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. Chronic Obstr Pulm Dis. 2021; 8(4): 414-426. doi: http://dx.doi.org/10.15326/jcopdf.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. 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 Chronic Obstr Pulm Dis. 2021; 8(4): 427-440. doi: http://dx.doi.org/10.15326/jcopdf.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. 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. Chronic Obstr Pulm Dis. 2021; 8(4): 441-449. doi: http://dx.doi.org/10.15326/jcopdf.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. 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. Chronic Obstr Pulm Dis. 2021; 8(4): 450-463. doi: http://dx.doi.org/10.15326/jcopdf.2021.0224

Keywords

roflumilast, azithromycin, OPD exacerbation

Full Text

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

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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. Chronic Obstr Pulm Dis. 2021; 8(4): 464-473. doi: http://dx.doi.org/10.15326/jcopdf.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. 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. Chronic Obstr Pulm Dis. 2021; 8(4): 474-487. doi: http://dx.doi.org/10.15326/jcopdf.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. 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. Chronic Obstr Pulm Dis. 2021; 8(4): 488-501. doi: http://dx.doi.org/10.15326/jcopdf.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. 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. Chronic Obstr Pulm Dis. 2021; 8(4): 502-516. doi: http://dx.doi.org/10.15326/jcopdf.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. Chronic Obstr Pulm Dis. 2021; 8(4): 517-527. doi: http://dx.doi.org/10.15326/jcopdf.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. 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. Chronic Obstr Pulm Dis. 2021; 8(4): 528-550. doi: http://dx.doi.org/10.15326/jcopdf.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. Chronic Obstr Pulm Dis. 2021; 8(4): 551-571. doi: http://dx.doi.org/10.15326/jcopdf.2021.0235

Keywords

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

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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. Chronic Obstr Pulm Dis. 2021; 8(4): 572-579. doi: http://dx.doi.org/10.15326/jcopdf.2021.0234

Keywords

COPD, exacerbations, COVID-19

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