the patient-facing electronic medical record. J COPD F. 2022; 9(1): 26-33. doi: http://doi.org/10.15326/jcopdf.9.1.2021.0260

Keywords

alpha-1 antitrypsin deficiency, electronic medical record, detection

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Click to read A Novel Detection Method to Identify Individuals with Alpha-1 Antitrypsin Deficiency: Linking Prescription of COPD Medications with the Patient-Facing Electronic Medical Record

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Author Affiliations

1. Education Institute, Cleveland Clinic Foundation, Cleveland, Ohio, United States

Address correspondence to:

James K. Stoller, MD, MS
Education Institute
Cleveland Clinic Foundation
9500 Euclid Avenue
Cleveland, OH 44195
Phone: (216)44-1960
Email: stollej@ccf.org

Abstract

Alpha-1 antitrypsin deficiency (AATD) predisposes to emphysema, liver disease, and panniculitis. This emphysema risk naturally invites a comparison between “regular” chronic obstructive pulmonary disease (COPD) (i.e., unrelated to AATD) and AATD-associated emphysema.

Several features characterize both conditions. Both can be life-limiting and highly debilitating. Both are highly under-recognized.

An important corollary of this comparison between “regular” COPD and AATD-associated COPD is whether both should be treated similarly and whether clinical trials to assess new therapies can be conducted similarly in both. Here, the distinctions between “regular” COPD and AATD-associated COPD are quite pronounced. Therapeutically, sparse available data suggest that lung volume reduction surgery confers less improvement in forced expiratory volume in 1 second (FEV₁) in AATD and that such benefits are shorter-lived. Perhaps the most striking contrast between the 2 conditions is that clinical trial designs and conduct are necessarily very different. The relative scarcity of diagnosed individuals with AATD hampers recruitment to trials. Furthermore, primary outcome measures in trials of “regular” COPD must differ markedly from those of AATD-associated emphysema. Specifically, power calculations show that FEV₁ and exacerbation frequency, which are amply represented as endpoints in large COPD trials, are infeasible in studies of AATD-associated emphysema. Rather, in the 3 available randomized controlled trials of intravenous augmentation therapy, the rate of emphysema progression based on serial computed tomography densitometry measurements has been the only feasible primary outcome measure.

These considerations underscore the distinctive challenges and needs of conducting treatment trials in AATD-associated emphysema and emphasize that, with regard to clinical study design, the 2 conditions are “more unalike than alike.”

Citation

Citation: Stoller JK. Designing clinical trials in “regular” COPD versus alpha-1 antitrypsin deficiency-associated COPD: “more alike than unalike?” J COPD F. 2022; 9(1): 95-102. doi: http://doi.org/10.15326/jcopdf.9.1.2021.0261

Keywords

COPD, alpha-1 antitrypsin deficiency, clinical trials, endotype

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Click to read Designing Clinical Trials in “Regular” COPD Versus Alpha-1 Antitrypsin Deficiency-Associated COPD: “More Alike Than Unalike?”

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Author Affiliations

1. University of Illinois Chicago, Chicago, Illinois, United States
2. Anschutz Medical Campus, University of Colorado, Denver, Colorado, United States
3. University of Nebraska Medical Center, Omaha, Nebraska, United States

Address correspondence to:

Jerry A. Krishnan, MD, PhD
Breathe Chicago Center
Division of Pulmonary, Critical Care, Sleep, and Allergy
University of Illinois Chicago
1220 S. Wood Street, 3^rd floor
Chicago, IL 60608
Phone: (312) 413-0637
Email: jakris@uic.edu

Abstract

This article does not contain an abstract.

Citation

Citation: Krishnan JA, Albert RK, Rennard SI, on behalf of the RELIANCE study. Waiting for actionable evidence: roflumilast or azithromycin? J COPD F. 2022; 9(1): 1-3. doi: http://doi.org/10.15326/jcopdf.9.1.2021.0272

Keywords

chronic obstructive pulmonary disease, roflumilast, azithromycin, RELIANCE

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Click to read Waiting for Actionable Evidence: Roflumilast or Azithromycin?

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Author Affiliations

1. Université of Lille, Université de Artois, Université du Littoral Cote d’Opale, ULR 7369 - URePSSS - Unité de Recherche Pluridisciplinaire Sport Santé Société, Lille, France
2. Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval, Québec, Canada
3. FormAction Santé, Pérenchies, France

Address correspondence to:

Jean-Marie Grosbois
Zone d'Activité du Bois, Rue de Pietralunga
Pérenchies F-59840, France
Phone: +33 3 20 22 04 69
Email: jmgrosbois@formactionsante.com

Abstract

Daily life disability and vulnerability is often reported in patients with chronic obstructive pulmonary disease (COPD) and chronic respiratory failure. Although pulmonary rehabilitation is feasible in this population, its benefits on functional status and physical frailty is uncertain. This study aimed to evaluate the short- and medium-term effectiveness of a home-based pulmonary rehabilitation program in COPD patients with chronic respiratory failure. We also evaluate the impact of frailty status on the efficacy of the intervention.

Forty-seven participants underwent an 8-week home-based program. Functional capacity, physical frailty (Fried criteria), exercise tolerance, health-related quality of life, general fatigue, and anxiety and depressive symptoms were assessed at baseline (M0), and at 8 weeks (M2) and 8 months (M8) following study inclusion.

For the group as a whole, functional capacity, physical frailty, health-related quality of life, and fatigue scores were all improved at M2 and M8 (p<0.05), while exercise tolerance and depressive symptoms were only improved at M8 (p<0.01). However, when the group was divided according to frailty status, only the frail patients had improved health-related quality of life, general fatigue, and anxiety and depressive symptom scores after pulmonary rehabilitation (p<0.05).

In COPD patients with chronic respiratory failure, home-based pulmonary rehabilitation may be effective for improving functional capacity, physical frailty, and health-related quality of life at short- and medium-term. Physical frailty was not a barrier for benefiting from the intervention, and almost 80% of the patients who were frail prior to the program improved their frailty status after pulmonary rehabilitation.

Citation

Citation: Gephine S, Saey D, Grosbois J-M, Maltais F, Mucci P. Home-based pulmonary rehabilitation is effective in frail COPD patients with chronic respiratory failure. J COPD F. 2022; 9(1): 15-25. doi: http://doi.org/10.15326/jcopdf.9.1.2021.0250

Keywords

pulmonary rehabilitation, chronic respiratory failure, frailty, functional capacity, long-term oxygen therapy

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Click to read Home-based Pulmonary Rehabilitation is Effective in Frail COPD Patients with Chronic Respiratory Failure

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Author Affiliations

1. Lung Health Center, Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, University of Alabama, Birmingham, Alabama, United States
2. Denver, Colorado

Address correspondence to:

Takudzwa Mkorombindo, MD
Email: tmkorombindo@uabmc.edu

Abstract

This article does not contain an abstract.

Citation

Citation: Mkorombindo T, Balkissoon R. Journal club: non-invasive mechanical ventilation in stable COPD. J COPD F. 2021; 8(4): 580-588. doi: http://doi.org/10.15326/jcopdf.8.4.2021.0266

Keywords

COPD, chronic obstructive pulmonary disease, non-invasive mechanical ventilation

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Click to read Journal Club: Non-invasive Mechanical Ventilation in Stable COPD

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Author Affiliations

1. Department of Rehabilitation Sciences, KU Leuven–University of Leuven and Respiratory Division, University Hospitals Leuven, Leuven, Belgium
2. Department of Rehabilitation Sciences, Ghent University, Ghent, Belgium
3. Medical Innovation, Value Evidence and Outcomes, GlaxoSmithKline Research and Development, Collegeville, Pennsylvania, United States
4. Reval Rehabilitation Research Center, Biomed Biomedical Research Institute, Hasselt University, Diepenbeek, Belgium
5. Department of Research and Development, CIRO, Horn, Netherlands
6. Digital Biomarkers, GlaxoSmithKline Research and Development, Stevenage, United Kingdom
7. National Jewish Health, Denver, Colorado, United States
8. Rehabilitation Clinical Trials Center, The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, United States
9. Departments of Medicine and Physiology, David Geffen School of Medicine, University of California, Los Angeles, California, United States
10. AstraZeneca Research and Development, Global Regulatory Excellence, Paris, France
11. Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland
12. Boehringer Ingelheim Canada, Burlington, Ontario, Canada
13. National Heart and Lung Institute, Imperial College, London, United Kingdom
14. Respiratory Medicine, Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom
15. BioPharmaceuticals Research and Development Digital Health, AstraZeneca, Gothenburg, Sweden
16. Harefield Respiratory Research Group, Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom
17. Pulmonary, Critical Care, and Sleep Medicine Section, VA Boston Healthcare System, Boston, Massachusetts, United States
18. Harvard Medical School, Boston, Massachusetts, United States
19. Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil
20. Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska, United States
21. Section of Pulmonary, Critical Care and Sleep, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, United States
22. VA Connecticut Healthcare System, West Haven, Connecticut, United States
23. Faculty of Biological Sciences, University of Leeds, Leeds, United Kingdom
24. Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh, Pennsylvania, United States
25. Department of Respiratory Science, University of Leicester, Leicester, United Kingdom
26. COPD Foundation, COPD360 Research, Miami, Florida, United States
27. Department of Sport, Exercise, and Rehabilitation, Northumbria University, Newcastle, United Kingdom
28. Pulmonary Research Institute at LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany
29. McRoberts B.V., The Hague, Netherlands
30. ActiGraph, LLC, Pensacola, Florida, United States
31. Department of Respiratory Medicine, School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, Netherlands
32. ISGlobal, Barcelona, Spain
33. Universitat Pompeu Fabra, Barcelona, Spain
34. CIBER Epidemiología y Salud Pública, Madrid, Spain

Address correspondence to:

Heleen Demeyer, PT, PhD
Herestraat 49, 3000
Leuven, Belgium
Email: Heleen.demeyer@kuleuven.be
Phone: +32 16 37 65 71

Abstract

Physical activity (PA) is of key importance for health among healthy persons and individuals with chronic obstructive pulmonary disease (COPD). PA has multiple dimensions that can be assessed and quantified objectively using activity monitors. Moreover, as shown in the published literature, variable methodologies have been used to date to quantify PA among individuals with COPD, precluding clear comparisons of outcomes across studies. The present paper aims to provide a summary of the available literature for the rationale behind using objectively measured PA and proposes a standardized methodology for assessment, including standard operating procedures for future research.

The present paper, therefore, describes the concept of PA, reports on the importance of PA, summarizes the dimensions of PA, provides a standard operating procedure on how to monitor PA using objective assessments, and describes the psychometric properties of objectively measured PA.

The present international task force recommends implementation of the standard operating procedure for PA data collection and reporting in the future. This should further clarify the relationship between PA and clinical outcomes, test the impact of treatment interventions on PA in individuals with COPD, and successfully propose a PA endpoint for regulatory qualification in the future.

Citation

Citation: Demeyer H, Mohan D, Burtin C, et al. Objectively measured physical activity in patients with COPD: recommendations from an international task force on physical activity. J COPD F. 2021; 8(4): 528-550. doi: http://doi.org/10.15326/jcopdf.8.4.2021.0213

Keywords

physical activity, methodology, accelerometery, standardization

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Click to read Objectively Measured Physical Activity in Patients with COPD: Recommendations from an International Task Force on Physical Activity

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Author Affiliations

1. Evidera, Seattle, Washington, United States
2. Novartis Pharma AG, Basel, Switzerland.
3. Pulmonary and Critical Care Medicine, Department of Medicine, University Medical Centre Giessen and Marburg, Philipps-Universität Marburg, Germany and Member of the German Centre for Lung Research (DZL), Marburg, Germany

Address correspondence to:

Donald Bushnell, MA
Evidera
615 2nd Ave., Suite 500
Seattle, WA 98104
Email: Don.Bushnell@evidera.com

Abstract

Rationale: Patients with chronic obstructive pulmonary disease (COPD) struggle with respiratory symptoms that impair their daily activities and quality of life. Understanding a treatment’s ability to relieve symptoms requires precise assessment. The Evaluating Respiratory Symptoms in COPD (E-RS^TM:COPD) was developed to quantify respiratory symptoms in clinical trials. This review study aimed to better understand how trials use this patient-reported outcome measure as an endpoint, as well as its responsiveness and performance relative to other outcome measures.

Objectives: To summarize the use of the E-RS:COPD in pharmacological trials since its qualification by regulatory authorities.

Methods: A rapid systematic literature review, using key biomedical databases to identify English language full-text publications of randomized controlled trials (RCTs) that included the E-RS:COPD as an endpoint (2010-2020), was conducted. Two investigators independently screened the publications and extracted data.

Measurements and Main Results; Of 219 screened records, 28 full-text publications were included, and data from 17 reporting 20 unique double-blind RCTs were synthesized. The E-RS:COPD was positioned as a primary or secondary endpoint in 6 publications (35%), and served as an exploratory or additional endpoint in 11 (65%). Statistically significant E-RS:COPD treatment effects versus placebo/comparator were found in 13 of the 14 publications reporting symptom results. E-RS:COPD effects corresponded well with other outcome measures (e.g., St George's Respiratory Questionnaire [SGRQ] and forced expiratory volume in 1 second [FEV₁]). Two publications reported the number of responders.

Conclusions; E-RS:COPD is sensitive to treatment effects in clinical trials testing drug therapies. Presentation of trial results should include responder analyses to facilitate interpretation and application of results.

Citation

Citation: Bushnell DM, Wilson R, Gutzwiller FS, et al. Use of the Evaluating Respiratory Symptoms™ in COPD as an outcome measure in clinical trials: a rapid systematic review. J COPD F. 2021; 8(4): 551-571. doi: http://doi.org/10.15326/jcopdf.8.4.2021.0235

Keywords

E-RS:COPD, patient-reported outcome measure, treatment outcome, sensitivity and specificity

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Click to read Use of the Evaluating Respiratory Symptoms™ in COPD as an Outcome Measure in Clinical Trials: A Rapid Systematic Review

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Author Affiliations

1. COPD Foundation, Inc, Washington, DC, United States
2. Department of Epidemiology, College of Public Health, University of Kentucky, Lexington, Kentucky, United States
3. Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, California, United States
4. Oregon Health & Science University, Portland, Oregon, United States
5. Center for Ethics in Health Care, Oregon Health & Science University, Clackamas, Oregon, United States
6. Family and Community Health, University of Minnesota, Minneapolis, Minnesota, United States

Address correspondence to:

Barbara P. Yawn, MD, MSc
Email: byawn47@gmail.com
Phone: (507)261-3096

Abstract

Purpose: Pharmacotherapy is one cornerstone of chronic obstructive pulmonary disease (COPD) management. Published U.S. data seldom includes patient-reported COPD medication use and adherence. We add this patient perspective to the commonly reported administrative prescribing and fill data.

Methods: This survey study used inhaler and nebulizer pictures and lists of oral COPD medications to query members of the COPD Foundation Patient-Powered Research Network, a national, self-reported online registry. Medications used, adherence, inhaler education, cost concerns, previous exacerbations, and COPD Assessment Test scores were assessed and summarized using simple descriptive statistics and hazard ratios controlling for age, gender, and disease burden.

Results: Respondents mean age was 68 years, 60% were women, >69% had COPD Assessment Test (CAT) scores >15, and >50% reported 2 or more exacerbations in the past 12 months. Overall, >98% used 1 or more inhaled COPD medications, 7.6% used a rescue inhaler only, 17.8% used long-acting bronchodilator only therapy (11.1% dual), and 72.8% used corticosteroid therapies, including 53% who were on triple therapy. Nebulizers were used by 59.4% and 34.8% used oral COPD medications. Reported adherence rates were high (80.1%), but 41% reported trouble paying for medications, with 20.1% reporting missing medications due to cost.

Conclusions: In this population, COPD had a high burden with >50% of respondents using triple therapy, and 1 in 8 using maintenance oral corticosteroids. Self-reported adherence was high, but with significant cost concerns reported, resulting in missed medications.

Citation

Citation: Pasquale CB, Choate R, McCreary G, et al. Self-reported COPD medication use and adherence in the COPD Foundation Patient-Powered Research network. J COPD F. 2021; 8(4): 474-487. doi: http://doi.org/10.15326/jcopdf.8.4.2021.0252

Keywords

COPD, therapy, medications, inhalers, nebulizers

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Click to read Self-reported COPD Medication Use and Adherence in the COPD Foundation Patient- Powered Research Network

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Author Affiliations

1. Department of Pharmaceutical and Health Economics, School of Pharmacy, University of Southern California, Los Angeles, California, United States
2. Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles, California, United States
3. Veterans Affairs Long Beach Healthcare System, Long Beach, California, United States
4. Division of Pulmonary and Critical Care Medicine, School of Medicine, University of California, Davis, Sacramento, California, United States
5. Veterans Affairs Northern California Healthcare System, Mather, California, United States

Address correspondence to:

Brooks Kuhn, MD, MAS
University of California, Davis
4150 V Street, Suite 3400
Sacramento, CA 95817
Tel: (415) 847-2172
Email: btkuhn@ucdavis.edu

Abstract

Background: In chronic obstructive pulmonary disease (COPD) patients with exacerbations despite optimized bronchodilator therapy, roflumilast and chronic azithromycin are recommended options. Roflumilast is recommended in severe COPD patients with chronic bronchitis, whereas chronic azithromycin is more broadly indicated. The comparative effectiveness between these 2 treatments to reduce exacerbation rate remains unclear.

Objectives: Our objective was analysis of the Veterans Health Administration (VHA) database (medication and claims data without lung function or presence of chronic bronchitis or tobacco use) to compare the effectiveness of roflumilast and azithromycin on hospitalizations and mortality.

Methods: The primary outcome of the study was cumulative incidences of first COPD-related and all-cause hospitalization. Sensitivity analysis on hospitalizations was conducted for VHA patients who also had Medicare.

Results: In 1302 roflumilast and 2573 azithromycin patients, the all-cause mortality rates at 1 year were 19% and 15%, respectively. The median times-to-all-cause death were 47 months (interquartile range [IQR] 16–81) for the roflumilast and 48 months (IQR 20–83) for the azithromycin groups. Roflumilast was associated with higher mortality (hazard ratio [HR] 1.16; 95% confidence interval [CI], 1.04–1.29). Roflumilast showed no significant association for COPD-related hospitalization (subdistribution HR [SHR]=1.14, 95% CI, 1.00–1.29) and all-cause hospitalization (HR 1.07, 95% CI, 0.97–1.18). For patients with Medicare (N=2030), roflumilast was associated with higher COPD-related (SHR 1.21; 95% CI, 1.05–1.41) and all-cause (SHR 1.23; 95% CI, 1.09–1.38) hospitalizations.

Conclusions: Roflumilast was associated with higher hazard ratios for death, COPD-related hospitalizations, and all-cause hospitalizations in COPD patients only after adjustment for VHA and external Medicare events. Prospective clinical trials are needed to directly compare the relative efficacy of these therapies.

Citation

Citation: Lam J, Tonnu-Mihara I, Kenyon NJ, Kuhn BT. Comparative effectiveness of roflumilast and azithromycin for the treatment of chronic obstructive pulmonary disease. J COPD F. 2021; 8(4): 450-463. doi: http://doi.org/10.15326/jcopdf.8.4.2021.0224

Keywords

roflumilast, azithromycin, OPD exacerbation

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Click to read Comparative Effectiveness of Roflumilast and Azithromycin for the Treatment of Chronic Obstructive Pulmonary Disease

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Author Affiliations

1. COPD Foundation, Miami, Florida, United States
2. Department of Family and Community Health, University of Minnesota, Minneapolis, Minnesota, United States
3. Department of Epidemiology, College of Public Health, University of Kentucky, Lexington, Kentucky, United States
4. Respiratory Therapy Area, GlaxoSmithKline plc., Research Triangle Park, North Carolina, United States
5. Propeller Health, Madison, Wisconsin, United States
6. Respiratory Therapy Area, GlaxoSmithKline plc., Collegeville, Pennsylvania, United States

^* At time of study. RG and LK are currently employed by ResMed. KAC is currently employed by AstraZeneca. BSW is currently employed by United Therapeutics Corporation. DG and RHS is currently employed by AESARA. DAS is currently employed by Propeller Health.

Address correspondence to:

Barbara P. Yawn, MD, MSc
Phone: (507) 261-3096
Email: byawn47@gmail.com

Abstract

Background: Electronic medication monitors (EMMs) are associated with decreased rescue inhaler use, symptom burden, and increased medication adherence in asthma. However, the use of EMMs in people with chronic obstructive pulmonary disease (COPD) using the ELLIPTA dry powder inhaler has not been studied.

Methods: This was an open-label, single-arm, prospective observational study of EMMs and associated application (app) use over 12 weeks and up to 24 weeks (April–October 2019) in people with self-reported COPD aged ≥40 years enrolled in the COPD Patient-Powered Research Network, using an ELLIPTA inhaler. The primary outcome was daily active use of the app over 12 weeks. Treatment adherence, rescue inhaler use, and participant satisfaction were assessed over the same period.

Results: Among the 122 participants, mean (standard deviation [SD]) proportion of days participants opened the app was 59.5% (31.4), 51.1% (33.5) and 41.3% (34.2) for Days 1–30, 31–60 and 61–90, respectively. Mean (SD) adherence to maintenance medication remained stable: 80.2% (22.7) and 79.9% (26.7) for Days 1–30 and 61–90, respectively. In participants using a rescue inhaler and EMM, mean (SD) rescue-free days increased from 18.5 (10.0; Days 1–30, n=51) to 21.4 (9.6; Days 61–90, n=48). Participants reported high levels of confidence in using the EMM, valued app reminders highly, and reported high system satisfaction (mean [SD] scale: 1=low, 5=high; 4.6 [1.1], 4.3 [1.1] and 4.1 [1.1], respectively).

Conclusions: Use of an ELLIPTA EMM with frequent app engagement, high participant satisfaction, and decreased rescue medication use may aid COPD management.

Citation

Citation: Yawn BP, McCreary GM, Linnell JA, et al. Pilot study of a patient experience with an ELLIPTA inhaler electronic medication monitor and associated integrated system: a prospective observational study using the COPD Patient-Powered Research Network. J COPD F. 2021; 8(4): 488-501. doi: http://doi.org/10.15326/jcopdf.8.4.2021.0218

Keywords

chronic obstructive pulmonary disease, dry powder inhaler, real-world, electronic medication monitor, ELLIPTA

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Click to read Pilot Study of a Patient Experience with an ELLIPTA Inhaler Electronic Medication Monitor and Associated Integrated System: A Prospective Observational Study Using the COPD Patient-Powered Research Network

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Author Affiliations

1. Centre de Pneumologie, Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval, Québec, Canada
2. Irish Centre for Genetic Lung Disease, Royal College of Surgeons in Ireland, Dublin, Ireland
3. Alpha-1 Foundation Ireland, Royal College of Surgeons in Ireland, Dublin, Ireland
4. Lakeshore General Hospital, Pointe-Claire, Québec, Canada
5. Montreal Chest Institute, McGill University Health Centre Glen Site, Montreal, Quebec, Canada
6. Meakins-Christie Labs, McGill University of Health Centre Glen Site, Montreal, Quebec, Canada
7. Oscillometry Unit, McGill University of Health Centre Glen Site, Montreal, Quebec, Canada
8. Centre for Innovative Medicine, McGill University Health Centre and Research Institute, and McGill University, Montréal, Quebec, Canada

* These authors have contributed equally to this work

Address correspondence to:

Ronald J. Dandurand, MD
17001 Trans-Canada, Suite 301A
Kirkland, QC
Canada H9H 0A7
E-mail: ronald.dandurand@mcgill.ca
Phone: (514) 694-9287

Abstract

Background: Measuring alpha-1 antitrypsin (AAT) serum levels is often the first step when investigating for alpha-1 antitrypsin deficiency (AATD). The purpose of this study was to determine the test-retest reproducibility of AAT serum levels and to determine if between-measurements variability was associated with acute phase markers of inflammation.

Methods: We retrospectively analyzed a sample of 255 patients from a community respirology practice with chronic obstructive pulmonary disease (COPD) in whom AAT serum levels were measured twice, on separate visits. White blood cell count and fibrinogen were also measured at the time of the second blood sampling as markers of acute phase inflammation. Intraclass correlation coefficient (ICC), Pearson correlation coefficient, and Bland-Altman analysis were used to document test-retest reproducibility. Regression analyses were used to identify potential correlates of test-retest AAT level differences.

Results: Although the 2 AAT serum levels were significantly correlated, the between-measurement agreement was weak (ICC of 0.38 [95% confidence interval (CI), 0.27 to 0.48]; Pearson correlation coefficient of 0.34 [95% CI, 0.23 to 0.44]) and Bland-Altman analysis revealed wide 95% limits of agreement. Considering that an AAT serum level below 1.13 g/L should trigger further investigations to confirm the AAT status, discrepancies between the test-retest AAT levels resulted in reconsidering requirement for further investigation in 22% of patients. A significant correlation between the fibrinogen value and the second AAT level was found (r = 0.21, p = 0.004 [n=173]).

Conclusions: Serum AAT levels showed weak intra-individual reproducibility which could lead to AATD status misclassification and potentially a missed diagnosis of AATD.

Citation

Citation: Haillot A, Pelland A-A, Bosse Y, et al. Intraindividual variability in serum alpha-1 antitrypsin levels. J COPD F. 2021; 8(4): 464-473. doi: http://doi.org/10.15326/jcopdf.8.4.2021.0228

Keywords

diagnosis, alpha-1 antitrypsin deficiency

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Click to read Intraindividual Variability in Serum Alpha-1 Antitrypsin Levels

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Author Affiliations

1. U.S. Health Outcomes and Epidemiology – Vaccines, GSK, Philadelphia, Pennsylvania, United States
2. Health Economics and Outcomes Research, Analysis Group, Inc., Montreal, Quebec, Canada
3. Health Economics and Outcomes Research, Analysis Group, Inc., Boston, Massachusetts, United States
4. U.S. Medical Affairs, GSK, Research Triangle Park, North Carolina, United States
5. Department of Family Medicine and Community Health, University of Minnesota, Minneapolis, Minnesota, United States

*Current affiliation: Health Economics and Outcomes Research, Moderna, Cambridge, Massachusetts, United States
**Current affiliation: Global Commercial Strategy Organization, Janssen, Global Services, LLC, Raritan, New Jersey, United States

Address correspondence to:

Parinaz Ghaswalla, PhD
Health Economics and Outcomes Research
Moderna
Philadelphia, PA 19147
Email: parinaz.k.ghaswalla@gmail.com

Abstract

Background: Patients with chronic obstructive pulmonary disease (COPD) are potentially at increased risk of herpes zoster (HZ). Little is known about the impact of an HZ episode on health care resource utilization (HRU) and costs among patients with COPD.

Methods: This retrospective cohort study of individuals aged ≥50 years in the United States used administrative claims data from Optum’s de-identified Clinformatics Data Mart Database for commercially insured and Medicare Advantage members (2013–2018). Two cohorts of patients with COPD, with HZ (COPD+/HZ+) and without HZ (COPD+/HZ–), were identified. All-cause and COPD-related HRU rates and costs (2018 U.S. dollars) were compared between cohorts for up to 12 months of follow-up. Comparisons were controlled for baseline differences through propensity score adjustment.

Results: A total of 3415 COPD+/HZ+ and 35,360 COPD+/HZ– patients (mean ages 73.2 ± 9.0 and 72.4 ± 9.4 years, respectively) were identified. Patients in the COPD+/HZ+ versus COPD+/HZ– cohort had increased use of all-cause (adjusted incidence rate ratio [aIRR] 1.17; 95% confidence interval [CI] 1.14, 1.21) and COPD-related (aIRR 1.27; 95% CI 1.21, 1.34) medical services (both P<0.001) and higher mean total all-cause ($4140 versus $3749 per person per month [PPPM]; adjusted cost difference +$313 PPPM) and COPD-related ($1541 versus $1231 PPPM; +$152 PPPM) costs (both P<0.004) in the year after HZ.

Conclusions: HRU and cost burden is higher in patients with COPD with versus without HZ. These results could help to estimate the potential cost benefits of HZ vaccination among patients with COPD.

Citation

Citation: Ghaswalla P, Thompson-Leduc P, Cheng WY, et al. Increased health care resource utilization and costs associated with herpes zoster among patients aged ≥50 years with chronic obstructive pulmonary disease in the United States. J COPD F. 2021; 8(4): 502-516. doi: http://doi.org/10.15326/jcopdf.8.4.2021.0222

Keywords

COPD, chronic obstructive pulmonary disease, vaccination, health care resource utilization, herpes zoster, shingles

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Click to read Increased Health Care Resource Utilization and Costs Associated with Herpes Zoster Among Patients Aged ≥50 Years with Chronic Obstructive Pulmonary Disease in the United States

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Author Affiliations

1. Division of Pulmonary, Critical Care and Sleep Medicine Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas, United States
2. Office of Biostatistics, University of Texas Medical Branch, Galveston, Texas, United States
3. Sealy Center on Aging, University of Texas Medical Branch, Galveston, Texas, United States

Address correspondence to:

Daniel A Puebla Neira, MD
301 University Blvd.
Galveston, TX 77555-0561
Email: puebla.daniel@me.com

Abstract

Rationale: There is controversy concerning the association of chronic obstructive pulmonary disease (COPD) as an independent risk factor for mortality in patients hospitalized with coronavirus disease 2019 (COVID-19). We hypothesize that patients with COPD hospitalized for COVID-19 have increased mortality risk.

Objective: To assess whether COPD increased the risk of mortality among patients hospitalized for COVID-19.

Methods: We conducted a retrospective cohort analysis of patients with COVID-19 between February 10, 2020, and November 10, 2020, and hospitalized within 14 days of diagnosis. Electronic health records from U.S. facilities (Optum COVID-19 data) were used.

Results: In our cohort of 31,526 patients, 3030 (9.6%) died during hospitalization. Mortality in patients with COPD was higher than that of patients without COPD, 14.02% and 8.8%, respectively. Univariate (odds ratio [OR] 1.68; 95% confidence interval [CI] 1.54 to 1.84) and multivariate (OR 1.33; 95% CI 1.18 to 1.50) analysis showed that patients with COPD had greater odds of death due to COVID-19 than patients without COPD. We found significant interactions between COPD and sex and COPD and age. Specifically, the increased mortality risk associated with COPD was observed among female (OR 1.62; 95% CI 1.36 to 1.95) but not male patients (OR 1.14; 95% CI 0.97 to 1.34); and in patients aged 40 to 64 (OR 1.42; 95% CI 1.07 to 1.90) and 65 to 79 (OR 1.48; 95% CI 1.23 to 1.78) years.

Conclusions: COPD is an independent risk factor for death in adults aged 40 to 79 years hospitalized with COVID-19 infection.

Citation

Citation: Puebla Neira DA, Watts A, Seashore J, et al. Outcomes of patients with COPD hospitalized for coronavirus disease 2019. J COPD F. 2021; 8(4): 517-527. doi: http://doi.org/10.15326/jcopdf.8.4.2021.0245

Keywords

COPD, chronic obstructive pulmonary disease, mortality, COVID-19

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Click to read Outcomes of Patients with COPD Hospitalized for Coronavirus Disease 2019

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Author Affiliations

1. Jackson Memorial Medical Center, Miami, Florida, United States
2. Miami Veterans Administration Medical Center, Miami, Florida, United States
3. Miller School of Medicine, University of Miami, Miami, Florida, United States

Address correspondence to:

Michael Campos, MD
Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine
University of Miami School of Medicine
1951 NW 7^th Ave, Suite 2278
Miami, FL 33136
Phone: (305) 243-6388
Email: mcampos1@med.miami.edu

Abstract

Background: Studies have shown a decline in hospitalizations due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) during the coronavirus disease 2019 (COVID-19) pandemic. However, the impact of the pandemic on AECOPDs of all severities in longitudinal cohorts of patients is lacking.

Methods: We conducted analysis of 123 individuals with COPD who have been followed since 2017. AECOPDs of mild (treatment at home), moderate (emergency department or urgent visit evaluation), and severe (hospitalization) type were assessed by chart review and patient interview. Compliance with preventive measures to avoid COVID-19 infection was assessed in 2020. Differences between the rate of AECOPD by year was analyzed as well as differences in preventive measures by COPD disease severity.

Results: During the COVID-19 pandemic in 2020, there was a significant reduction in AECOPDs in our cohort with 26 participants (21%) having an exacerbation compared to 46 (37%) in 2019, 52 (42%) in 2018, and 44 (36%) in 2017. Mean exacerbation rates decreased 54% overall and 74% in frequent exacerbators compared with the prior 3-year average. The decrease was noted in AECOPDs of all severities. Overall, there was a high rate of reported compliance with social distancing and face mask use that was significantly higher in the group with more severe COPD based on symptoms and forced expiratory volume in 1 second.

Conclusions: Individuals with COPD, including frequent exacerbators, showed a marked decrease in AECOPD during the COVID-19 pandemic and high adherence to recommended preventive measures. Evaluation of the impact of preventive strategies on AECOPD in a non-pandemic setting may be of value and requires further study.

Citation

Citation: Trujillo C, Garnet B, Zadeh AV, Urdaneta G, Campos M. Decrease in exacerbations during the coronavirus disease 2019 pandemic in a cohort of veterans with COPD. J COPD F. 2021; 8(4): 572-579. doi: http://doi.org/10.15326/jcopdf.8.4.2021.0234

Keywords

COPD, exacerbations, COVID-19

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Click to read Decrease in Exacerbations During the Coronavirus Disease 2019 Pandemic in a Cohort of Veterans with COPD

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Author Affiliations

1. Division of Pulmonary, Critical Care, and Sleep Medicine, College of Medicine, University of Cincinnati, Cincinnati, Ohio, United States
2. Department of Veterans Affairs, Cincinnati VA Hospital, Cincinnati, Ohio, United States

Address correspondence to:

Robert M. Burkes, MD, MSCR
Division of Pulmonary, Critical Care, and Sleep Medicine
College of Medicine
University of Cincinnati
231 Albert Sabin Way
Cincinnati, OH 45229
Phone: (513)558-4831
Email: burkesrt@ucmail.uc.edu

Abstract

Background: Cytomegalovirus (CMV) represents an understudied chronic infection, usually contracted early in life, that causes chronic immune system alterations which may contribute to airflow limitations in a cohort of veterans with a high prevalence of smoking. We studied 172 participants at-risk for and with airflow limitation with available CMV serology to assess the relationship between CMV infection and chronic obstructive pulmonary disease (COPD)-related outcomes.

Methods: The study cohort includes 172 veterans who are smokers with or at risk for the development of COPD. Clinical data were obtained by chart abstraction at enrollment. CMV affinity (ever-exposure) and avidity testing (length of exposure) were performed on plasma samples collected at enrollment. Bivariable and multivariable logistic regression was used to determine the relationship between both cytomegalovirus affinity and avidity and odds of prevalent airflow limitation (post-bronchodilator forced expiratory volume in 1 second to forced vital capacity ratio <0.70) at enrollment. In those with airflow limitation (n=84), bivariable and multivariable logistic regression was used to determine relationships between CMV serostatus and reported exacerbations of COPD over 2 years prior to enrollment.

Results: Positive CMV serostatus was independently associated with a 136% higher odds of airflow limitation (95% confidence interval 1.11–5.06, P=0.03) at enrollment. Neither CMV affinity nor avidity was associated with COPD exacerbations in the 2 years prior to enrollment.

Conclusion: CMV serostatus is independently associated with airflow limitation in a cohort of veterans who smoke. Investigation into the timing of infection and alterations in cellular immunity caused by chronic CMV infection and smoking-related airways disease-related outcomes is warranted.

Citation

Citation: Burkes R, Osterburg A, Hwalek T, Lach L, Panos RJ, Borchers MT. Cytomegalovirus seropositivity is associated with airflow limitation in a cohort of veterans with a high prevalence of smoking. J COPD F. 2021; 8(4): 441-449. doi: http://doi.org/10.15326/jcopdf.8.4.2021.0221

Keywords

COPD, COPD outcomes, viral infections, airflow limitation, cytomegalovirus

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Click to read Cytomegalovirus Seropositivity is Associated with Airflow Limitation in a Cohort of Veterans with a High Prevalence of Smoking

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Author Affiliations

1. Division of Research, Kaiser Permanente Northern California, Oakland, California, United States
2. Department of Emergency Medicine, Massachusetts General Hospital, Boston, Massachusetts, United States

Address correspondence to:

Laura Myers, MD, MPH
Division of Research
Kaiser Permanente Northern California
2000 Broadway
Oakland, CA 94612
Email: laura.c.myers@kp.org
Phone: (925) 433-3491

Abstract

Rationale: Clinical trials outside of the United States have assessed whether pulmonary rehabilitation (PR) decreases readmission rates for chronic obstructive pulmonary disease (COPD). We investigated if PR was associated with lower readmission risk for Medicare patients hospitalized for COPD.

Methods: We identified adults enrolled in Medicare hospitalized for COPD exacerbation from a random sample of 5 million Medicare beneficiaries (2010-2012). Patients received PR if they attended ≥1 outpatient session. A cohort was identified to study non-elective, 30-day all-cause readmissions; a subcohort was identified to study 1-year all-cause readmissions. We used stabilized inverse probability weights to balance groups by patient demographics, comorbidities, frailty, smoking status, and long-term oxygen use. We performed cause-specific regression with death as a competing risk.

Results: Of 1,839,827 hospitalizations from 2011-2012, we identified 78,074 for COPD. The 30-day cohort contained 7825 COPD index hospitalizations, of which 235 (3%) received PR; the1-year cohort contained 3401, of which 108 (3%) received PR. The median number of PR sessions was 3 (interquartile range 1-11) for both cohorts. The hazard ratio for 30-day readmission was 0.47 (95% confidence interval [CI] 0.33-0.68, P<0.0001). The hazard ratio for 1-year readmission was 1.45 (95% CI 1.19-1.76, P<0.001).

Conclusions: This is one of the first studies of PR and readmissions in Medicare patients. We found that PR was associated with a lower risk of 30-day all-cause readmissions but a higher risk of 1-year all-cause readmission.

Citation

Citation: Myers LC, Faridi MK, Hasegawa K, Camargo CA. Pulmonary rehabilitation and readmission rates for Medicare beneficiaries with acute exacerbation of chronic obstructive pulmonary disease J COPD F. 2021; 8(4): 427-440. doi: http://doi.org/10.15326/jcopdf.8.4.2020.0193

Keywords

chronic obstructive pulmonary disease, pulmonary rehabilitation

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Click to read Pulmonary Rehabilitation and Readmission Rates for Medicare Beneficiaries with Acute Exacerbation of Chronic Obstructive Pulmonary Disease

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Author Affiliations

1. School of Medicine, Johns Hopkins University, Baltimore, Maryland, United States
2. Center for Clinical Trials and Evidence Synthesis, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States
3. School of Medicine, Temple University, Philadelphia, Pennsylvania, United States
4. Lung Health Center, University of Alabama at Birmingham, Birmingham, Alabama, United State
5. School of Medicine, University of Michigan, Ann Arbor, Michigan, United States
6. Breathe Chicago Center, University of Illinois at Chicago, Chicago, Illinois, United States
7. St. Vincent’s Medical Center, Indianapolis, Indiana, United States
8. University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

Address correspondence to:

Robert A. Wise, MD
415 N Washington Street, 2^nd Floor
Baltimore, Maryland
Phone: 410 905-5688
rwise@jhmi.edu

Abstract

The Losartan Effects on Emphysema Progression (LEEP) trial was designed to test the hypothesis that losartan slows progression of emphysema in chronic obstructive pulmonary disease (COPD) patients (NCT00720226). It was conducted by the Pulmonary Trials Cooperative consortium, in collaboration with the American Lung Association Airways Clinical Research Centers network. We describe the design of the trial and challenges for recruitment and follow-up of participants.

LEEP is a placebo-controlled, parallel randomized trial, allocation ratio of 1:1, with a planned sample size of 220. Primary eligibility criteria were mild emphysema based on high-resolution computed tomography (HRCT) scans with 5% to 35% voxels <-950 Hounsfield units (HU), airway obstruction based on spirometry, and not taking an angiotensin receptor blocker or angiotensin converting enzyme (ACE) inhibitor. Participants received either losartan or placebo for 48 weeks.

A total of 2779 individuals were screened to enroll 220 eligible participants at 26 clinical sites, all located in the continental United States. Recruitment took 45% longer than planned (32 months versus 22 months), with an average accrual rate of 6.7 participants per month. Recruitment challenges included identification of eligible participants who were not already taking or who did not have an established clinical indication for an angiotensin receptor blocker or ACE inhibitor drug and recalls of contaminated lots of losartan by the Food and Drug Administration. A number of recruitment initiatives were launched in response. Recruitment was completed in February 2020, just prior to a nationwide shutdown of research activities due to the coronavirus disease 2019 (COVID-19) pandemic.

Citation

Citation: American Lung Association Airways Clinical Research Centers. Wise R, Holbrook JT, Brown RH, et al. Losartan effects on emphysema progression randomized clinical trial: rationale, design, recruitment, and retention. J COPD F. 2021; 8(4): 414-426. doi: http://doi.org/10.15326/jcopdf.8.4.2021.0210

Keywords

COPD, losartan, emphysema, computed tomography, clinical trial

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Click to read Losartan Effects on Emphysema Progression Randomized Clinical Trial: Rationale, Design, Recruitment, and Retention

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Author Affiliations

1. Editor in Chief, Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation
2. Lung Health Center, Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Alabama, United States

Address correspondence to:

Mark Dransfield, MD
Email: mdransfield@uabmc.edu

Abstract

This article does not contain an abstract.

Citation

Citation: Dransfield M. Editorial: Thank you all, now onwards and upwards! J COPD F. 2021; 8(3): 303-305. doi: http://doi.org/10.15326/jcopdf.8.3.2021.0247

Keywords

There are no keywords for this article.

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Click to read Thank You All, Now Onwards and Upwards!

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Author Affiliations

1. Lung Health Center, Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, University of Alabama, Birmingham, Alabama, United States
2. Denver, Colorado

Address correspondence to:

Takudzwa Mkorombindo, MD
Email: tmkorombindo@uabmc.edu

Abstract

This article does not contain an abstract.

Citation

Citation: Mkorombindo T, Balkissoon R. Journal club: respiratory impact of wildfire smoke. J COPD F. 2021; 8(3): 408-413. doi: http://doi.org/10.15326/jcopdf.8.3.2021.0244

Keywords

wildfire smoke, environmental-related respiratory events

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Click to read Journal Club: Respiratory Impact of Wildfire Smoke

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Author Affiliations

1. Florida Lung Asthma and Sleep Specialists, Kissimmee, Florida, United States

Address correspondence to:

Fortune O. Alabi, MD
3480 Polynesian Isles Blvd.
Kissimmee, FL 34746
Phone: 407-507-2615
Email: Falabi@floridalungdoctors.com

Abstract

Background: Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease with differing clinical presentations, which range from an asymptomatic obstructive defect on spirometry to symptomatic normal spirometry. The current standard for diagnosis requires exposure history and the presence of an obstructive ventilatory defect (forced expiratory volume in 1 second [FEV₁] to forced vital capacity [FVC] ratio < 70%) on spirometry. In this real-world study, we analyzed patients with physician-diagnosed COPD, described their characteristics, and evaluated the diagnostic sensitivity of Global initiative for chronic Obstructive Lung Disease (GOLD) criteria in this population.

Methods: We retrospectively analyzed the charts of 2115 patients for eligibility. A total of 1224 patients with physician-diagnosed COPD were selected for this study. The average age was 68.4±11.5 years, with 51% being female. Of the 1224 patients, 18% did not have a history of smoking, 73% had bronchodilator testing, and a significant response of ≥12% was noted in 23% of the COPD patients. Moreover, 43% of the patients met the GOLD criteria for the diagnosis of COPD, whereas the Global Lung Function Initiative (GLI) and lower limit of normal (LLN)criteria were only able to identify 26%.

Discussion: COPD-related mortality is continuing to rise, and it is currently ranked as the third leading cause of death, globally, after cardiovascular diseases and strokes. Despite this alarming statistic, COPD diagnosis is delayed in most cases and can remain undiagnosed, even in smokers. This is partly due to the restrictive GOLD diagnostic criteria, which requires the presence of FEV₁/FVC ratio<70.

Conclusion: The recently proposed COPD Genetic Epidemiology (COPDGene^®) 2019 definition for COPD will improve and enhance our ability to diagnose COPD earlier and more accurately.

Citation

Citation: Alabi FO, Alkhateeb HA, DeBarros KM, et al. The heterogeneity of COPD patients in a community-based practice and the inadequacy of the Global Initiative for Chronic Obstructive Lung Disease criteria: a real-world experience. J COPD F. 2021; 8(3): 396-407. doi: http://doi.org/10.15326/jcopdf.8.3.2021.0229

Keywords

chronic obstructive pulmonary disease, spirometry, GOLD, COPDGene, pulmonary function test

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Click to read The Heterogeneity of COPD Patients in a Community-Based Practice and the Inadequacy of the Global Initiative for Chronic Obstructive Lung Disease Criteria: A Real-World Experience

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Author Affiliations

1. Pulmonary and Critical Care Division, Department of Internal Medicine, UF Health-Shands Hospital, University of Florida, Gainesville, Florida, United States
2. Advent Health Medical Group, Central Florida Division, Orlando, Florida, United States
3. Pulmonary and Critical Care Division, Department of Internal Medicine, University of Miami Health Systems, Miami, Florida, United States

*medical student

Address correspondence to:

Jason B. Katz
MD-candidate
College of Medicine
University of Florida
Phone : (727)288-8356
Email : jasonbkatz@ufl.edu

Abstract

Purpose: Endothelial and platelet microparticles (eMPs and pMPs), markers of cellular activation, dysfunction, or apoptosis, have been associated with multiple cardiovascular conditions. Chronic obstructive pulmonary disease (COPD) is associated with cardiovascular comorbidities and platelet/endothelial dysfunction. We analyzed whether eMPs and pMPs are associated with COPD status and/or severity.

Patients and Methods: A total of 58 COPD patients and 19 controls were enrolled and followed for an average of 1.17 years. Characterization of COPD included lung function, Body mass index-airflow Obstruction-Dyspnea-Exercise (BODE) scores, health-related quality of life, exacerbations, comorbidities, and mortality. Plasma collection to measure eMPs and pMPs via flow cytometry was performed at enrollment as well as during acute exacerbation in 17 participants. We measured pMPs (CD31+, CD41+31+, CD 62P+), eMPs (ULEX lectin+, CD51+, CD54+, CD62E+), the apoptotic CD62E+/CD31+ ratio, and Annexin V MP.

Results: As a group, COPD participants had no difference in all MP levels studied compared with controls. No significant correlations with diffusion capacity for carbon monoxide, quality of life, and exacerbation status were found in all MPs studied. However, the eMP ULEX and the pMP CD 62P+ were higher among COPD Global initiative for chronic Obstructive Lung Disease (GOLD) stage 3 patients compared to controls. The CD62E+/CD31+ ratio was lower in controls and GOLD stage 1 COPD participants compared with GOLD stage 2/3 COPD participants, suggesting increased apoptosis. eMP ULEX lectin+ decreased during acute exacerbations and pMP41+31+ significantly increased as BODE score increased.

Conclusion: After adjusting for comorbidities, most eMPs and pMPs studied do not correlate significantly with COPD status or severity.

Citation

Citation: Lascano J, Katz J, Cearras M, Campos M.Association of systemic endothelial-derived and platelet-derived microparticles with clinical outcomes in chronic obstructive pulmonary disease. J COPD F. 2021; 8(3): 382-395. doi: http://doi.org/10.15326/jcopdf.8.3.2021.0211

Keywords

COPD, Lung, endothelium, platelets, microparticles

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Click to read Association of Systemic Endothelial-Derived and Platelet-Derived Microparticles With Clinical Outcomes in Chronic Obstructive Pulmonary Disease

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Author Affiliations

1. Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland, United States
2. Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, California, United States
3. Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York, United States
4. Division of Pulmonary, Critical Care and Sleep Medicine, National Jewish Health, Denver, Colorado, United States
5. Division of Pulmonary, Critical Care, and Occupational Medicine, College of Medicine, University of Iowa, Iowa City, Iowa, United States
6. Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
7. Department of Thoracic Surgery and Medicine, Temple University, Philadelphia, Pennsylvania, United States
8. Division of Pulmonary, Allergy and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, United States
9. Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, Michigan, United States
10. Department of Radiology, Medicine and Biomedical Engineering, University of Iowa, Iowa City, Iowa, United States
11. Division of Respiratory, Critical Care and Occupational Medicine, University of Utah, Salt Lake City, Utah, United States
12. Division of Pulmonary, Critical Care, Sleep, and Allergy, University of Illinois at Chicago, Chicago, Illinois, United States
13. Division of Pulmonology and Critical Care Medicine, Weill-Cornell Medical Center, Cornell University, New York, New York, United States
14. Section on Pulmonary, Critical Care, Allergy and Immunologic Diseases, Wake Forest University, Winston-Salem, North Carolina, United States
15. Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Francisco, San Francisco, California, United States

Address correspondence to:

Ashraf Fawzy, MD, MPH
5501 Hopkins Bayview Circle
Baltimore, MD 21224
Email: afawzy1@jhmi.edu

Abstract

Secondary polycythemia has long been recognized as a consequence of chronic pulmonary disease and hypoxemia and is associated with lower mortality and fewer hospitalizations among individuals with chronic obstructive pulmonary disease (COPD)-prescribed long-term oxygen therapy. This study investigates the association of polycythemia with COPD severity, phenotypic features, and respiratory exacerbations in a contemporary and representative sample of individuals with COPD. Current and former smokers with COPD (forced expiratory volume in 1 second [FEV₁] to forced vital capacity [FVC] ratio <70%) without a history of hematologic/oncologic disorders were selected from the SubPopulations and InteRmediate Outcomes Measures In COPD Study (SPIROMICS), a multi-center observational cohort. Participants with polycythemia (hemoglobin ≥15g/dL [females] or ≥17g/dL [males]), were compared to individuals without anemia (hemoglobin ≥12g/dL [females] or ≥13g/dL [males]). Cross-sectional outcomes including percent predicted FEV₁, respiratory symptoms, quality of life, exercise tolerance, and percentage and distribution of emphysema (voxels<-950 Hounsfield units [HU] at total lung capacity) were evaluated using linear or logistic regression. Longitudinal acute exacerbation of COPD (AECOPD) and severe AECOPD (requiring an emergency department visit or hospitalization) were assessed using zero-inflated negative binomial models. Among 1261 participants, 148 (11.7%) had polycythemia. Average follow-up was 4.2±1.7 years and did not differ by presence of polycythemia. In multivariate analysis, compared to participants with normal hemoglobin, polycythemia was associated with a reduced rate of severe AECOPD (adjusted incidence rate ratio 0.57, 95% CI: 0.33-0.98), lower percent predicted FEV₁, lower resting oxygen saturation, increased upper to lower lobe ratio of emphysema, and a greater degree of emphysema, though the latter was attenuated after adjusting for lung function. There were no significant differences in total AECOPD, patient-reported outcomes, or exercise tolerance. These findings suggest that polycythemia, while associated with less favorable physiologic parameters, is not independently associated with symptoms, and is associated with fewer severe exacerbations. Future studies should explore the potentially protective role of increased hemoglobin beyond the correction of anemia.

Citation

Citation: Fawzy A, Woo H, Balasubramanian A, et al. Polycythemia is associated with lower incidence of severe COPD exacerbations in the SPIROMICS study. J COPD F. 2021; 8(3): 326-335. doi: http://doi.org/10.15326/jcopdf.8.3.2021.0216

Keywords

acute exacerbation of COPD, SPIROMICS, polycythemia

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Click to read Polycythemia is Associated with Lower Incidence of Severe COPD Exacerbations in the SPIROMICS Study

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Author Affiliations

1. University of Minnesota, Minneapolis, Minnesota, United States
2. HealthPartners Institute, Bloomington, Minnesota, United States
3. RespirTech, a Philips company, St. Paul, Minnesota, United States

Address correspondence to:

Charlene McEvoy, MD, MPH
HealthPartners Institute
8170 33rd Avenue South, MS23301A
Bloomington, MN 55425
Email: Charlene.E.McEvoy@HealthPartners.com
Phone: (612) 845-6711

Abstract

Purpose: To assess whether the presence or absence of bronchiectasis has an impact on the patient-reported symptoms of chronic obstructive pulmonary disease (COPD) patients.

Methods: The study included participants from the COPD Genetic Epidemiology Study (COPDGene^®) cohort with available high-resolution chest tomography reporting the presence or absence of bronchiectasis (BE+/BE-) and survey data reporting the presence or absence of chronic bronchitis symptoms (CB+/CB-). Patient symptoms based on the St George’s Respiratory Questionnaire (SGRQ) were then compared for the different groups.

Results: The study population included 7976 participants, mean age 60, Global initiative for chronic Obstructive Lung Disease (GOLD) stages 0 to 4, 18.8% BE+, and 19.5% CB+. The presence or absence of radiographic bronchiectasis was not associated with higher frequency of chronic bronchitis (GOLD 0 group odds ratio [OR] 1.01 [0.78,1.31], GOLD 1–2 group OR 1.19 [0.95, 1.50], GOLD 3–4 group OR 1.26 [0.99, 1.60]). Similarly, CB+ participants had higher SGRQ scores than CB- participants regardless of the presence of BE.

Conclusions: Across all GOLD stages, chronic bronchitis symptoms are associated with worse pulmonary symptoms and significant impairment in quality of life. For patients with chronic bronchitis, the presence or absence of bronchiectasis is not associated with a significant difference in SGRQ symptom scores. Symptoms of chronic bronchitis impose a heavy burden on patients and should be treated regardless of the presence or absence of underlying bronchiectasis.

Citation

Citation: Bohn O, Xi M, Woodruff NK, Hansen GL, McEvoy CE; COPDGene investigators. Chronic bronchitis in COPD patients creates worse symptom burden regardless of the presence of bronchiectasis in the COPDGene cohort. J COPD F. 2021; 8(3): 350-359. doi: http://doi.org/10.15326/jcopdf.8.3.2021.0202

Keywords

chronic bronchitis, GOLD, bronchiectasis, St George’s Respiratory Questionnaire, Global initiative for chronic Lung Disease

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Click to read Chronic Bronchitis in COPD Patients Creates Worse Symptom Burden Regardless of the Presence of Bronchiectasis in the COPDGene Cohort

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Author Affiliations

1. Division of Pulmonary and Critical Care Medicine, the University of Texas Health Science Center at Tyler, Tyler, Texas, United States
2. National Bronchiectasis Research Registry, COPD Foundation, Washington, DC, United States
3. Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, Minnesota, United States

Address correspondence to:

Pamela J. McShane, MD
Division of Pulmonary and Critical Care Medicine
The University of Texas Health Science Center at Tyler
11937 US Hwy 271
Tyler, TX 75708
Phone: (847) 226-8410
Email: pamela.mcshane@uthct.edu

Abstract

This article does not contain an abstract.

Citation

Citation: McShane PJ, Philley JV, Prieto DA, Aksamit TR. Global attitudes of health care providers about aerosolized airway clearance therapy in bronchiectasis patients during the coronavirus disease 2019 pandemic. J COPD F. 2021; 8(3): 319-325. doi: http://doi.org/10.15326/jcopdf.8.3.2021.0214

Keywords

COPD, bronchiectasis, aerosol therapy, airway clearance

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Click to read Global Attitudes of Health Care Providers About Aerosolized Airway Clearance Therapy in Bronchiectasis Patients During the Coronavirus Disease 2019 Pandemic

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Author Affiliations

1. Division of Pulmonary Sciences and Critical Care Medicine, Denver Anschutz Medical Campus, University of Colorado, Aurora, Colorado, United States
2. Department of Medicine, Division of Healthcare Policy and Research, Denver Anschutz Medical Campus, University of Colorado, Aurora, Colorado, United States
3. Department of Family Medicine, Denver Anschutz Medical Campus, University of Colorado, Aurora, Colorado, United States
4. High Plains Research Council Community Advisory Council, Denver Anschutz Medical Campus, University of Colorado, Aurora, Colorado, United States
5. Wyoming Institute for Disabilities, University of Wyoming, Laramie, Wyoming, United States
6. Center for Rural Health, University of North Dakota School of Medicine and Health Sciences, Grand Forks, North Dakota, United States
7. Department of Family Medicine and Community Health, University of Kansas Medical Center, Kansas City, Kansas, United States

*Contributed equally to the manuscript.

Address correspondence to:

R. William Vandivier, MD
Division of Pulmonary Sciences and Critical Care Medicine
University of Colorado Denver
12700 E 19^th Ave, Campus Box C272
Aurora, CO 80045
Phone: (303)724-6068 E-mail: Bill.Vandivier@cuanschutz.edu

Abstract

Rationale: Rural chronic obstructive pulmonary disease (COPD) patients have worse outcomes and higher mortality compared with urban patients. Reasons for these disparities likely include challenges to delivery of care that have not been explored.

Objective: To determine challenges faced by rural primary care providers when caring for COPD patients.

Methods: Rural primary care providers in 7 primarily western states were asked about barriers they experienced when caring for COPD patients.

Results: A total of 71 rural primary care medical providers completed the survey, of which 51% were physicians and 49% were advanced practice providers (APPs). A total of 61% used Global Initiative for Chronic Obstructive Lung Disease or American Thoracic Society/European Respiratory Society guidelines as an assessment and treatment resource. The presence of multiple chronic conditions and patient failure to recognize and report symptoms were the greatest barriers to diagnose COPD. A total of 89% of providers used spirometry to diagnose COPD, but only 62% were satisfied with access to spirometry. Despite recommendations, 41% of providers never test for alpha-1 antitrypsin deficiency. A total of 87% were comfortable with their ability to assess symptoms, but only 11% used a guideline-recommended assessment tool. Although most providers were satisfied with their ability to treat symptoms and exacerbations, only 66% were content with their ability to prevent exacerbations. Fewer providers were happy with their access to pulmonologists (55%) or pulmonary rehabilitation (37%). Subgroup analyses revealed differences based on provider type (APP versus physician) and location (Colorado and Kansas versus other states), but not on population or practice size.

Conclusions: Rural providers face significant challenges when caring for COPD patients that should be targeted in future interventions to improve COPD outcomes.

Citation

Citation: Diaz del Valle F, Koff PB, Min SJ, et al.Challenges faced by rural primary care providers when caring for COPD patients in the western United States. J COPD F. 2021; 8(3): 336-349. doi: http://doi.org/10.15326/jcopdf.8.3.2021.0215

Keywords

COPD Assessment Test, primary care, health care delivery, guidelines, symptom assessment

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Click to read Challenges Faced by Rural Primary Care Providers When Caring for COPD Patients in the Western United States

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Author Affiliations

1. Department of Internal Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
2. Division of Pulmonary, Critical Care, and Sleep Medicine, University of Cincinnati, Cincinnati, Ohio, United States
3. Division of Pulmonary Diseases and Critical Care Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
4. Division of Endocrinology, Diabetes, and Metabolism, Johns Hopkins University, Baltimore, Maryland, United States
5. Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland, United States

Address correspondence to:

M. Bradley Drummond, MD, MHS
Marsico Hall Room 7207, CB# 7248
125 Mason Farm Road
Chapel Hill, NC 27599
Phone: (919) 966-7054
brad_drummond@med.unc.edu

Abstract

Introduction: Cathelicidin is a vitamin D-regulated, antimicrobial peptide involved in the innate immune response of the airways. Reduced plasma cathelicidin concentrations are independently associated with worse pulmonary outcomes in current and former smokers. This study aimed to determine whether oral vitamin D supplementation in vitamin D-deficient current smokers increases plasma and bronchoalveolar lavage (BAL) cathelicidin levels.

Methods: Vitamin D-deficient (25-hydroxy vitamin D [25-OH vitamin D] <20 ng/ml) smokers (n=17) underwent collection of plasma and BAL for cathelicidin and 25-OH vitamin D measurements before and after 8 weeks of oral supplementation with 50,000 IU vitamin D3 weekly. Differences between baseline and 8-week levels of cathelicidin and 25-OH vitamin D in blood and BAL were assessed along with correlations between serum 25-OH vitamin D, plasma cathelicidin, and BAL cathelicidin.

Results: At baseline, there was no correlation between BAL and plasma cathelicidin. There was a significant increase in 25-OH vitamin D (median 17.0 to 43.3 ng/mL, p<0.001) after 8 weeks of vitamin D supplementation. There was no change in plasma cathelicidin (p=0.86), BAL cathelicidin (p=0.31), or BAL 25-OH vitamin D (p=0.89). There was no correlation between serum 25-OH vitamin D and either BAL or plasma cathelicidin post-supplementation.

Conclusion: Oral vitamin D supplementation, while increasing serum 25-OH vitamin D levels, does not increase plasma or BAL cathelicidin levels in vitamin D-deficient, active smokers. The lack of increased BAL cathelicidin may be explained by multiple factors related to dosing, smoking effects, or putative mechanisms of engagement. Future studies are needed to determine the effects of vitamin D supplementation on lung and blood functional activity.

Citation

Citation: Sanders EC, Burkes RM, Mock JR, et al. Bronchoalveolar lavage and plasma cathelicidin response to 25-hydroxy vitamin D supplementation: a pilot study. J COPD F. 2021; 8(3): 371-381. doi: http://doi.org/10.15326/jcopdf.8.3.2021.0220

Keywords

biomarkers, vitamin D, antimicrobial cationic peptides

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Click to read Bronchoalveolar Lavage and Plasma Cathelicidin Response to 25-Hydroxy Vitamin D Supplementation: A Pilot Study

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Author Affiliations

1. National Jewish Health, Denver Colorado, United States
2. Department of Epidemiology, Colorado School of Public Health, Aurora, Colorado, United States
3. Department of Community and Behavioral Health, Colorado School of Public Health, Aurora, Colorado, United States

Address correspondence to:

Elizabeth A. Regan, MD, PhD
National Jewish Health
1400 Jackson St
Denver CO 80206
Phone: (303)398-1531
Email: Regane@njhealth.org

Abstract

Introduction: Smoking cessation counseling is a central part of the Medicare guidelines for lung cancer screening. With increasing age, many heavy smokers eventually stop smoking, however, factors influencing the decision to stop smoking are poorly understood. We postulated that declining health or physician-diagnosis of a medical condition may be associated with successful smoking cessation.

Methods: A total of 4448 current and former smokers in Phase 2 of the COPD Genetic Epidemiology (COPDGene®) study answered a question about reasons for stopping smoking. Participants were classified as successful quitters (n=3345), and unsuccessful quitters (n=1003). Reasons cited for quitting were grouped as: medical diagnoses, social factors, symptoms. Logistic modeling of factors associated with successful quitting were adjusted for age, gender, race, and education.

Results: The most common factors cited for a quit attempt by all respondents were medical diagnoses (48%), followed by social factors (47%), and respiratory symptoms (36%). Successful quitters were more likely to be older, male, and non-Hispanic White. An adjusted model found increased age, White race, education beyond high school, and male sex favored successful quitting while the cited medical diagnoses, social factors, and “other” reasons were associated with unsuccessful quitting. Fagerstrom Nicotine Dependence scores were ³ 5 in 54% of the unsuccessful group compared to 45% for successful quitters(p<0.0001) suggesting some increased nicotine dependence in the unsuccessful quitters.

Conclusions: Medical diagnosis was the most common factor cited for considering a quit attempt by both successful and unsuccessful quitters; however, successful quitting was influenced by demographic factors and potentially the severity of nicotine dependence.

Citation

Citation: Lindsay HG, Wamboldt FS, Holm KE, et al; and the COPDGene Investigators. Impact of a medical diagnosis on decision to stop smoking and successful smoking cessation. J COPD F. 2021; 8(3): 360-370. doi: http://doi.org/10.15326/jcopdf.8.3.2020.0167

Keywords

COPD, smoking cessation, medical diagnoses, social factors, smoking symptoms

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Click to read Impact of a Medical Diagnosis on Decision to Stop Smoking and Successful Smoking Cessation

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Author Affiliations

1. Research Department, COPD Foundation, Washington, DC, United States
2. COPD Patient-Powered Research Network Governing Board, COPD Foundation, Washington, DC, United States
3. Patient investigator for the COPD Foundation, Washington, DC, United States
4. Community Engagement, COPD Foundation, Washington, DC, United States
5. Kaiser Permanente Center for Health Research, Portland, Oregon, United States

Address correspondence to:

Barbara P. Yawn, MD, MSc
Email: byawn47@gmail.com

Abstract

This article does not contain an abstract.

Citation

Citation: McCreary G, Boyce D, Houlihan ME, et al. Patient-driven research agenda: what needs to be studied in those living with COPD during the coronavirus disease 2019 pandemic. J COPD F. 2021; 8(3): 314-318. doi: http://doi.org/10.15326/jcopdf.8.3.2021.0203

Keywords

COPD, chronic obstructive pulmonary disease, COVID-19, pandemic, research priorities

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Click to read Patient-Driven Research Agenda: What Needs to be Studied in Those Living with COPD During the Coronavirus Disease 2019 Pandemic

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Author Affiliations

1. Breathe Chicago Center, Division of Pulmonary, Critical Care, Sleep, and Allergy, University of Illinois at Chicago, Chicago, Illinois, United States
2. Population Health Sciences Program, University of Illinois Hospital and Health Sciences System, University of Illinois at Chicago, Chicago, Illinois, United States
3. Department of Medicine, Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School - Baystate, Springfield, Massachusetts, United States
4. Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, Massachusetts, United States
5. Health Services Research and Development, VA Puget Sound, Seattle, Washington, United States
6. Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle, Washington, United States
7. Division of Pulmonary and Critical Care Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California, United States
8. Center for the Study of Healthcare Innovation, Implementation, and Policy, VA Greater Los Angeles Healthcare System, Los Angeles, California, United States
9. Division of Epidemiology and Biostatistics, School of Public Health, University of Illinois at Chicago, Chicago, Illinois, United States

Address correspondence to:

Stephanie L. LaBedz, MD
Breathe Chicago Center
University of Illinois-Chicago
1220 S. Wood Street, 3^rd Floor
Chicago, IL 60608
Phone: (312) 413-4633
Email: slabedz@uic.edu

Abstract

This article does not contain an abstract.

Citation

Citation: LaBedz SL, Krishnan JA, Chung YC, et al. Chronic obstructive pulmonary disease outcomes at Veterans Affairs versus non-Veterans Affairs hospitals. J COPD F. 2021; 8(3): 306-313. doi: http://doi.org/10.15326/jcopdf.8.3.2021.0201

Keywords

COPD, mortality, readmission, veterans

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Click to read Chronic Obstructive Pulmonary Disease Outcomes at Veterans Affairs Versus Non-Veterans Affairs Hospitals

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Author Affiliations

1. Denver, Colorado

Address correspondence to:

Ron Balkissoon, MD, MSc, DIH, FRCPC
balkissoonr@njhealth.org

Abstract

This article does not contain an abstract.

Citation

Citation: Balkissoon R. Journal club: the intersection of racial/ethnic disparities in coronavirus disease 2019 and COPD. J COPD F. 2021; 8(2): 292-302. doi: http://doi.org/10.15326/jcopdf.8.2.2021.0227

Keywords

COPD, COVID-19, coronavirus disease 2019, chronic obstructive pulmonary diseases, racial/ethnic disparities

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Click to read Journal Club: The Intersection of Racial/Ethnic Disparities in Coronavirus Disease 2019 and COPD

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Author Affiliations

1. Department of Medicine, Columbia University Irving Medical Center, New York, New York, United States
2. Department of Medicine, School of Medicine, University of Virginia, Charlottesville, Virginia, United States
3. Department of Epidemiology, Mailman School of Public Health, Columbia University Irving Medical Center, New York, New York, United States

Address correspondence to:

R. Graham Barr, MD, DrPH
Columbia University Irving Medical Center
Presbyterian Hospital 9 East 105
630 West 168th Street, New York, NY 10032
Email: rgb9@columbia.edu

Abstract

This article does not contain an abstract.

Citation

Citation: Kim JS, Barr RG. Letter to the editor: response by authors. J COPD F. 2021; 8(2): 188-189. doi: http://doi.org/10.15326/jcopdf.8.2.2021.0225

Keywords

There are no keywords for this article.

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Click to read Letter to the Editor: Response by Authors

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Author Affiliations

1. Division of Pulmonary Diseases and Critical Care Medicine, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, United States
2. Gillings School of Global Public Health, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, United States
3. Division of Pulmonary, Critical Care, and Sleep Medicine, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California, United States
4. Departments of Medicine and Physiology, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California, United States
5. Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, Michigan, United States
6. Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine, University of California-San Francisco, San Francisco, California, United States
7. Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine, University of Alabama-Birmingham, Birmingham, Alabama, United States
8. Division of Pulmonary Medicine, University of Utah, Salt Lake City, Utah, United States
9. Division of Pulmonary, Critical Care, and Occupational Medicine, University of Iowa, Iowa City, Iowa, United States
10. Division of Pulmonary, Critical Care, and Sleep Medicine, National Jewish Hospital, Denver, Colorado, United States
11. Division of General Medicine and Clinical Epidemiology, University of North Carolina, Chapel Hill, North Carolina, United States
12. Division of Pulmonary and Critical Care, Johns Hopkins University, Baltimore, Maryland, United States
13. Division of Endocrinology and Metabolism, Johns Hopkins University, Baltimore, Maryland, United States

Address correspondence to:

Robert M. Burkes, MD
231 Albert Sabin Way, ML 0564
Cincinnati, OH 45267
Phone: (724)730-3862
Email: burkesrt@ucmail.uc.edu

Abstract

Introduction: Age and vitamin D levels may affect symptom burden in chronic obstructive pulmonary disease (COPD). We used the Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS) to determine independent associations between vitamin D levels and COPD symptoms in different age strata.

Methods: Serum 25-hydroxy (OH)-vitamin D levels were modeled continuously and categorically (<20 ng/ml versus ≥20 ng/ml). Stratifying by age group (middle-age: 40-64 years old and older: >65 years old), multivariable modeling was performed to identify relationships between 25-OH-vitamin D levels and the COPD Assessment Test (CAT), the modified Medical Research Council score (mMRC), the St George’s Respiratory Questionnaire (SGRQ) total and subdomain scores, the Veterans’ Specific Activity Questionnaire, and the 6-minute walk test distance.

Results: In the middle-aged group, each 5 ng/ml higher 25-OH-vitamin D level was independently associated with more favorable CAT score (-0.35 [-0.67 to -0.03], P=0.03), total SGRQ (-0.91 [-1.65 to -0.17]; P=0.02), and the SGRQ subdomains (Symptoms:-1.07 [-1.96 to -0.18], P=0.02; Impact: -0.77 [-1.53 to -0.003], P=0.049; Activity: -1.07 [-1.96 to -0.18], P=0.02). These associations persisted after the addition of comorbidity score, reported vitamin D supplementation, outdoor time, or season of blood draw to models. No associations were observed between 25-OH-vitamin D levels and symptom scores in the older age group.

Discussion: When controlled for clinically relevant covariates, higher 25-OH-vitamin D levels are associated with more favorable respiratory-specific symptoms and quality-of-life assessments in middle-age but not older COPD individuals. Study of the role of vitamin D supplementation in the symptom burden of younger COPD patients is needed.

Citation

Citation: Burkes RM, Couper DJ, Barjaktarevic IZ, et al.Age-dependent associations between 25-hydroxy vitamin D levels and COPD symptoms: analysis of SPIROMICS. J COPD F. 2021; 8(2): 277-291. doi: http://doi.org/10.15326/jcopdf.8.2.2020.0180

Keywords

COPD, COPD outcomes, vitamin D, COPD epidemiology, COPD symptoms

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Click to read Age-Dependent Associations Between 25-Hydroxy Vitamin D Levels and COPD Symptoms: Analysis of SPIROMICS

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Author Affiliations

1. Department Internal Medicine, Giannitsa Hospital, Giannitsa, Greece
2. Department of Respiratory Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece
3. Department of Respiratory Medicine, G. Papanikolaou Hospital, Thessaloniki, Greece

Address correspondence to:

Afroditi K. Boutou, MD, MSc, PhD
Department of Respiratory Medicine
G. Papanikolaou Hospital
Exohi GR57010
Thessaloniki, Greece
Phone: +30 2313307248
E-mail: afboutou@yahoo.com

Abstract

This article does not contain an abstract.

Citation

Citation: Theodorakopoulou MP, Papakosta D, Kontakiotis T, Boutou AK. Omega-3 fatty acid supplementation for endothelial dysfunction in COPD: another fiasco? Or maybe not? J COPD F. 2021; 8(2): 185-187. doi: http://doi.org/10.15326/jcopdf.8.2.2021.0206

Keywords

COPD, fish-oil, endothelial dysfunction, flow-mediated dilatation, reactive hyperemia index

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Click to read Omega-3 Fatty Acid Supplementation for Endothelial Dysfunction in COPD: Another Fiasco? Or Maybe Not?

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Author Affiliations

1. Research and Development Technology, GlaxoSmithKline, Collegeville, Pennsylvania, United States
2. Research and Development, GlaxoSmithKline, Collegeville, Pennsylvania, United States
3. Department of Physical Medicine and Rehabilitation, Mayo Clinic Rochester, Minnesota, United States
4. Bay Digital Consulting, Hertfordshire, United Kingdom
5. Department of Respiratory Sciences, University of Leicester, Leicester Biomedical Research Centre, Respiratory, Leicester, United Kingdom
6. COPD Foundation, Washington, DC, United States

* Employees of GlaxoSmithKline during the design and conduct of this work.

Address correspondence to:

John Yonchuk, MS
Phone: (610)348-2648
Email: john.g.yonchuk@gsk.com

Abstract

Background: Pulmonary rehabilitation (PR) is an important therapy for patients with chronic obstructive pulmonary disease (COPD), yet uptake remains low. Intervention strategies which recapitulate the benefits of PR are, therefore, needed and digital, home-based therapies present opportunity in this space. Digital therapies also potentially offer an opportunity to standardize PR in clinical trials for new COPD therapies.

Aims and Methods: We aimed to create a digital application (app), Respercise^®, consisting of up to 4 strengthening exercises in conjunction with Therbands™ and a daily physical activity program with individualized step goals, and to test its feasibility in a clinical trial. App usability was surveyed qualitatively before development iterations and deployment in a 13-week interventional clinical trial. All participants who completed the study were invited for an exit interview and performed the 5-repetition sit-to-stand test amongst other measures.

Results: Feedback from clinical trial participants was positive; 97% of respondents liked the app. A total of 88% of participants reported that it was easy to fit the exercises into their daily routine, and there was over 90% adherence for entering daily step counts. Notably, on day 90 both females and males using Respercise alone demonstrated a 2.22- and 2.27-seconds improvement in time for 5-repetition sit-to-stand tests respectively, above the 1.7 second threshold that is considered clinically meaningful in COPD.

Conclusion: Respercise can be successfully deployed in clinical trials, offering the opportunity for standardization of exercise in clinical trials and, with further development, could have wider reach as a home-based intervention for individuals with COPD.

Citation

Citation: Yonchuk JG, Mohan D, LeBrasseur NK, George AR, Singh S, Tal-Singer R. Development of Respercise® a digital application for standardizing home exercise in COPD clinical trials. J COPD F. 2021; 8(2): 269-276. doi: http://doi.org/10.15326/jcopdf.8.2.2020.0194

Keywords

COPD, exercise, clinical trials, physical activity, digital applications, usability

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Click to read Development of Respercise® a Digital Application for Standardizing Home Exercise in COPD Clinical Trials

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Author Affiliations

1. Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, United States
2. Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, United States
3. Department of Radiology, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, United States

Address correspondence to:

Robert M. Marron, MD
Phone: (267) 838-2658
E-mail: robert.marron@tuhs.temple.edu

Abstract

Background: Comorbid disease is a risk factor for severe coronavirus disease 2019 (COVID-19) infection. However, initial rates of chronic obstructive pulmonary disease (COPD) in case series were low and severity of COVID-19 in COPD patients was variable.

Methods: We performed a retrospective study of patients admitted with COVID-19 and evaluated outcomes in those with and without COPD and/or emphysema. Patients were identified as having COPD if they had a diagnosis in the medical record and a history of airflow-obstruction on spirometry, or a history of tobacco use and prescribed long-acting bronchodilator(s). Computed tomography scans were evaluated by radiologists. Propensity matching was performed for age, body mass index (BMI), and serologic data correlated with severity of COVID-19 disease (D-dimer, C-reactive protein, ferritin, fibrinogen, absolute lymphocyte count, lymphocyte percentage, and lactate dehydrogenase).

Results: Of 577 patients admitted with COVID-19, 103 had a diagnosis of COPD and/or emphysema. The COPD/emphysema cohort was older (67 versus 58, p<0.0001) than the other cohort and had a lower BMI. Among unmatched cohorts those with COPD/emphysema had higher rates of intensive care unit (ICU) admission (35% versus 24.9%, p=0.036) and maximal respiratory support requirements, with more frequent invasive mechanical ventilation (21.4% versus 11.8%), but no significant difference in mortality. After propensity-matching there was no difference in ICU admission, maximal respiratory support requirements, or mortality. Univariate and multivariate regression analyses yielded similar results.

Discussion: Our propensity-matched retrospective cohort study suggests that patients hospitalized with COVID-19 who have COPD and/or emphysema may not have worse outcomes than those without these comorbid conditions.

Citation

Citation: Marron RM, Zheng M, Romero GF, et al.Impact of chronic obstructive pulmonary disease and emphysema on outcomes of hospitalized patients with coronavirus 2019 pneumonia. J COPD F. 2021; 8(2): 255-268. doi: http://doi.org/10.15326/jcopdf.8.2.2020.0200

Keywords

COPD, emphysema, chronic obstructive pulmonary disease, comorbidities, COVID-19, outcomes, coronavirus 2019

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Click to read Impact of Chronic Obstructive Pulmonary Disease and Emphysema on Outcomes of Hospitalized Patients with Coronavirus Disease 2019 Pneumonia

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Author Affiliations

1. College of Public Health, University of Kentucky, Lexington, Kentucky, United States
2. COPD Foundation, Washington, DC, United States
3. School of Public Health, Rutgers University, Piscataway, New Jersey, United States
4. Pulmonary Disease and Critical Care Medicine, Mayo Clinic, Rochester, Minnesota, United States

Address correspondence to:

Vira Pravosud, MPH, MS
College of Public Health
Department of Epidemiology
University of Kentucky
111 Washington Avenue, Room 211C
Lexington, KY 40536
Email: vira.pravosud@uky.edu

Abstract

Purpose: Respiratory diseases caused by nontuberculous mycobacteria (NTM) have become a significant concern for patients and health care providers. We aimed to compare symptoms experienced during the 2 week period, at a single point in time, by patients with NTM lung disease (NTMLD) who were currently on any medication to treat their NTMLD versus those not on any therapies.

Methods: We analyzed responses to a “Burden of NTM Survey” developed by the COPD Foundation. The study population included 266 individuals with NTMLD. Using adjusted penalized logistic regression models, we determined associations between the self-reported symptoms and the use of any medication to treat NTMLD.

Results: Based on available data, most respondents were aged 50 and older (95.1%), of female gender (93.1%), and had been living with NTMLD for more than 5 years (55.7%). Many respondents reported symptoms that bother them very often or daily. After adjustment for age and gender, duration of living with NTMLD, and other respiratory illnesses, patients on medication had significantly larger odds of reporting difficulty in walking 500 meters without stopping, difficulty in interacting with others, fatigue or lack of energy, feelings of sadness or depression related to illness, and shortness of breath, wheezing or other difficulties.

Conclusion: In this study, patients currently on any medication to treat their NTMLD reported more symptoms associated with their NTMLD. Further investigations are needed to explore whether increased symptoms are related to differences in disease severity and/or medication effects.

Citation

Citation: Pravosud V, Mannino DM, Prieto D, et al. Symptom burden and medication use among patients with nontuberculous mycobacterial lung disease. J COPD F. 2021; 8(2): 243-254. doi: http://doi.org/10.15326/jcopdf.8.2.2020.0184

Keywords

NTM, nontuberculous mycobacteria, nontuberculous mycobacterial lung disease, NTMLD, BronchandNTM360social, Burden of NTM Survey

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Click to read Symptom Burden and Medication Use Among Patients with Nontuberculous Mycobacterial Lung Disease

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Author Affiliations

1. Weill Cornell Medicine, New York Presbyterian Hospital, New York, New York, United States
2. Columbia University, New York Presbyterian Hospital, New York, New York, United States
3. PRIME Education, LLC, Fort Lauderdale, Florida, United States
4. University of Michigan Health System, Ann Arbor, Michigan, United States

Address correspondence to:

Fernando J. Martinez, MD, MS
1305 York Ave
Box 96, Room Y-1059
New York, NY 10021
Phone: 646.962.2748
Email: fjm2003@med.cornell.edu

Abstract

Introduction: Recommendations for chronic obstructive pulmonary disease (COPD) diagnosis and management requires symptom and exacerbation risk assessment. Adherence to these recommendations appears to be limited. We examined the impact of a COPD quality improvement (QI) program in the Southeastern United States.

Methods: From 2017 to 2018, nine pulmonary and 15 primary care physicians were included in our study and asked to identify 6 to 7 of their COPD patients using maintenance COPD medications with at least 2 office visits in the past year. A separate group of COPD patients (n=135 pulmonary and 165 primary care) from the same practices were evaluated. Physicians underwent focused, educational, peer-to-peer small group webinars. Data were collected from physicians and their patients using a systematic survey. Chart audits occurred at baseline and 6 months after the webinars.

Results: The majority of physicians (67%) saw ≥ 20 COPD patients/week. There were important discrepancies between the care clinicians thought they provided, and the care recalled by their patients. Clinicians felt that 33% of their patients experienced at least 2 exacerbations in the past year; 56% of their patients reported this frequency. There was discrepancy in the clinicians’ interpretations and the patients’ reasons for discontinuing their medications and in the use of referrals. Self-reported changes were noted by clinicians after educational webinars and improvements in patient care were noted in the year following intervention.

Conclusion: We identified notable discrepancies between the clinicians’ impression of care provided and the components actually recalled by their patients. We also identified improvements in processes of care and outcomes following an educational intervention based on the principles of audit and feedback.

Citation

Citation: Martinez FJ, Thomashow B, Sapir T, Simone L, Carter J, Han M. Does evaluation and management of COPD follow therapeutic strategy recommendations? J COPD F. 2021; 8(2): 230-242. doi: http://doi.org/10.15326/jcopdf.8.2.2020.0175

Keywords

COPD, adherence, evaluation, therapeutic strategy

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Click to read Does Evaluation and Management of COPD Follow Therapeutic Strategy Recommendations?

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Author Affiliations

1. Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania, United States
2. Department of Clinical Sciences, Temple Clinical Research Institute, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania, United States
3. Department of Pulmonary, Critical Care, and Sleep Medicine, University of California, San Diego, California, United States

*student

Address correspondence to:

Samuel L. Krachman, DO
Lewis Katz School of Medicine at Temple University
3401 North Broad St.
Philadelphia, PA 19140
Phone: (215) 707-4678
E-mail: samuel.krachman@tuhs.temple.edu

Abstract

Background: Factors responsible for poor sleep quality in patients with chronic obstructive pulmonary disease (COPD) includes the effects of medications. This study evaluates the effect of the inhaled triple therapy of budesonide-formoterol-tiotropium versus placebo-tiotropium on sleep quality in COPD patients.

Methods: Twenty-three patients (11 [48%] males; age 55 [51–60, 48-–5] years; body mass index [BMI] 25 [22–30, 18-40] kg/m²; forced expiratory volume in 1 second [FEV₁]1.10 [0.80 –1.90, 0.60–2.80] L, 42 [31–62, 24–75] % predicted) were studied. Ten patients were randomized to budesonide-formoterol-tiotropium and 13 patients to placebo-tiotropium. At baseline and after 28 days, patients completed spirometry, polysomnography, an Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), COPD-specific St George’s Respiratory Questionnaire (SGRQ-C) and short form 36 (SF 36).

Results: After 28 days, there was a significant 29% increase in the bedtime FEV₁ in the budesonide-formoterol-tiotropium group (from 0.75 [0.55–1.30, 0.50–2.40] L to 1.00 [0.75–1.55, 0.50–3.00] L, p=0.031), with no change in the placebo-tiotropium group (from 1.20 [0.80–1.50, 0.60–1.90] L to 1.15 [0.75–1.55, 0.50–1.80] L, p=0.91). No significant change was found post treatment in sleep efficiency or total sleep time in both the budesonide-formoterol-tiotropium group (from 78 [72-92, 62-98]% to 88 [77-92, 40-98]%, p=0.70 and 290 [268-358, 252-382] min to 342 [303-358, 157-372] min, p=0.77, respectively) and the placebo-tiotropium group (from 82 [75–88, 46–93]% to 84 [77–87, 62–94]%, p=0.96 and 320 [292–350, 180–378] min to 339 [303–349, 241–366] min, p=0.79, respectively). While there was no significant change in the arousal index in the budesonide-formoterol-tiotropium group (9 [5–16, 0–48] arousals/hour to 14 [9–17, 2-36] arousals/hour, p=0.43), a significant increase was seen in the placebo-tiotropium group (11 [4–13, 3-–2] arousals/hour to 17 [11–21, 2–33] arousals/hour, p=0.027). Similarly, there was no change in the ESS in the budesonide-formoterol-tiotropium group (6 [3–8, 0–11] to 6 [5–8, 0–1]), p=0.44), but a marginally significant increase in the placebo-tiotropium group (8 [5–12, 2–18] to 10 [7­13, 5­18], p=0.07), with a significant difference in the ESS 28 days post treatment between the 2 groups (6 [5-8, 0-11] versus 10 [7-13, 5-18], p=0.043). There was no significant change in nocturnal oxygenation, sleep architecture, PSQI, SGRQ-C, or SF 36 in both groups.

Conclusion: In patients with COPD, inhaled triple therapy with budesonide-formoterol-tiotropium as compared to placebo-tiotropium improves pulmonary function while preserving sleep quality and architecture.

Citation

Citation: Krachman SL, Vega ME, Yu D, et al. Effect of triple therapy with budesonide-formoterol-tiotropium versus placebo-tiotropium on sleep quality in patients with chronic obstructive pulmonary disease. J COPD F. 2021; 8(2): 219-229. doi: http://doi.org/10.15326/jcopdf.8.2.2020.0178

Keywords

COPD, emphysema, sleep quality, nocturnal oxygen desaturation

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