Author Affiliations

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

Address correspondence to:

Alexander G. Duarte, MD
Division of Pulmonary, Critical Care and Sleep Medicine
University of Texas Medical Branch
301 University Blvd., 5.140 John Sealy Annex
Galveston, Texas 77555-0561
Email: aduarte@utmb.edu

Abstract

Objectives: Determine the prevalence of suboptimal peak inspiratory flow rate (PIFR) and associated patient characteristics and compare PIFR measurements obtained with spirometry and In-Check DIAL^® device in ambulatory patients with COPD.

Methods: Patients underwent PIFR measurement with In-Check DIAL^® device and pulmonary function testing with calibrated equipment. Group characteristics and lung function were compared for patients with suboptimal (≤ 60 L/min) and optimal (> 60 L/min) PIFR. Receiver operating curve analysis determined the best maximal forced inspiratory flow (FIF max) value in identifying optimal PIFR by gender and height.

Results: From July 1, 2016 to January 31, 2018, a total of 303 patients with chronic obstructive pulmonary disease (COPD) had PIFR and pulmonary function measurements. Group mean age was 65.5 ± 11.3 years with equal gender distribution. Suboptimal PIFR was observed in 61 (20.1%) patients. A significant correlation was observed between PIFR and FIF max, inspiratory capacity and residual volume (RV) to total lung capacity (TLC) ratio.

In the suboptimal PIFR group, mean FIF max measured by spirometry was significantly less compared with the optimal PIFR group; 178.5 ± 56.9 L/min and 263.4 ± 89.9 L/min, respectively (p<0.0001). Receiver operator curve analysis of FIF max to identify an optimal PIFR yielded an area under the curve of 0.79. Males < 65 inches had a suboptimal PIFR in 16.7 % of the male cohort, while females < 65 inches had a suboptimal PIFR in 27.4 % of the women.

Conclusions: Suboptimal PIFR was present in 1 in 5 stable patients with COPD and was more frequent in short statured females. Spirometry determined FIF max was associated with PIFR based on gender and height.

Citation

Citation: Duarte AD, Tung L, Zhang W, Hsu ES, Kuo Y-F, Sharma G. Spirometry measurement of peak inspiratory flow identifies suboptimal use of dry powder inhalers in ambulatory patients with COPD. J COPD F. 2019; 6(3): 246-255. doi: http://doi.org/10.15326/jcopdf.6.3.2018.0163

Keywords

COPD, chronic obstructive pulmonary disease, peak inspiratory flow rate, inhalation therapy, dry powder inhaler, pulmonary function test

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Click to read Spirometry Measurement of Peak Inspiratory Flow Identifies Suboptimal Use of Dry Powder Inhalers in Ambulatory Patients with COPD

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Author Affiliations

1. Division of Pulmonary Medicine National Jewish Health, Denver, Colorado
2. School of Public Health, University of Colorado, Denver
3. Division of Cardiology, Harbor-University of California-Los Angeles Medical Center, Los Angeles
4. Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor
5. Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland
6. Pulmonary and Critical Care Medicine, Ann Arbor Healthcare System, Ann Arbor, Michigan
7. Edinburgh Imaging, Queen’s Medical Research Institute, University of Edinburgh, Edinburgh, Scottland
8. Channing Division of Network Medicine, Brigham Women’s Hospital, Boston, Massachusetts

Address correspondence to:

Elizabeth A. Regan, MD, PhD
National Jewish Health
1400 Jackson St, K706
Denver, CO 80206
ReganE@NJHealth.org
Phone: 303-398-1531

Abstract

Background: Lung cancer screening (LCS) via chest computed tomography (CT) scans can save lives by identifying early-stage tumors. However, most smokers die of comorbid smoking-related diseases. LCS scans contain information about smoking-related conditions that is not currently systematically assessed. Identifying these common comorbid diseases on CT could increase the value of screening with minimal impact on LCS programs. We determined the prevalence of 3 comorbid diseases from LCS eligible scans and quantified related adverse outcomes.

Methods: We studied COPD Genetic Epidemiology study (COPDGene^®) participants (n=4078) who met criteria for LCS screening at enrollment (age > 55 years, and < 80 years, > 30 pack years smoking, current smoker or former smoker within 15 years of smoking cessation). CT scans were assessed for coronary artery calcification (CAC), emphysema, and vertebral bone density. We tracked the following clinically significant events: myocardial infarctions (MIs), strokes, pneumonia, respiratory exacerbations, and hip and vertebral fractures.

Results: Overall, 77% of eligible CT scans had one or more of these diagnoses identified. CAC (> 100 mg) was identified in 51% of scans, emphysema in 44%, and osteoporosis in 54%. Adverse events related to the underlying smoking-related diseases were common, with 50% of participants reporting at least one. New diagnoses of cardiovascular disease, emphysema and osteoporosis were made in 25%, 7% and 46%, of participants respectively. New diagnosis of disease was associated with significantly more adverse events than in participants who did not have CT diagnoses for both osteoporosis and cardiovascular risk.

Conclusions: Expanded analysis of LCS CT scans identified individuals with evidence of previously undiagnosed cardiovascular disease, emphysema or osteoporosis that corresponded with adverse events. LCS CT scans can potentially facilitate diagnoses of these smoking-related diseases and provide an opportunity for treatment or prevention.

Citation

Citation: Regan EA, Lowe KE, Make BJ, et al and the COPDGene investigators. Identifying smoking-related disease on lung cancer screening CT scans: increasing the value. J COPD F. 2019; 6(3): 233-245. doi: http://doi.org/10.15326/jcopdf.6.3.2018.0142

Keywords

COPD, chronic obstructive pulmonary disease, comorbidities, lung cancer screenings, smoking-related disease

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Click to read Identifying Smoking-Related Disease on Lung Cancer Screening CT Scans: Increasing the Value

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Author Affiliations

1. Division of Pulmonary, Allergy, and Critical Care Medicine, Columbia University, New York
2. Division of Pulmonary, Critical Care and Sleep Medicine, National Jewish Health, Denver, Colorado
3. Division of Pulmonary Diseases and Critical Medicine, Department of Medicine, University of North Carolina, Chapel Hill
4. Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor
5. Asthma and COPD Program, Northwestern University Feinberg School of Medicine, Chicago, Illinois
6. COPD Foundation, Washington, D.C.
7. GlaxoSmithKline, Philadelphia, Pennsylvania and Department of Preventative Medicine and Environmental Health University of Kentucky, College of Public Health, Lexington
8. Early Clinical Development, IMED Biotech Unit, AstraZeneca, Cambridge, United Kingdom and Department of Medicine, University of Nebraska Medical Center, Omaha
9. Division of Pulmonary Allergy and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
10. Pulmonary and Critical Care, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland

Address correspondence to:

Byron Thomashow, MD
Email: bmt1@cumc.columbia.edu
Phone: (212)305-5261

Abstract

The COPD Foundation has tried to address gaps in chronic obstructive pulmonary disease (COPD) care by providing COPD Pocket Consultant Guide cards to U.S. health care providers. Since launching the card in 2007, there have been numerous updates and more than 800,000 of these cards have been distributed at no charge to health care professionals. The most recent versions have concentrated on presenting an algorithm for COPD management based on 7 severity domains: spirometry, symptoms, exacerbations, oxygen requirements, the presence of chronic bronchitis or emphysema and comorbidities. To increase the usability and reach of this tool, the COPD Pocket Consultant Guide is now available as an app for iOS and Android. This updated version of the app includes new COPD and asthma/COPD overlap flow charts; an interactive therapy chart that takes into account modified Medical Research Council (mMRC), COPD Assessment Test (CAT), and spirometry scores; anxiety and depression screeners; up-to-date medication charts in both brand and generic formats; a checklist to aid in determining when a patient should be referred to a pulmonologist and more. Potential use of the COPD Pocket Consultant Guide app in clinical care is discussed.

Citation

Citation: Thomashow B, Crapo JD, Drummond MB, et al. Introducing the new COPD Pocket Consultant Guide app: can a digital approach improve care? A statement of the COPD Foundation. J COPD F. 2019; 6(3): 210-220. doi: http://doi.org/10.15326/jcopdf.6.3.2018.0167

Keywords

COPD, chronic obstructive pulmonary disease, exacerbations, acute exacerbation of COPD, AECOPD, depression, Pocket Consultant Guide, app, management, maintenance, medication, anxiety

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Click to read Introducing the New COPD Pocket Consultant Guide App: Can A Digital Approach Improve Care? A Statement of the COPD Foundation

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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 - bronchiectasis/COPD overlap: syndrome versus treatable trait? J COPD F. 2019; 6(2): 193-199. doi: http://doi.org/10.15326/jcopdf.6.2.2019.0134

Keywords

COPD, chronic obstructive pulmonary disease, bronchiectasis, overlap syndrome

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Click to read Journal Club - Bronchiectasis/COPD Overlap: Syndrome Versus Treatable Trait?

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Author Affiliations

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

Address correspondence to:

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

Abstract

This article does not contain an abstract.

Citation

Citation: Marron RM, Vega Sanchez ME. Images in COPD: asthma-COPD overlap syndrome. J COPD F. 2019; 6(2): 200-202. doi: http://doi.org/10.15326/jcopdf.6.2.2018.0169

Keywords

COPD, chronic obstructive pulmonary disease, asthma-COPD overlap syndrome, ACOS, high-resolution computed tomography, CT densitometry

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Click to read Asthma-COPD Overlap Syndrome

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Author Affiliations

1. Division of Pulmonary, Critical Care, Allergy and Sleep Medicine, Medical University of South Carolina, Charleston

Address correspondence to:

Charlie Strange, MD
Division of Pulmonary, Critical Care, Allergy and Sleep Medicine
Medical University of South Carolina
MSC630, 96 Jonathan Lucas St
Charleston, SC, 29425
Email:strangec@musc.edu
Phone: 843-792-3174

Abstract

This article does not contain an abstract.

Citation

Citation: Strange C. Rare disease registries: steps forward. J COPD F. 2019; 6(2): 126-128. doi: http://doi.org/10.15326/jcopdf.6.2.2019.0133

Keywords

alpha-1 antitrypsin deficiency, bronchiectasis, registry, ciliary, immunodeficiency

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Click to read Rare Disease Registries: Steps Forward

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Author Affiliations

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

Address correspondence to:

Yaniv Dotan, MD, PhD
Department of Thoracic Medicine and Surgery
Temple University Hospital
3401 N Broad Street
Philadelphia, PA 19140
Email: Yaniv.dotan@sluhn.org
Phone:(484)795-6446

Abstract

This article does not contain an abstract.

Citation

Citation: Dotan Y, So JY, Kim V. Chronic bronchitis: where are we now? J COPD F. 2019; 6(2): 178-192. doi: http://doi.org/10.15326/jcopdf.6.2.2018.0151

Keywords

COPD, chronic bronchitis, chronic obstructive pulmonary disease, cigarette smoking

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Click to read Chronic Bronchitis: Where Are We Now?

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Author Affiliations

1. Pulmonary Research Institute of Southeast Michigan, Farmington Hills
2. South Carolina Pharmaceutical Research, Spartanburg
3. Sherman Clinical Research, Sherman, Texas
4. Theravance Biopharma US, Inc., South San Francisco, California

Address correspondence to:

Gary T. Ferguson, MD
Suite A
29255 West 10 Mile Road
Farmington Hills, MI 48336
Email: garytferguson@msn.com
Phone: (248) 478-6561

Abstract

Background: Revefenacin, a novel, lung-selective, long-acting muscarinic antagonist, has been developed for nebulized therapy for chronic obstructive pulmonary disease (COPD). We present the results of replicate Phase III efficacy and safety studies of revefenacin in patients with moderate to very severe COPD.

Methods: In 2 double-blind, parallel-group studies, (Study 0126 and Study 0127), patients ≥ 40 years old were randomized to revefenacin 88 μg, revefenacin 175 μg or placebo administered once daily by standard jet nebulizer for 12 weeks. The primary endpoint was 24-hour trough forced expiratory volume in 1 second (FEV₁) on day 85. Secondary efficacy endpoints included overall treatment effect (OTE) on trough FEV₁ and peak FEV₁ (0-2 hours after first dose). Safety assessments included treatment-emergent adverse events.

Results: At day 85, revefenacin 88 µg and 175 µg improved trough FEV₁ versus placebo in Study 0126 (by 79 mL [p=0.0003] and 146 mL [p<0.0001]) and Study 0127 (by 160 mL and 147 mL; both p<0.0001). Compared with placebo, pooled data of revefenacin 88 µg and 175 µg increased OTE trough FEV₁ by 115 mL and 142 mL (both p<0.001) and increased peak FEV₁ by 127 mL and 129 mL (both p<0.0001). Revefenacin 175 µg demonstrated greater improvements in FEV₁ in concomitant long-acting beta2-agonist patients and in more severe patients than revefenacin 88 µg. Adverse events were minor.

Conclusions: Revefenacin, administered once daily for 12 weeks to patients with moderate to very severe COPD, demonstrated clinically significant improvements in trough FEV₁ and OTE FEV₁. Revefenacin was generally well tolerated with no major safety concerns.

Citation

Citation: Ferguson GT, Feldman G, Pudi KK, et al. Improvements in lung function with nebulized revefenacin in the treatment of patients with moderate to very severe COPD: results from two replicate phase III clinical trials. J COPD F. 2019; 6(2): 154-165. doi: http://doi.org/10.15326/jcopdf.6.2.2018.0152

Keywords

COPD, chronic obstructive pulmonary disease, forced expiratory volume in 1 second, FEV₁, Revefenacin, nebulized therapy, Phase III randomized controlled trial

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Click to read Improvements in Lung Function with Nebulized Revefenacin in the Treatment of Patients with Moderate to Very Severe COPD: Results from Two Replicate Phase III Clinical Trials

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Author Affiliations

1. Icahn School of Medicine Mt Sinai, New York, New York
2. University of Kentucky College of Public Health, Lexington
3. Oregon Health Sciences University Hospital, Portland
4. New York University School of Medicine, New York
5. Pulmonary Disease and Critical Care Medicine, Mayo Clinic, Rochester, Minnesota
6. Division of Mycobacterial and Respiratory Infections, National Jewish Health, Denver, Colorado
7. University of North Carolina at Chapel Hill
8. Columbia College of Physicians and Surgeons, Center for Chest Disease, New York, New York
9. National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland
10. University of Texas at Tyler
11. Mayo Clinic Florida, Pulmonary and Critical Care, Jacksonville
12. Division of Pulmonary and Critical Care Medicine, University of Connecticut School of Medicine, Farmington
13. Georgetown University Medical Center, Washington, DC
14. University of Kansas Medical School, Kansas City
15. University of Miami Miller School of Medicine, Miami, Florida
16. University of Pennsylvania Perelman School of Medicine, Philadelphia
17. Department of Infectious Disease, Oregon Health and Science University School of Medicine, Portland

Address correspondence to:

Edward Eden, MBBS
Division of Pulmonary, Critical Care and Sleep Medicine
Mt Sinai West, Room # 3A-55
1000 10^th Avenue
New York, NY 10019
Phone: 212-523-7341
Email: edward.eden@mountsinai.org

Abstract

Objective: This study compares and contrasts the clinical features of non-cystic fibrosis bronchiectasis with 3 uncommon disorders known to be associated with bronchiectasis but with distinctly different underlying defined pathophysiologic derangements, namely severe alpha-1 antitrypsin deficiency (AATD), common variable immunodeficiency (CVI) and primary ciliary dyskinesia (PCD).

Methods: The Bronchiectasis Research Registry provides a central database for studying patients with non-cystic fibrosis bronchiectasis. This report consists of information from 13 U.S. sites pertaining to the 3 study diagnoses. Patients with AATD (SZ and ZZ phenotypes only), CVI (patients with IgG≤500), PCD (history of physician diagnosed Kartagener’s syndrome or PCD), and patients with confirmed absence of the above 3 diagnoses (idiopathic control group) were included in the study. Descriptive statistics were computed for the main demographic and clinical characteristics of the sample stratified by group. Values between the groups were compared using Kruskal-Wallis test, and Chi-squared/ Fisher’s exact tests respectively. The significance level was set at 0.05. Software SAS 9.4 was used to perform the statistical analyses.

Results: Of the 2170 participants in the database enrolled as of January 2017, 615 respondents had sufficient data and were included in the analyses. Patients with PCD (n=79, mean age 41.9 years [standard deviation (SD)=14.5]) were significantly younger than patients with AATD (n=58, mean age 66.9 [SD=10.7]), CVI (n=18, mean age 66.7 years [SD=10.5]) or the idiopathic group (n=460, mean age 64.2 [SD=15.9]), p<.0001. Compared to other groups, those with PCD had lower pulmonary function (forced expiratory volume in 1 second [FEV₁] forced vital capacity [FVC] and FEV1/FVC ratio) (p<0.01), and a greater proportion of them reported having exacerbations and/or hospitalizations in the past 2 years (p<0.01). Overall, Pseudomonas aeruginosa and Staphylococcus aureus were the organisms most commonly isolated from sputum. Mycobacterial infection was most commonly reported in those with AATD.

Conclusions: This report from the U.S. Bronchiectasis Research Registry compares and contrasts differences in the clinical features of patients suffering from 3 rare conditions, with different underlying causes, to those without. The group with PCD had more symptoms, greater morbidity, lower lung function and more commonly were infected by Pseudomonas aeruginosa. A greater percentage of those with AATD reported mycobacterial lung involvement.

Citation

Citation: Eden E, Choate R, Barker A, et al. The clinical features of bronchiectasis associated with alpha-1 antitrypsin deficiency, common variable immunodeficiency and primary ciliary dyskinesia--results from the U.S. Bronchiectasis Research Registry. J COPD F. 2019; 6(2): 145-153. doi: http://doi.org/10.15326/jcopdf.6.2.2018.0156

Keywords

alpha-1 antitrypsin deficiency, bronchiectasis, Bronchiectasis Research Registry, common variable immunodeficiency, primary ciliary dyskinesia

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Click to read The Clinical Features of Bronchiectasis Associated with Alpha-1 Antitrypsin Deficiency, Common Variable Immunodeficiency and Primary Ciliary Dyskinesia--Results from the U.S. Bronchiectasis Research Registry

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Author Affiliations

1. CIRO, Center of Expertise for Chronic Organ Failure, Horn, The Netherlands
2. Department of Respiratory Medicine, Maastricht University Medical Center, Maastricht, The Netherlands
3. Centre of Expertise for Palliative Care, Maastricht University Medical Center, Maastricht, The Netherlands
4. COPD Center, Sahlgrenska University Hospital and Institute of Medicine, Gothenburg University, Gothenburg, Sweden

Address correspondence to:

Dr. Sarah Houben-Wilke
Hornerheide 1
6085 NM Horn
The Netherlands
Email: sarahwilke@ciro-horn.nl
Phone: +31 (0)475 587 602

Abstract

Beyond respiratory impairment, patients with chronic obstructive pulmonary disease (COPD) often suffer from comorbidities which are associated with worse health status, higher health care costs and worse prognosis. Reported prevalences of comorbidities largely differ between studies which might be explained by different assessment methods (objective assessment, self-reported assessment, or assessment by medical records), heterogeneous study populations, inappropriate control groups, incomparable methodologies, etc. This narrative review demonstrates and further evaluates the variability in prevalence of several comorbidities in patients with COPD and control individuals and discusses several shortcomings and pitfalls which need to be considered when interpreting comorbidity data. Like in other chronic organ diseases, the accurate diagnosis and integrated management of comorbidities is a key for outcome in COPD. This review highlights that there is a need to move from the starting point of an established index disease towards the concept of the development of multimorbidity in the elderly including COPD as an important and highly prevalent pulmonary component.

Citation

Citation: Houben-Wilke S, Triest FJJ, Franssen FME, Janssen DJA, Wouters EFM, Vanfleteren LEGW. Revealing methodological challenges in chronic obstructive pulmonary disease studies assessing comorbidities: a narrative review. J COPD F. 2019; 6(2): 166-177. doi: http://doi.org/10.15326/jcopdf.6.2.2018.0145

Keywords

COPD, chronic obstructive pulmonary disease, comorbidity, multimorbidity, methodology, bias, control group

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Click to read Revealing Methodological Challenges in Chronic Obstructive Pulmonary Disease Studies Assessing Comorbidities: A Narrative Review

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Author Affiliations

1. Division of Pulmonary, Critical Care, and Sleep Medicine, Icahn School of Medicine at Mount Sinai, New York, New York
2. Institute for Health Care Delivery Science at Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York

Address correspondence to:

Sidney Braman, MD
Division of Pulmonary, Critical Care & Sleep Medicine
Icahan School of Medicine at Mount Sinai
5th Floor, Rm 5-20
Annenberg Bldg
1468 Madison Avenue
New York, NY 10029
Email: sidney.braman@mssm.edu

Abstract

We evaluated whether visiting a primary care provider (PCP) or medical subspecialist within 10 days of discharge reduces 30-day readmissions following hospitalization for acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Data were retrospectively collected from electronic health records for AECOPD-related hospitalizations at an urban, academic medical center for patients 40 years of age or older between June 2011 and June 2016. Primary outcome was probability of all-cause 30-day readmission. Follow-up was defined as visiting a PCP or any medical subspecialist within 10 days of discharge. Generalized linear mixed models were used to examine the association between hospital readmissions and a visit to a PCP or medical subspecialist. Of the 2653 hospital discharges, 17.6% (n=468) had a 30-day readmission. Follow-up did not affect 30-day readmission risk (adjusted odds ratio 1.14; 95% confidence interval 0.89, 1.47). Prompt follow-up is not associated with a reduced risk of 30-day readmission following AECOPD, highlighting the need for a comprehensive approach to chronic obstructive pulmonary disease (COPD).

Citation

Citation: Budde J, Agarwal P, Mazumdar M, Braman SS. Follow-up soon after discharge may not reduce COPD readmissions. J COPD F. 2019; 6(2): 129-131. doi: http://doi.org/10.15326/jcopdf.6.2.2018.0149

Keywords

COPD, chronic obstructive pulmonary disease, hospital readmissions, acute exacerbation of COPD, AECOPD, physician follow-up, health care delivery

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Click to read Follow-up Soon After Discharge May Not Reduce COPD Readmissions

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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: endobronchial valve bronchoscopic lung volume reduction. J COPD F. 2019; 6(1): 118-125. doi: http://doi.org/10.15326/jcopdf.6.1.2019.0126

Keywords

COPD, emphysema, chronic obstructive pulmonary disease, lung volume reduction, endobronchial valve

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Click to read Journal Club: Endobronchial Valve Bronchoscopic Lung Volume Reduction

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Author Affiliations

1. St Francis Hospital and University Medical Research, LLC

Address correspondence to:

Nicholas Gross, MD, PhD
Grossnicholas1@gmail.com

Abstract

This article does not contain an abstract.

Citation

Citation: Gross N. COPD pipeline XXXX. Chronic Obstr Pulm Dis. J COPD F. 2019; 6(1): 115-117. doi: http://doi.org/10.15326/jcopdf.6.1.2018.0165

Keywords

Gala Airway, MyCOPD, dual orexin receptor antagonist, triple therapy

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Click to read The COPD Pipeline XXXX

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Author Affiliations

1. Education Institute, Cleveland Clinic, Cleveland, Ohio

Address correspondence to:

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

Abstract

This article does not contain an abstract.

Citation

Citation: Stoller JK. Editorial. Progress in alpha-1 antitrypsin deficiency: collaboration as the foundation of new knowledge. J COPD F. 2019; 6(1): 1-5. doi: http://doi.org/10.15326/jcopdf.6.1.2018.0164

Keywords

chronic obstructive pulmonary disease, alpha-1 antitrypsin deficiency

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Click to read Progress in Alpha-1 Antitrypsin Deficiency: Collaboration as the Foundation of New Knowledge

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Author Affiliations

1. Department of Internal Medicine, University of Michigan, Ann Arbor
2. Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor
3. Division of Pulmonary Medicine, National Jewish Health, Denver, Colorado
4. Division of Pulmonary and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
5. Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego
6. Division of Pulmonary, Allergy and Critical Care Medicine, University of Alabama, Birmingham
7. School of Public Health, University of Michigan, Ann Arbor
8. School of Public Health, University of Colorado, Aurora
9. Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts
10. Veterans’ Administration Ann Arbor Healthcare System, Ann Arbor, Michigan

Address correspondence to:

MeiLan Han, MD, MS
Division of Pulmonary and Critical Care Medicine
3916 Taubman Center
1500 E. Medical Center Drive
University of Michigan Medical Center
Ann Arbor, MI 48109-0360
Phone: 734-763-2540
Email: Mrking@med.umich.edu

Abstract

Background: The Global initiative for chronic Obstructive Lung Disease (GOLD) ABCD groupings were recently modified. The GOLD 2011 guidelines defined increased risk as forced expiratory volume in 1 second (FEV₁) < 50% predicted or ≥ 2 outpatient or ≥ 1 hospitalized exacerbation in the prior year, whereas the GOLD 2017 guidelines use only exacerbation history. We compared mortality and exacerbation rates in the Genetic Epidemiology of COPD Study cohort (COPDGene^®) by 2011 (exacerbation history/FEV₁ and dyspnea) versus 2017 (exacerbations and dyspnea) classifications.

Methods: Using data from COPDGene^®, we tested associations of ABCD groups with all-cause mortality (Cox models, adjusted for age, sex, race and comorbidities) and longitudinal exacerbations (zero-inflated Poisson models).

Results: In 4469 individuals (mean age 63.1 years, 44% female), individual distributions in 2011 versus 2017 systems were: A, 32.0% versus 37.0%; B, 17.6% versus 36.3%; C, 9.4% versus 4.4%; D, 41.0% versus 22.3%; (observed agreement 76% [expected 27.8%], Kappa 0.67, p<0.001). Individuals in group D-2011 had 1.1 ± 1.6 exacerbations/year (mean ± standard deviation [SD]) versus 1.4 ± 1.8 for D-2017 (median follow-up 3.7 years). Using group A as reference, for both systems, mortality (median follow-up 6.8 years) was highest in group D (D-2011, [hazard ratio] HR 5.2 [95% confidence interval (CI) 4.2, 6.4]; D-2017, HR 5.5 [4.5, 6.8]), lowest for group C (HR 1.9 [1.4, 2.6] versus HR 1.9 [1.3, 2.8]) and intermediate for group B (HR 2.6 [2.0, 3.4] versus HR 3.4 [2.8, 4.1]). GOLD 2011 had better mortality discrimination (area under the curve [AUC] 0.68) than GOLD 2017 (AUC 0.66, p<0.001 for comparison) but similar exacerbation rate prediction.

Conclusions: Relative to the GOLD 2011 consensus statement, discriminate predictive power of the 2017 ABCD classification is similar for exacerbations but lower for survival.

Citation

Citation: Criner RN, Labaki WW, Regan EA, et al; for the COPDGene Investigators. Mortality and exacerbations by Global Initiative for Chronic Obstructive Lung Disease Groups ABCD: 2011 versus 2017 in the COPDGene® Cohort. J COPD F. 2019; 6(1): 64-73. doi: http://doi.org/10.15326/jcopdf.6.1.2018.0130

Keywords

COPD, chronic obstructive pulmonary disease, Global initiative for chronic Obstructive Lung Dis, exacerbation mortality

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Click to read Mortality and Exacerbations by Global Initiative for Chronic Obstructive Lung Disease Groups ABCD: 2011 Versus 2017 in the COPDGene® Cohort

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Author Affiliations

1. Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland
2. Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland
3. Department of Physiology, College of Health Sciences, Makerere University, Kampala, Uganda
4. UCL Respiratory, University College London, United Kingdom
5. Department of Medicine and Lung Institute, College of Health Sciences, Makerere University, Kampala, Uganda

Address correspondence to:

Nicole Robertson
Email: Nicolemrobertson01@gmail.com
Phone:(859) 468-9147

Abstract

Introduction: Almost 90% of chronic obstructive pulmonary disease (COPD) deaths occur in low- and middle-income countries (LMICs), where there are large rural populations and access to health care for COPD is poor. The purpose of this study was to compare urban-rural provider experiences regarding systemic facilitators and barriers to COPD management and treatment access.

Methods: We conducted a qualitative study using direct observations and in-depth semi-structured interviews with 16 and 10 health care providers in urban Kampala and rural Nakaseke, Uganda, respectively. We analyzed interviews by performing inductive coding using generated topical codes.

Results: In both urban and rural districts, exposure to evidence-based practices for COPD diagnosis and treatment was limited. The biomedical definition of COPD is not well distinguished in rural communities and was commonly confused with asthma and other respiratory diseases. Urban and rural participants alike described low availability of medications, limited access to diagnostic tools, poor awareness of the disease, and lack of financial means for medical care as common barriers to seeking and receiving care for COPD. While there was greater access to COPD treatment in urban areas, rural populations faced more pronounced barriers in access to diagnostic equipment, following standard treatment guidelines, and training medical personnel in non-communicable disease (NCD) management and treatment.

Conclusion: Our results suggest that health system challenges for the treatment of COPD may disproportionately affect rural areas in Uganda. Implementation of diagnostic and treatment guidelines and training health professionals in COPD, with a special emphasis on rural communities, will assist in addressing these barriers.

Citation

Citation: Robertson NM, Nagourney EM, Pollard SL, et al. Urban-rural disparities in chronic obstructive pulmonary disease management and access in Uganda. J COPD F. 2019; 6(1): 17-28. doi: http://doi.org/10.15326/jcopdf.6.1.2018.0143

Keywords

COPD, chronic obstructive pulmonary disease, Urban-rural health disparities, treatment access, low and middle-income countries, Uganda

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Author Affiliations

1. Research Department, COPD Foundation, Inc., Washington, D.C.
2. Patient & Health Impact, Pfizer, Inc., Collegeville, Pennsylvania
3. College of Public Health, University of Kentucky Lexington, and Consultant, COPD Foundation, Inc.
4. Medical Affairs, Pfizer, Inc., Columbia, Missouri
5. Medical Affairs, Pfizer, Inc., Lexington, Kentucky

Address correspondence to:

Cara B. Pasquale, MPH
Phone: 866-731-2673, ext. 312
Email: cpasquale@copdfoundation.org

Abstract

Community acquired pneumonia (CAP) carries high morbidity, mortality, and economic burden, which is even higher in adults diagnosed with chronic obstructive pulmonary disease (COPD). While several studies have assessed the clinical burden and mortality risk of CAP and COPD, very few studies focus on CAP burden from a COPD patient perspective. Individuals recently diagnosed with CAP and with pre-existing COPD were recruited through the COPD Foundation. The CAP Burden of Illness Questionnaire (CAP-BIQ), a content validated questionnaire assessing CAP symptomatology, duration of symptoms and CAP impact on work, activities and family, was administered at baseline and at 30-days follow-up.

Of the 490 participants recruited, 481 had data sufficient for analysis. The prevalence of respiratory-related symptoms was very high (>90%) at the time of diagnosis with other generalized symptoms such as fatigue, trouble sleeping, headaches and confusion present in more than 60% of participants. Mean duration of symptoms varied from approximately 2 weeks for headaches and fever to more than a month for fatigue, wheezing, dyspnea, and cough. Employed participants missed an average of 21 days of work and those not employed missed 36 days of usual activities. Over 84% required help from family, friends or care givers.

CAP is a serious and burdensome condition for people with COPD, a condition that can impair activities for weeks, frequently requires care from family or friends, and includes lingering symptoms. The patient-reported impact of CAP reported in this study underscores the need for prevention strategies in this population.

Citation

Citation: Pasquale CB, Vietri J, Choate R, et al. Patient-reported consequences of community-acquired pneumonia in patients with chronic obstructive pulmonary disease. J COPD F. 2019; 6(2): 132-144. doi: http://doi.org/10.15326/jcopdf.6.2.2018.0144

Keywords

COPD, patient reported outcomes, symptom burden, community acquired pneumonia, time to resolution

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Click to read Patient-Reported Consequences of Community-Acquired Pneumonia in Patients with Chronic Obstructive Pulmonary Disease

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Author Affiliations

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

Address correspondence to:

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

Abstract

Introduction: Hospitalization for chronic obstructive pulmonary disease (COPD) exacerbation portends the greatest risk of rehospitalization and mortality. Treatments that prevent hospitalizations could significantly lessen COPD morbidity and mortality.

Methods: We performed a prospective, randomized, double-blind, placebo-controlled study of roflumilast 500 ug daily versus placebo in patients hospitalized for acute COPD exacerbation. Primary outcome was time to all-cause mortality or non-elective rehospitalization at 180 days post-randomization. Secondary outcomes were death or hospitalization from a respiratory cause, quality of life, change in health status, forced expiratory volume in 1 second (FEV₁) and roflumilast tolerance.

Results: A total of 64 patients with moderate to severe COPD (FEV₁, 37.6 ± 16.4% predicted; 61% female, 61.6 ± 7.9 years old) were assigned to roflumilast or placebo. No deaths occurred in the follow-up period. There was no difference in the time to first readmission between the roflumilast and placebo groups (46.1 days versus 47.3 days respectively, p=0.93). There were 29 and 30 readmissions in the roflumilast and placebo groups, respectively (p=0.47). The St George’s Respiratory Questionnaire (SGRQ) decreased 10.8 points and 7.8 points in the roflumilast and placebo groups, respectively and were not different. EuroQuality of Life Five Dimension scale (EQ5D) scores improved, but not significantly in either group. Weight loss and nausea were more common with roflumilast but not different from placebo. Change in glycosylated hemoglobin percentage (HgbA1C%) was not different between groups. Sub-analysis for the impact of chronic bronchitis did not affect outcomes.

Conclusion: In this pilot study conducted in patients hospitalized with an exacerbation of COPD, roflumilast did not affect time to all-cause rehospitalization, quality of life, FEV₁ or any other measured parameter.

Citation

Citation: Criner GJ, Jacobs MR, Zhao H, Marchetti N.Effects ofroflumilast on rehospitalization and mortality in patients hospitalized with a COPD exacerbation. J COPD F. 2019; 6(1): 74-85. doi: http://doi.org/10.15326/jcopdf.6.1.2018.0139

Keywords

exacerbations, roflumilast, COPD hospitalization

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Click to read Effects of Roflumilast on Rehospitalization and Mortality in Patients

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Author Affiliations

1. Pulmonary Research Institute of Southeast Michigan, Farmington Hills
2. Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts

Address correspondence to:

Gary T. Ferguson, MD,
Pulmonary Research Institute of Southeast Michigan
29255 West 10 Mile Road, Suite A
Farmington Hills, MI 48336
Phone: 248-478-6561
E-mail: garytferguson@msn.com

Abstract

Purpose: The purpose of this study was to assess the effect of pre-existing cardiovascular (CV) risk factors on the efficacy and safety of nebulized glycopyrrolate (GLY) in patients with chronic obstructive pulmonary disease (COPD).

Methods: A total of 2379 patients from 3 phase III studies (12-week, placebo-controlled Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer [GOLDEN] -3 and -4, and 48-week, active-controlled GOLDEN-5) stratified by high (n=1526) or low (n=853) CV risk were randomized to placebo, GLY 25 mcg or 50 mcg twice daily, or tiotropium (TIO; 18 mcg once daily). Safety, lung function, patient-reported outcomes (PROs), and exacerbations were assessed by CV risk.

Results: Treatment-emergent adverse events (TEAEs) were similar across CV risk subgroups, with serious TEAEs higher in the high CV risk subgroup. In the 12-week studies, discontinuation due to TEAEs with GLY 25 mcg and 50 mcg was similar between CV risk subgroups, and lower than placebo (high risk: 6.2%, 3.6%, 9.0%; low risk: 3.2%, 4.5%, 9.9%, respectively). In the 48-week, open-label study, discontinuation rates were higher with GLY versus TIO (high risk: 10.7%, 3.7%; low risk: 8.7%, 1.2%, respectively). Rates of CV events of special interest were similar across CV risk subgroups. Regardless of CV risk, GLY led to significant improvements in efficacy and PRO assessments at 12 weeks versus placebo, whereas changes were similar between GLY and TIO at 48 weeks, except for PROs in the low risk subgroup. Exacerbation rates were similar across all treatment groups.

Conclusions: Nebulized GLY had an acceptable safety profile and improved lung function and PROs in COPD patients, irrespective of CV risk status.

Citation

Citation: Ferguson GT, Tosiello R, Sanjar S, Goodin T. Efficacy and safety of nebulized glycopyrrolate/eflow® closed system in patients with moderate-to-very-severe chronic obstructive pulmonary disease with pre-existing cardiovascular risk factors. J COPD F. 2019; 6(1): 86-99. doi: http://doi.org/10.15326/jcopdf.6.1.2018.0146

Keywords

COPD, chronic obstructive pulmonary disease, glycopyrrolate, eFlow, nebulized long-acting muscarinic antagonist, LAMA, cardiovascular

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Click to read Efficacy and Safety of Nebulized Glycopyrrolate/eFlow® Closed System in Patients with Moderate-to-Very-Severe Chronic Obstructive Pulmonary Disease with Pre-Existing Cardiovascular Risk Factors

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Author Affiliations

1. RTI Health Solutions, Research Triangle Park, North Carolina
2. Pulmonx Corporation, Redwood City, California
3. Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania
4. Division of Pulmonary and Critical Care Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts

Address correspondence to:

Carol Mansfield
RTI Health Solutions
200 Park Offices Drive
Research Triangle Park, NC, 27709
Email:carolm@rti.org
Phone: 919.541.8053

Abstract

Background: Patients with severe emphysema have limited treatment options. Little is known about patients’ willingness to accept risks for new treatments that offer meaningful benefits.

Methods: We determined treatment preferences of patients with severe emphysema using a web-based discrete-choice experiment survey. Respondents answered 9 questions that offered choices between 2 hypothetical interventional treatments or continuing current medical management. Variations in 5 attributes defined the 2 interventional treatments: improvement in ability to breathe and carry out day-to-day activities, frequency of hospitalized exacerbations, treatment type, risk of pneumothorax within 30 days of procedure, and risk of death within 3 months. Respondents were recruited through the COPD Foundation’s COPD Patient-Powered Research Network and had a self-reported emphysema diagnosis and 2+ score on the modified Medical Research Council Dyspnea Scale. The relative importance of the attributes and the percentage of respondents who would select different treatment options was modeled using random-parameters logit.

Results: Among 294 respondents, 51% always chose an interventional treatment option, while 19% always selected continued medical management. The most important change on average was moving from continued medical management (with no improvement in breathlessness) to an interventional treatment with improvement in breathlessness. The model predicted 71% of respondents would select a treatment option similar to removable endobronchial valve implants, 6% would select lung volume reduction surgery (LVRS), and 23% continued medical management.

Conclusion: Patients with severe emphysema perceive that a procedure with risks and benefits similar to the Zephyr^® endobronchial valve implants is desirable over continued medical management or LVRS.

Citation

Citation: Mansfield C, Sutphin J, Shriner K, Criner GJ, Celli BR. Patient preferences for endobronchial valve treatment of severe emphysema. J COPD F. 2019; 6(1): 51-63. doi: http://doi.org/10.15326/jcopdf.6.1.2018.0147

Keywords

COPD, emphysema, chronic obstructive pulmonary disease, lung volume reduction surgery, endobronchial valves, patient preferences, discrete choice experiment

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Click to read Patient Preferences for Endobronchial Valve Treatment of Severe Emphysema

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Author Affiliations

1. Department of Internal Medicine, University of Michigan, Ann Arbor
2. Department of Clinical Sciences, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania
3. Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania

Address correspondence to:

Rachel N. Criner, MD
Department of Internal Medicine
University of Michigan Health Systems
UH Internal Medicine – Core 3116 TC
1500 E. Medical Center Drive
Ann Arbor, MI 48109
rcriner@med.umich.edu
734-936-4385

Abstract

Abstract

Background: Long-term effects of lung volume reduction surgery (LVRS) on respiratory muscle strength and effects of age, sex, and emphysema pattern on these changes are unknown. Therefore, we aimed to determine the long-term effect of LVRS on respiratory muscle strength changes in severe emphysema.

Methods: The National Emphysema Treatment Trial was a prospective controlled multicentered trial, comparing LVRS to optimal medical treatment on survival and maximal exercise capacity. We examined percentage change in maximum inspiratory pressure (MIP) from baseline to 36 months follow-up to determine impact of LVRS as well as age, sex, emphysema pattern and exercise capacity on changes in MIP compared to medical treatment.

Results: LVRS individuals had significantly greater increases in MIP from baseline compared to medical individuals at all follow-ups (LVRS 19.8 ± 42.3%, medical 3.2 ± 29.3%, p<0.0001, 12 months). The LVRS group had significant decreases in total lung capacity (TLC), residual volume (RV), functional residual capacity (FRC) and RV/TLC compared to the medical arm at all follow-up periods. Males and individuals 65-70 years of age had significantly greater increases in MIP following LVRS compared to the medical arm at all follow-ups; this same relationship was seen at up to 24 months for low exercise capacity, upper lobe predominant emphysema.

Conclusions: LVRS significantly increases inspiratory muscle strength up to 3 years post-operatively, with male sex, age 65-70 years and low exercise capacity, upper lobe predominant emphysema especially associated with increased MIP. Inspiratory muscle strength increases were associated with decreases in non-invasive markers of dynamic hyperinflation, suggesting that LVRS allows inspiratory muscles to return to their optimal length-tension relationship.

Citation

Citation: Criner RN, Yu D, Jacobs MR, Criner GJ. Effect of lung volume reduction surgery on respiratory muscle strength in advanced emphysema. J COPD F. 2019; 6(1): 40-50. doi: http://doi.org/10.15326/jcopdf.6.1.2018.0188

Keywords

emphysema, exercise capacity, lung volume reduction surgery, dynamic hyperinflation, respiratory muscle strength, mean inspiratory pressure, sex, age

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Click to read Effect of Lung Volume Reduction Surgery on Respiratory Muscle Strength in Advanced Emphysema

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Author Affiliations

1. Department of Preventive Medicine and Environmental Health, University of Kentucky College of Public Health, Lexington
2. Division of Medical, Behavioral, and Community Health, National Jewish Health; Department of Community and Behavioral Health, University of Colorado Denver School of Public Health, Denver
3. Division of Pulmonary Sciences and Critical Care Medicine, National Jewish Health, University of Colorado Denver School of Medicine, Denver

Address correspondence to:

Radmila Choate, MPH
Department of Preventive Medicine and Environmental Health
University of Kentucky College of Public Health
111 Washington Avenue
Lexington, KY 40536
Phone: 859-218-2237
E-mail: radmila.choate@uky.edu

Abstract

Background: The aim of this study was to examine differences in demographic, health, and behavioral characteristics in individuals with ZZ and SZ genotypes of alpha-1 antitrypsin deficiency (AATD) within AlphaNet’s Disease Management and Prevention Program (ADMAPP).

Methods: Self-reported data from 3535 patients with AATD, including 3031 (85.7%) patients with ZZ, ZNull, and NullNull genotypes (referred to here as ZZ), and 504 (14.3%) with the SZ genotype were analyzed using t-tests, ANOVAs, and Chi-squared tests.

Results: The average age of the cohort was 56.3±10.6 years. The majority of respondents were male (51.2%), white (98.2%) and married (65.2%). SZs reported having more frequent exacerbations (p<0.001) and hospitalizations (p=0.012) than ZZs. A higher proportion of SZs than ZZs had been diagnosed with high blood pressure, diabetes, congestive heart failure, and other comorbid conditions. SZs were more likely than ZZs to report “poor” health (p=0.005). Over a third (38.4%) of SZs do not exercise compared to 27.1% of ZZs (p<0.001). A greater proportion of SZs compared to ZZs view themselves as being overweight (p<0.001) or “out of shape” (p=0.001). A higher proportion of SZs than ZZs reported any history of smoking and current smoking (p<0.001).

Conclusions: In patients with AATD and lung disease participating in a disease management program, a higher proportion of SZs than ZZs report exacerbations, comorbidities, and overall poor health, as well as unhealthy behaviors such as lack of exercise and current smoking. Future work should consider the extent to which genotype-specific health promotion interventions would be useful.

Citation

Citation: Choate R, Mannino DM, Holm KE, Sandhaus RA. Comparing patients with ZZ versus SZ alpha-1 antitrypsin deficiency: findings from AlphaNet’s disease management program. J COPD F. 2019; 6(1): 29-39. doi: http://doi.org/10.15326/jcopdf.6.1.2018.0134

Keywords

alpha-1 antitrypsin deficiency, genotype, AlphaNet Disease Management and Prevention Program, ADMAPP, ZZ, SZ

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Click to read Comparing Patients with ZZ Versus SZ Alpha-1 Antitrypsin Deficiency: Findings from AlphaNet’s Disease Management Program

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Author Affiliations

1. Division of Pulmonary, Critical Care and Sleep Medicine, University of Florida, Gainesville

Address correspondence to:

Mark L. Brantly, MD
Division of Pulmonary, Critical Care, and Sleep Medicine
College of Medicine
University of Florida
JHMHC PO Box 100225
Gainesville, FL 32610
Email: mbrantly@ufl.edu
Phone: (352)273-8737

Abstract

Alpha-1 antitrypsin deficiency (AATD) is a largely monogenetic disorder associated with a high risk for the development of chronic obstructive pulmonary disease (COPD) and cirrhosis. Intravenous alpha-1 antitrypsin (AAT) therapy has been available for the treatment of individuals with AATD and COPD since the late 1980s. Initial Food and Drug Administration (FDA) approval was granted based on biochemical efficacy. Following its approval, the FDA, scientific community and third-party payers encouraged manufacturers of AAT therapy to determine its clinical efficacy. This task has proved challenging because AATD is a rare, orphan disorder comprised of individuals who are geographically dispersed and infrequently identified. In addition, robust clinical trial outcomes have been lacking until recently. This review provides an update on the evidence for the clinical efficacy of intravenous AAT therapy for patients with AATD-related emphysema.

Citation

Citation: Brantly ML, Lascano JE, Shahmohammadi A. Intravenous alpha-1 antitrypsin therapy for alpha-1 antitrypsin deficiency: the current state of the evidence.

Keywords

COPD, emphysema, alpha-1 antitrypsin deficiency, AAT therapy, clinical efficacy, disease modification

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Click to read Intravenous Alpha-1 Antitrypsin Therapy for Alpha-1 Antitrypsin Deficiency: The Current State of the Evidence

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Author Affiliations

1. Pharmaceutical Health Services Research Department, School of Pharmacy, University of Maryland, Baltimore
2. OptumLabs, Cambridge, Massachusetts
3. Division of Pulmonary, Critical Care and Sleep Medicine, National Jewish Health, Denver, Colorado
4. School of Medicine, University of Maryland, Baltimore
5. Division of Medical, Behavioral, and Community Health, National Jewish Health, Denver, Colorado

Address correspondence to:

C. Daniel Mullins, PhD
Pharmaceutical Health Services Research Department
University of Maryland School of Pharmacy
220 N Arch St, 12^th Floor
Baltimore, MD 21201-1531 Email: Daniel.Mullins@rx.umaryland.edu

Abstract

Background: This study is the first to utilize a large claims database to estimate medical costs of patients with alpha-1 antitrypsin deficiency (AATD) in the United States.

Methods: Adult AATD patients were identified from the OptumLabs™ Data Warehouse. Insurer and patient out-of-pocket costs were categorized into the following cost buckets, stratified by augmentation therapy use: physician visits (PV), emergency department visits (ED), inpatient stays (IP), augmentation therapy (AUG), other prescription drug costs (RX), and other costs (OTH). Costs were weighted and adjusted to 2017 U.S. dollars using the medical care component of the consumer price index.

Results: The study cohort consisted of9117 AATD patients followed for 53,872 person years observed between 1993 and 2015. The annual costs among AATD patients totaled $127,537 among augmentation therapy users and $15,874 among non-users. The major drivers of annual costs to the insurer among the 7975 patients not on augmentation therapy were: PV: $5352 (37.7%) and IP: $4506 (31.8%). Among the 1142 augmentation users, major annual cost drivers to the insurer were PV: $15,064 (12.3%) and AUG: $82,002 (66.7%). Annual patient out-of-pocket costs were $4601 (AUG: $2084 [45.3%]; RX: $940 [20.4%]) and $1689 (PV: $727 [43.0%]; RX: $589 [34.9%]) among augmentation therapy users and non-users, respectively. Averaged across the entire cohort, the average annual costs per AATD patient were $22,975, paid by insurers ($21,100) and patients ($1875).

Conclusions: Annual medical costs among patients with AATD are $127,537 and $15,874 among augmentation therapy users and non-users, respectively, with 75.3% of the cost difference attributable to AUG.

Citation

Citation: Sieluk J, Levy J, Sandhaus RA, Silverman H, Holm KE, Mullins CD. Costs of medical care among augmentation therapy users and non-users with alpha-1 antitrypsin deficiency in the United States. J COPD F. 2019; 6(1): 6-16. doi: http://doi.org/10.15326/jcopdf.6.1.2017.0187

Keywords

chronic obstructive pulmonary disease, alpha-1 antitrypsin deficiency, pharmacoeconomics, medical costs, augmentation therapy

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Click to read Costs of Medical Care Among Augmentation Therapy Users and Non-Users with Alpha-1 Antitrypsin Deficiency in the United States

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Author Affiliations

1. COPD Foundation, Washington, DC

Address correspondence to:

Elisha Malanga
COPD Foundation
Email: emalanga@copdfoundation.org
Phone: 866-731-2673 x309

Abstract

This article does not contain an abstract.

Citation

Citation: Malanga E, Malanga V, Latham S. Websites, online communities and digital channels as a medium to effectively educate, engage and empower patients. J COPD F. 2018; 5(4): 334-337. doi: http://doi.org/10.15326/jcopdf.5.4.2018.0158

Keywords

online communities, websites, digital channels, patient education, patient engagement

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Click to read Websites, Online Communities and Digital Channels as a Medium to Effectively Educate, Engage and Empower Patients

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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 - Asthma /chronic obstructive pulmonary disease overlap: fact or fiction? J COPD F. 2018; 5(4): 341-350. doi: http://doi.org/10.15326/jcopdf.5.4.2018.0162

Keywords

COPD, chronic obstructive pulmonary disease, asthma

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Click to read Journal Club - Asthma/Chronic Obstructive Pulmonary Disease Overlap: Fact or Fiction?

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Author Affiliations

1. St Francis Hospital and University Medical Research, LLC

Address correspondence to:

Nicholas Gross, MD, PhD
Grossnicholas1@gmail.com

Abstract

This article does not contain an abstract.

Citation

Citation: Gross N. COPD pipeline XXXIX. J COPD F. 2018; 5(4): 338-340. doi: http://doi.org/10.15326/jcopdf.5.4.2018.0155

Keywords

long-acting muscarinic antagonist, long-acting beta2-agonist, umeclidinium, vilanterol, phosphodiesterase, non-typeable Haemophilus influenza, Moraxella catarrhalis

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Click to read The COPD Pipeline XXXIX

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Author Affiliations

1. MedStar Georgetown University Hospital; Georgetown University Medical Center, Washington, DC
2. Mayo Clinic, Rochester, Minnesota

Address correspondence to:

Anne E. O'Donnell, MD
Phone: 202-444-8830
Email: ODONNELA@gunet.georgetown.edu

Abstract

This article does not contain an abstract.

Citation

Citation: O’Donnell AE, Aksamit TR. Abstracts: 3rd World Bronchiectasis Conference. J COPD F. 2018; 5(4): 302-323. doi: http://doi.org/10.15326/jcopdf.5.4.2018.0132

Keywords

bronchiectasis, nontuberculous mycobacterial lung infections, NTM, 3rd World Bronchiectasis Conference

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Click to read 3rd World Bronchiectasis Conference

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Author Affiliations

1. COPD Foundation, Washington, DC
2. University of Kentucky, College of Public Health, Lexington
3. GlaxoSmithKline, Philadelphia, Pennsylvania

^* contributed equally to this report

Address correspondence to:

Jamie Sullivan, MPH
COPD Foundation
1140 3^rd St. NE
2^nd Floor
Washington, DC 20002
Email: jsullivan@copdfoundation.org
Phone: 866-731-2678 ext. 455

Abstract

Background: Chronic obstructive pulmonary disease (COPD) remains a leading cause of disability and death in the United States. The “COPD in the United States” project gathered data about the impact of COPD to highlight variability across states and provide a single point of access to data for state decision makers, the public health community and advocates. This report provides a summary of COPD-related morbidity and mortality in the United States and individual states during 2014-2015 (some metrics contain data from other years).

Methods: We used data from multiple sources ( the Behavioral Risk Factor Surveillance System [BRFSS], the Centers for Disease Control and Prevention (CDC) Wide-ranging ONline Data for Epidemiologic Research online database, the CDC’s chronic disease indicators data, Centers from Medicare and Medicaid Services Chronic Conditions Data Warehouse, Medical Expenditures Panel Survey and the American Association of Cardiovascular and Pulmonary Rehabilitation Pulmonary Rehabilitation Directory) to estimate 10 national and state-specific COPD metrics (prevalence, hospitalizations and emergency department visits, 30-day hospital readmissions, mortality, vaccinations, smoking prevalence, per capita medical cost, and the number of COPD patients per a pulmonary rehabilitation program) and to calculate average score across the 10 metrics. Additionally, we used BRFSS data to calculate the prevalence of common comorbid diseases among people who also report having a diagnosis of COPD.

Results: During 2014-2015, 5.9% of adults (more than 15.9 million) reported having been told by their health care professional that they had COPD. The age-adjusted prevalence ranged from 3.7% for Puerto Rico and Hawaii, to 12% for West Virginia. The average score, 1 being best and 5 being worst, of the overall COPD burden based on the 10 key metrics ranged from 1.5 for Puerto Rico and Utah to 4.6 for West Virginia.

Conclusion: The level of COPD morbidity and mortality is severe throughout the United States. There is considerable variability in COPD metrics by state. These differences may be useful in identifying and addressing policy gaps in the public health approach to COPD and in implementing the COPD National Action Plan.

Citation

Citation: Sullivan J, Pravosud V, Mannino DM, Siegel K, Choate R, Sullivan T. National and state estimates of COPD morbidity and mortality — United States, 2014-2015. J COPD F. 2018; 5(4): 324-333. doi: http://doi.org/10.15326/jcopdf.5.4.2018.0157

Keywords

COPD, chronic obstructive pulmonary disease, mortality, comorbidities, Behavioral Risk Factor Surveillance System, prevalence, state data, morbidity

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Click to read National and State Estimates of COPD Morbidity and Mortality — United States, 2014-2015

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Author Affiliations

1. Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Department of Medicine, University of Miami, Miller School of Medicine, Miami, Florida

Address correspondence to:

Adam Wanner, MD
Phone: (305) 243-3045
Email: awanner@alpha1.org

Abstract

This article does not contain an abstract.

Citation

Citation: Wanner A. Editorial. Why publish scientific meeting proceedings? J COPD F. 2018; 5(4): 231-232. doi: http://doi.org/10.15326/jcopdf.5.4.2018.0159

Keywords

alpha-1 antitrypsin deficiency, scientific proceedings, new therapies

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Author Affiliations

Kenneth R. Chapman
Asthma & Airway Centre
University Health Network
University of Toronto
Room 7-451 East Wing, 399 Bathurst Street
Toronto, Ontario M5T 2S8
Phone: 416-603-5499
Email: ken.chapman.airways@gmail.com

Address correspondence to:

1. University of Toronto and Asthma & Airway Centre, University Health Network, Toronto, Ontario

Abstract

This article does not contain an abstract.

Citation

Citation: Chapman KR. Editorial. Increasing awareness of COPD: two steps forward, one step back. J COPD F. 2018; 5(4): 228-230. doi: http://doi.org/10.15326/jcopdf.5.4.2018.0154

Keywords

COPD, chronic obstructive pulmonary disease, awareness, underdiagnosis, gender bias, racial bias

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Click to read Increasing Awareness of COPD: Two Steps Forward, One Step Back

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Author Affiliations

1. Respiratory Division, Department of Medicine, Faculty of Medicine and Health Sciences, University of Sherbrooke, Quebec Canada
2. Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Quebec, Canada

Address correspondence to:

André M. Cantin, MD
Pulmonary Research Unit
Faculty of Medicine, University of Sherbrooke
3001, 12^ième Avenue Nord, Fleurimont, QC
Canada J1H 5N4
Phone number: 819-346-1110 ext. 14893
Email: Andre.Cantin@USherbrooke.ca

Abstract

Antioxidants represent an attractive therapeutic avenue for individuals with chronic obstructive pulmonary disease (COPD). Cigarette smoke, the major cause of COPD, contains very high concentrations of gaseous and soluble oxidants that can directly induce cell injury and death. Furthermore, particulate matter in cigarette smoke activates lung macrophages that subsequently attract neutrophils. Both neutrophils and macrophages from the lungs of cigarette smokers continuously release large amounts of superoxide and hydrogen peroxide through the nicotinamide adenine dinucleotide phosphate (NADPH) oxidase complex. Once individuals with COPD stop smoking, the neutrophilic inflammation in the airways and lung parenchyma persists, as do the markers of oxidative stress. Several animal models of cigarette smoke-induced injury have provided evidence that various antioxidants may prevent inflammation and morphological changes associated with COPD however, evidence of benefit in patients is less abundant. Although oxidants can inactivate alpha-1 antitrypsin and other protective proteins, damage lung tissue, and increase mucus production, they also are essential for killing pathogens and resolving inflammation. This review will examine the pre-clinical and clinical evidence of a role for antioxidants in the therapy of patients with COPD.

Citation

Citation: Vézina FA, Cantin AM. Antioxidants and chronic obstructive pulmonary disease. J COPD F. 2018; 5(4): 277-288. doi: http://doi.org/10.15326/jcopdf.5.4.2018.0133

Keywords

emphysema, inflammation, alpha-1antitrypsin, N-acetylcysteine, cigarette smoke

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Click to read Antioxidants and Chronic Obstructive Pulmonary Disease

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Author Affiliations

1. Department of Pharmaceutics, College of Pharmacy, University of Florida, Gainesville

Address correspondence to:

Sihong Song, PhD
Department of Pharmaceutics
College of Pharmacy University of Florida
Gainesville, FL 32610
Email: shsong@ufl.edu
Phone: 352-273-7867

Abstract

Autoimmune diseases are conditions caused by an over reactive immune system that attacks self-tissues and organs. Although the pathogenesis of autoimmune disease is complex and multi-factorial, inflammation is commonly involved. Therefore, anti-inflammatory therapies hold potential for the treatment of autoimmune diseases. However, long-term control of inflammation is challenging and most of the currently used drugs have side effects. Alpha-1 antitrypsin (AAT) is an anti-inflammatory protein with a well-known safety profile. The therapeutic potential of AAT has been tested in several autoimmune disease models. The first study using a recombinant adeno-associated viral (rAAV) vector showed that AAT gene transfer prevented the development of type 1 diabetes (T1D) in the non-obese diabetic (NOD) mouse model. Subsequent studies showed that treatment with AAT protein prevented and reversed type 1 diabetes. The beneficial effects of AAT treatment have also been observed in other autoimmune disease models such as rheumatoid arthritis and systemic lupus erythematosus. This paper reviews the therapeutic application of AAT and discusses possible mechanisms of action in various autoimmune diseases.

Citation

Citation: Song S. Alpha-1 antitrypsin therapy for autoimmune disorders. J COPD F. 2018; 5(4): 289-301. doi: http://doi.org/10.15326/jcopdf.5.4.2018.0131

Keywords

chronic obstructive pulmonary disease, alpha-1 antitrypsin deficiency, alpha-1 antitrypsin, autoimmunity, type 1 diabetes, rheumatoid arthritis, systemic lupus erythematosus

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Click to read Alpha-1 Antitrypsin Therapy for Autoimmune Disorders

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Author Affiliations

1. Center for Regenerative Medicine of Boston University and Boston Medical Center, Boston, Massachusetts

Address correspondence to:

Andrew A. Wilson, MD
Center for Regenerative Medicine
Boston University and Boston Medical Center
670 Albany St., 2nd Floor
Boston, MA 02118
Tel: 617-414-3282
Fax: 617-536-8093
Email: awilson@bu.edu

Abstract

PIZZ alpha-1 antitrypsin deficiency (AATD) is an autosomal recessive disease affecting approximately 100,000 individuals in the United States and one of the most common hereditary causes of liver disease.¹ The most common form of the disease results from a single base pair mutation (Glu342Lys), known as the “Z” mutation, that encodes a mutant protein (Z alpha-1 antritypsin [AAT]) that is prone to misfolding and is retained in the endoplasmic reticulum (ER) rather than appropriately secreted. Some of the retained mutant protein attains an unusual aggregated or polymerized conformation. Retained polymeric ZAAT aggregates are hepatotoxic and lead to downstream liver disease in a subset of PiZZ neonates and adults through a gain-of-function mechanism. PiZZ individuals are likewise highly predisposed to developing chronic obstructive pulmonary disease (COPD)/emphysema as a result of low circulating levels of AAT protein and associated protease-antiprotease imbalance. Much of our understanding of the molecular pathogenesis of AATD is based on studies employing either transgenic mice that express the mutant human Z allele or immortalized cell lines transduced to overexpress ZAAT. While they have been quite informative, these models fail to capture the patient-to-patient variability in disease phenotype that clinicians observe in their AATD patients, raising the question of whether alternative models might provide new insight. Induced pluripotent stem cells (iPSCs), first described in 2006, have the capacity to differentiate into a broad array of cell types from all 3 germ layers, including hepatocytes. Disease-specific iPSCs have been derived from patients with a variety of monogenic disorders and have been found to faithfully recapitulate features of such diseases as spinal muscular atrophy, familial dysautonomia, Rett syndrome, polycythemia vera, type 1A glycogen storage disease, familial hypercholesterolemia, long QT syndrome, and others. This discussion reviews the potential applications of iPSCs for understanding AATD-associated liver disease as well as for development of potential therapeutic strategies.

Citation

Citation: Kaserman JE, Wilson AA. Patient-derived induced pluripotent stem cells for alpha-1 antitrypsin deficiency disease modeling and therapeutic discovery. J COPD F. 2018; 5(4): 258-266. doi: http://doi.org/10.15326/jcopdf.5.4.2017.0179

Keywords

alpha-1 antitrypsin deficiency, induced pluripotent stem cells, protein misfolding

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Click to read Patient-Derived Induced Pluripotent Stem Cells for Alpha-1 Antitrypsin Deficiency Disease Modeling and Therapeutic Discovery

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Author Affiliations

1. Department of Clinical Biochemistry and Pharmacology, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel

Address correspondence to:

Eli C. Lewis, PhD
Department of Clinical Biochemistry & Pharmacology
Faculty of Health Sciences
Ben-Gurion University of the Negev
POB 151, Be’er-Sheva 8410501, Israel
Phone: ++972-8-6244-574
e-mail: lewis@bgu.ac.il

Abstract

Alpha-1 antitrypsin deficiency (AATD) is a genetic disorder which most commonly manifests as pulmonary emphysema. Accordingly, alpha-1 antitrypsin (AAT) augmentation therapy aims to reduce the progression of emphysema, as achieved by life-long weekly slow-drip infusions of plasma-derived affinity-purified human AAT. However, not all AATD patients will receive this therapy, due to either lack of medical coverage or low patient compliance. To circumvent these limitations, attempts are being made to develop lung-directed therapies, including inhaled AAT and locally-delivered AAT gene therapy. Lung transplantation is also an ultimate therapy option. Although less common, AATD patients also present with disease manifestations that extend beyond the lung, including vasculitis, diabetes and panniculitis, and appear to experience longer and more frequent hospitalization times and more frequent pneumonia bouts. In the past decade, new mechanism-based clinical indications for AAT therapy have surfaced, depicting a safe, anti-inflammatory, immunomodulatory and tissue-protective agent. Introduced to non-AATD individuals, AAT appears to provide relief from steroid-refractory graft-versus-host disease, from bacterial infections in cystic fibrosis and from autoimmune diabetes; preclinical studies show benefit also in multiple sclerosis, ulcerative colitis, rheumatoid arthritis, acute myocardial infarction and stroke, as well as ischemia-reperfusion injury and aberrant wound healing processes. While the current augmentation therapy is targeted towards treatment of emphysema, it is suggested that AATD patients may benefit from AAT augmentation therapy geared towards extrapulmonary pathologies as well. Thus, development of mechanism-based, context-specific AAT augmentation therapy protocols is encouraged. In the current review, we will discuss extrapulmonary manifestations of AATD and the potential of AAT augmentation therapy for these conditions.

Citation

Citation: Baranovski BM, Schuster R, Nisim O, Brami I, Lewis EC. Alpha-1 antitrypsin substitution for extrapulmonary conditions in alpha-1 antitrypsin deficient patients. J COPD F. 2018; 5(4): 267-276. doi: http://doi.org/10.15326/jcopdf.5.4.2017.0161

Keywords

inflammation, diabetes, autoimmunity, bone-marrow transplantation, cell survival, immune system, leukemia, organ transplantation, ulcerative colitis, wound healing

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Click to read Alpha-1 Antitrypsin Substitution for Extrapulmonary Conditions in Alpha-1 Antitrypsin Deficient Patients

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Author Affiliations

1. Department of Genetic Medicine, Weill Cornell Medical College, New York, New York

*  KMS and DS contributed equally to this review

Address correspondence to:

Katie M. Stiles, PhD or
Dolan Sondhi, PhD
Department of Genetic Medicine
Weill Cornell Medical College
1300 York Avenue, Box 164
New York, New York 10065
Phone: (646) 962-4363
Fax: (646) 962-0220
E-mail: geneticmedicine@med.cornell.edu

Abstract

Alpha-1 antitrypsin deficiency (AATD) manifests primarily as early-onset emphysema caused by the destruction of the lung by neutrophil elastase due to low amounts of the serine protease inhibitor alpha-1 antitrypsin (AAT). The current therapy involves weekly intravenous infusions of AAT-derived from pooled human plasma that is efficacious, yet costly. Gene therapy applications designed to provide constant levels of the AAT protein are currently under development. The challenge is for gene therapy to provide sufficient amounts of AAT to normalize the inhibitor level and anti-neutrophil elastase capacity in the lung. One strategy involves administration of an adeno-associated virus (AAV) gene therapy vector to the pleural space providing both local and systemic production of AAT to reach consistent therapeutic levels. This review focuses on the strategy, advantages, challenges, and updates for intrapleural administration of gene therapy vectors for the treatment of AATD.

Citation

Citation: Stiles KM, Sondhi D, Kaminsky SM, De BP, Rosenberg JB, Crystal RG. Intrapleural gene therapy for alpha-1 antitrypsin deficiency-related lung disease. J COPD F. 2018; 5(4): 244-257. doi: http://doi.org/10.15326/jcopdf.5.4.2017.0160

Keywords

alpha-1 antitrypsin deficiency, gene therapy

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Click to read Intrapleural Gene Therapy for Alpha-1 Antitrypsin Deficiency-Related Lung Disease

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Author Affiliations

1. UCL Respiratory, Division of Medicine, University College London, United Kingdom

Address correspondence to:

David Lomas, MD, PhD
UCL Respiratory, Division of Medicine
Rayne Building
University College London
WC1E 6BN
London, UK
Email: d.lomas@ucl.ac.uk

Abstract

Alpha-1antitrypsin deficiency (AATD) results from the intracellular polymerization and retention of mutant alpha-1antitrypsin (AAT) within the endoplasmic reticulum of hepatocytes. This causes cirrhosis whilst the deficiency of circulating AAT predisposes to early onset emphysema. This is an exciting time for researchers in the field with the development of novel therapies based on understanding the pathobiology of disease. I review here augmentation therapy to prevent the progression of lung disease and a range of approaches to treat the liver disease associated with the accumulation of mutant AAT: modifying proteostasis networks that are activated by Z AAT polymers, stimulating autophagy, small interfering RNA and small molecules to block intracellular polymerization, and stem cell technology to correct the genetic defect that underlies AATD.

Citation

Citation: Lomas DA. New therapeutic targets for alpha-1 antitrypsin deficiency. J COPD F. 2018; 5(4): 233-243. doi: http://doi.org/10.15326/jcopdf.5.4.2017.0165

Keywords

emphysema, alpha-1 antitrypsin deficiency, cirrhosis, conformational disease, small molecules, siRNA, proteostasis, autophagy

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Click to read New Therapeutic Targets for Alpha-1 Antitrypsin Deficiency

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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. Impact of the IMPACT Trial. J COPD F. 2018; 5(3): 221-227. doi: http://doi.org/10.15326/jcopdf.5.3.2018.0150

Keywords

There are no keywords for this article.

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Click to read Impact of the IMPACT Trial

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Author Affiliations

1. Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine, Temple University Health System, Philadelphia, Pennsylvania
2. Department of Epidemiology, Colorado School of Public Health, Anschutz Medical Campus, University of Colorado, Aurora
3. Division of Pulmonary, Allergy and Critical Care Medicine, University of Alabama, Birmingham
4. Division of Pulmonary and Critical Care Medicine, Morehouse School of Medicine, Atlanta, Georgia

Address correspondence to:

A. James Mamary, MD
Temple Lung Center 745
Parkinson Pavilion 3401
North Broad Street Philadelphia Pa, 19140
Phone: 215-707-3332
Email: albert.mamary@tuhs.temple.edu

Abstract

The COPD Genetic Epidemiology (COPDGene®) study provides a rich cross-sectional dataset of patients with substantial tobacco smoke exposure, varied by race, gender, chronic obstructive pulmonary disease (COPD) diagnosis, and disease. We aimed to determine the influence of race, gender and Global initiative for chronic Obstructive Lung Disease (GOLD) stage on prevalence of prior COPD diagnosis at COPDGene® enrollment. Data from the complete phase 1 cohort of 10,192 participants were analyzed. Participants were non-Hispanic white and African-American, ≥45 years of age with a minimum of 10 pack years of cigarette smoking. Characterization upon enrollment included spirometry, demographics and history of COPD diagnosis determined by questionnaire. We evaluated the effects of race and gender on the likelihood of prior diagnosis of COPD and the interaction of race and GOLD stage, and gender and GOLD stage, as determined at study enrollment, on likelihood of prior diagnosis of COPD. We evaluated the 3-way interaction of race, gender and GOLD stage on prior diagnosis. African-Americans had higher odds of not having a prior COPD diagnosis at all GOLD stages of airflow obstruction versus non-Hispanic whites (p<0.0001). Women had higher odds of having a prior COPD diagnosis at all GOLD stages versus men (p<0.0001). Three-way interaction of race, gender and GOLD stage was not significant. African-Americans were less likely to have prior COPD regardless of the severity of airflow obstruction determined at study enrollment. Women were more likely to have a prior COPD diagnosis regardless of the severity of measured airflow obstruction. Race and gender are associated with significant disparities in COPD diagnosis.

Citation

Citation: Mamary AJ, Stewart JI, Kinney GL, et al for the COPDGene investigators. Race and gender disparities are evident in COPD underdiagnoses across all severities of measured airflow obstruction. J COPD F. 2018; 5(3): 177-184. doi: http://doi.org/10.15326/jcopdf.5.3.2017.0145

Keywords

spirometry, diagnosis, asthma, tobacco, epidemiology, smokers

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Click to read Race and Gender Disparities are Evident in COPD Underdiagnoses Across all Severities of Measured Airflow Obstruction

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Author Affiliations

1. Division of Pulmonary and Critical Care Medicine, Department of Medicine, Intermountain Medical Center, Murray, Utah
2. Division of Respiratory, Critical Care, and Sleep Medicine, Department of Medicine, University of Utah, Salt Lake City
3. Office of Research, Intermountain Healthcare, Salt Lake City, Utah
4. Homer Warner Center for Informatics Research, Murray, Utah
5. Section of General Internal Medicine, Department of Medicine, University of Chicago Medicine, Chicago, Illinois
6. Kaiser Permanente Center for Health Research – Northwest, Portland, Oregon
7. Division of Pulmonary and Critical Care Medicine, Oregon Health and Science University, Portland
8. Division of Pulmonary and Critical Care Medicine, San Francisco Veterans Affairs Medical Center, San Francisco, California
9. Division of Pulmonary, Critical Care Allergy, Immunology and Sleep Medicine, Department of Medicine, University of California, San Francisco

Address correspondence to:

Denitza P. Blagev, MD
Intermountain Medical Center
Heart Lung Building, 6^th Floor
5121 South Cottonwood Street
Murray, UT 84157
Email: denitza.blagev@imail.org
denitza.blagev@gmail.com
Phone: (801) 507 4695

Abstract

Rationale: Although chronic obstructive pulmonary disease (COPD) exacerbation frequency is stable in research cohorts, whether severe COPD exacerbation frequency can be used to identify patients at high risk for future severe COPD exacerbations and/or mortality is unknown.

Methods: Severe COPD exacerbation frequency stability was determined in 3 distinct clinical cohorts. A total of 17,450 patients with COPD in Intermountain Healthcare were categorized based on the number of severe COPD exacerbations per year. We determined whether exacerbation frequency was stable and whether it predicted mortality. These findings were validated in 83,134 patients from the U.S. Veterans Affairs (VA) nationwide health care system and 3326 patients from the University of Chicago Medicine health system.

Results: In the Intermountain Healthcare cohort, the majority (84%, 14,706 patients) had no exacerbations in 2009 and were likely to remain non-exacerbators with a significantly lower 6-year mortality compared with frequent exacerbators (2 or more exacerbations per year) (25% versus 57%, p<0.001). Similar findings were noted in the VA health system and the University of Chicago Medicine health system. Non-exacerbators were likely to remain non-exacerbators with the lowest overall mortality. In all cohorts, frequent exacerbator was not a stable phenotype until patients had at least 2 consecutive years of frequent exacerbations. COPD exacerbation frequency predicted any cause mortality.

Conclusions: In clinical datasets across different organizations, severe COPD exacerbation frequency was stable after at least 2 consecutive years of frequent exacerbations. Thus, severe COPD exacerbation frequency identifies patients across a health care system at high risk for future COPD-related health care utilization and overall mortality.

Citation

Citation: Blagev DP, Collingridge DS, Rea S, et al. Stability of frequency of severe chronic obstructive pulmonary disease exacerbations and health care utilization in clinical populations. J COPD F. 2018; 5(3): 208-220. doi: http://doi.org/10.15326/jcopdf.5.3.2017.0183

Keywords

chronic obstructive pulmonary disease, COPD exacerbation, health care utilization, stability

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Click to read Stability of Frequency of Severe Chronic Obstructive Pulmonary Disease Exacerbations and Health Care Utilization in Clinical Populations

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Author Affiliations

1. Pulmonary Research Institute of Southeast Michigan, Farmington Hills
2. Clinical Research Institute of Southern Oregon, PC, Medford
3. University of North Carolina School of Medicine, Chapel Hill
4. Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts
5. Abilytic, Inc., Shrewsbury, Massachusetts

Address correspondence to:

Gary T. Ferguson, MD
Pulmonary Research Institute of Southeast Michigan
29255 West 10 Mile Road, Suite A
Farmington Hills, MI 48336
Tel: (248) 478-6561
Fax: (248) 478-6908
Email: garytferguson@msn.com

Abstract

Background: Symptoms of chronic obstructive pulmonary disease (COPD) may diminish patients’ health-related quality of life (HRQoL). We report effects of Longhala™ Magnair™ (glycopyrrolate) Inhalation Solution, a drug/device combination of the long-acting antimuscarinic glycopyrrolate administered using the eFlow® closed system (eFlow CS) nebulizer, on HRQoL from the Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer (GOLDEN) clinical studies.

Methods: Data consisted of a pooled analysis of 2 phase 3, 12-week efficacy studies (GOLDEN-3 and -4) of glycopyrrolate/eFlow CS (25 or 50 mcg twice daily [BID]) versus placebo, and a 48-week, open-label safety study (GOLDEN-5) of glycopyrrolate/eFlow CS 50 mcg BID versus tiotropium 18 mcg once daily in patients with moderate to very severe COPD. Change from baseline in HRQoL was measured via the St George’s Respiratory Questionnaire (SGRQ). Results are provided as mean changes in SGRQ Total score and as response analysis (≥4-point improvement [responder], no change, and ≥4-point worsening in Total score) using analysis of covariance or logistic regression, as applicable.

Results: A total of 1293 patients were evaluated from GOLDEN-3 and -4 and 1086 from GOLDEN-5. Glycopyrrolate/eFlow CS significantly improved SGRQ Total and component scores. The percentage of SGRQ responders in pooled GOLDEN-3/4 was 46.8% for glycopyrrolate/eFlow CS 25 mcg, 41.7% for glycopyrrolate/eFlow CS 50 mcg, and 34.5% for placebo. SGRQ Total and component score improvements were similar between glycopyrrolate/eFlow CS and tiotropium in GOLDEN-5.

Conclusions: The drug/device combination of glycopyrrolate/eFlow CS significantly improved HRQoL, as measured by the SGRQ, offering a potential maintenance treatment option in patients with moderate to very severe COPD.

ClinicalTrials.gov: NCT02347761, NCT02347774, NCT02276222

Citation

Citation: Ferguson GT, Kerwin EM, Donohue JF, et al. Health-related quality of life improvements in moderate to very severe chronic obstructive pulmonary disease patients on nebulized glycopyrrolate: evidence from the GOLDEN studies. J COPD F. 2018; 5(3): 193-207. doi: http://doi.org/10.15326/jcopdf.5.3.2017.0178

Keywords

COPD, chronic obstructive pulmonary disease, health status, long-acting muscarinic antagonist, health-related quality of life, nebulizer, HRQoL

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Click to read Health-Related Quality of Life Improvements in Moderate to Very Severe Chronic Obstructive Pulmonary Disease Patients on Nebulized Glycopyrrolate: Evidence from the GOLDEN Studies

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Author Affiliations

1. Department of Internal Medicine, Danbury Hospital, Western Connecticut Health Network, Danbury
2. Department of Research & Innovation, Danbury Hospital, Western Connecticut Health Network, Danbury
3. Section of Pulmonary Medicine, Department of Internal Medicine, Danbury Hospital, Western Connecticut Health Network, Danbury

Address correspondence to:

John Chronakos, MD
33 Germantown Road
Danbury, CT 06810
E-mail: john.chronakos@gmail.com
Phone: (203)739-6805

Abstract

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is one of the leading causes of hospitalization in the United States. Prior investigations suggest clinical and physiological parameters are important determinants for AECOPD readmissions. Strategies aimed at addressing these factors have not resulted in a major reduction of readmissions. We compared patients readmitted after an index AECOPD admission with non-readmitted patients. Patients’ age, gender, body mass index, comorbidities (obstructive sleep apnea, chronic hypercapnia, congestive heart failure, lung cancer, pulmonary arterial hypertension, pneumonia, interstitial lung disease, atrial fibrillation, musculoskeletal disorders, cognitive disorders, and anxiety disorders), substance abuse and smoking status were assessed. Some 272 patients were included: 20 patients were readmitted within 30 days of their index hospitalization; 252 patients were not readmitted within 30 days of their index admission. Readmitted patients were significantly more likely to have pneumonia than non-readmitted patients (30.0% versus 13.1%, p<0.05). No statistically significant difference was seen with respect to other clinical comorbidities. Patients readmitted within 30 days were significantly more likely than non-readmitted patients to have safety issues at home (80.0% versus. 39.3%, p<0.001), anxiety (60.0% versus 29.8%, p<0.01), and lack of transportation (35.0% versus 15.5%, p<0.05). Implementation of a comprehensive care management program (CCMP) was associated with a reduction in readmissions from 21.5% to 13.6% (p<0.01, 95% confidence interval [CI] 2.08-12.45). A CCMP can reduce readmissions through attention to social variables, optimization of in-hospital care, improved coordination of pre- and post-discharge, a system to better identify problems after discharge, and an office setup that accommodates same-day visits.

Citation

Citation: Euceda G, Kong W-T, Kapoor A^, Dilauro P, Ogunnaike R, Chronakos J. The effects of a comprehensive care management program on readmission rates after acute exacerbation of COPD at a community-based academic hospital. J COPD F. 2018; 5(3): 185-192. doi: http://doi.org/10.15326/jcopdf.5.3.2017.0177

Keywords

population health, rehospitalization prevention, risk factors for rehospitalization

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Click to read The Effects of a Comprehensive Care Management Program on Readmission Rates After Acute Exacerbation of COPD at a Community-Based Academic Hospital

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Author Affiliations

1. Emeritus Professor of Medicine, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire

2. Valley Regional Hospital, Claremont, New Hampshire
3. Medical Dynamics, New York, New York
4. University of Louisville, Louisville, Kentucky
5. Rockpile Strategies LLC, LaGrange, Illinois

Address correspondence to:

Donald A. Mahler, MD
Valley Regional Hospital
243 Elm Street
Claremont, NH 03743
Phone: 603 277-0383
Email: mahlerdonald@gmail.com

Abstract

Background: Little is known about patients’ use of the internet to search for information about chronic obstructive pulmonary disease (COPD) and their perspectives on disease content on websites.

Objectives: Todetermine the interests and behavior of patients with COPD who search the internet for disease information and to assess their perspectives about 2 COPD educational websites.

Methods: Individuals with COPD who had registered for a consumer panel were invited electronically to participate in a survey which included general use of the internet, online health behaviors about COPD, and assessment of 2COPD educational websites.

Results: A total of 445 respondents completed the survey in 23 ± 12 minutes (72% response rate). A total of 95% reported that physicians were the primary source of information about COPD followed by internet searches about the disease (76%). The 3 major information priorities were “symptom control” (82%), “how COPD is affecting my body” (60%), and “treatments that might work better for me” (59%). Overall ratings (range, 1 – 10) were 7.4 ± 1.5 for the American Lung Association and 6.8 ±1.8 for the COPD Foundation websites. Ratings by respondents were higher for all 5 impression attributes and for 8 of 9 content attributes on the American Lung Association website compared with the COPD Foundation website.

Conclusions: This report describes, for the first time, information priorities of patients with COPD about their disease and their assessment of 2 educational websites. Our survey results can be used by health care professionals to recommend online resources to their patients.

Citation

Citation: Mahler DA, Cerasoli F, Della L, Rudzinski M. Internet health behaviors of patients with chronic obstructive pulmonary disease and assessment of two disease websites. J COPD F. 2018; 5(3): 158-166. doi: http://doi.org/10.15326/jcopdf.5.3.2017.0173

Keywords

COPD, exacerbations, internet.chronic obstructive pulmonary disease, COPD websites, breathlessness

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Click to read Internet Health Behaviors of Patients with Chronic Obstructive Pulmonary Disease and Assessment of Two Disease Websites

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Author Affiliations

1. Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania
2. Division of Biostatistics and Bioinformatics, Bloomberg School of Health, Johns Hopkins University, Baltimore, Maryland
3. Division of Pulmonary and Critical Care Medicine, School of Medicine, Louisiana State University, New Orleans
4. Channing Laboratory, Brigham and Women’s Hospital and Division of Pulmonary and Critical Care Medicine, Harvard Medical School, Boston, Massachusetts
5. Division of Pulmonary and Critical Care Medicine, School of Medicine, University of California- San Diego
6. Division of Pulmonary and Critical Care Medicine, School of Medicine, University of Colorado, Denver
7. Members of the LOTT Research Group and their affiliations are listed in the Acknowledgements section of this article.

Address correspondence to:

Erin R. Narewski, DO
Department of Thoracic Medicine and Surgery
Lewis Katz School of Medicine
Temple University
3401 North Broad Street
Philadelphia, PA 19140
Erin.Narewski@tuhs.temple.edu

Abstract

Background: Chronic obstructive pulmonary disease (COPD) patients enrolled into the Long-term Oxygen Treatment Trial had hypoxemia at rest, hypoxemia on exertion, or hypoxemia both at rest and on exertion. We hypothesized that patients with different patterns of hypoxemia may have significant differences in clinical features.

Methods: All patients had COPD and oxygen saturation measured by pulse oximetry (blood oxygenation [SpO₂]) at rest and during the 6-minute walk test (6MWT). Hypoxemia at rest was defined as resting SpO₂ between 89-93%. SpO₂ < 90% for at least 10 seconds and ³ 80% for at least 5 minutes during ambulation characterized hypoxemia on exertion. Severe exercise hypoxemia (< 80% for > 1 minute) was exclusionary.

Results: Of 738 patients studied, 133 (18.0%) had mild-moderate hypoxemia at rest only, 319 (43.2%) had hypoxemia on exertion only, and 286 (38.8%) had hypoxemia at both rest and exertion. Patients with hypoxemia at rest only were more likely to be current smokers, had higher body mass index (BMI) and a higher incidence of self-reported diabetes. Patients with hypoxemia on exertion only were more severely obstructed compared to the other groups. General and disease-specific quality of life scores were similarly impaired in all groups. Quality of well-being scores were more impaired in those with hypoxemia at rest only.

Conclusions: COPD patients with mild-moderate hypoxemia have distinct clinical characteristics based on the pattern of oxygen desaturation at rest and with exertion.

Citation

Citation: Narewski ER, Blackford AL, Lammi MR, et al; for the Long-term Oxygen Treatment Trial Research Group. Clinical differences in COPD patients with variable patterns of hypoxemia. J COPD F. 2018; 5(3): 167-176. doi: http://doi.org/10.15326/jcopdf.5.3.2017.0175

Keywords

COPD, chronic obstructive pulmonary disease, long-term oxygen treatment, Long-term Oxygen Treatment Trial, LOTT

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Click to read Clinical Differences in COPD Patients with Variable Patterns of Hypoxemia

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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. Stem cell therapy for COPD: where are we? J COPD F. 2018; 5(2): 148-153. doi: http://doi.org/10.15326/jcopdf.5.2.2018.0140

Keywords

There are no keywords for this article.

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Click to read Stem Cell Therapy for COPD: Where are we?

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Author Affiliations

1. Department of Radiology, Mount Sinai Medical Center, New York, New York
2. Columbia University Medical Center, New York, New York

Address correspondence to:

Mary Salvatore, MD
Department of Radiology
Mount Sinai Medical Center
1 Gustave L. Levy Place
New York, NY 10029
mary.salvatore@mountsinai.org

Abstract

This article does not contain an abstract.

Citation

Citation: Salvatore M, Kwon K, Steiner RM. Images in COPD: combined pulmonary fibrosis and emphysema. J COPD F. 2018; 5(2): 154-157. doi: http://doi.org/10.15326/jcopdf.5.2.2018.0137

Keywords

COPD, chronic obstructive pulmonary disease, combined pulmonary fibrosis and emphysema, CPFE, idiopathic pulmonary fibrosis, IPF

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Click to read Combined Pulmonary Fibrosis and Emphysema

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Author Affiliations

1. St. Francis Hospital and University Medical Research LLC

Address correspondence to:

Nicholas Gross, MD, PhD
Grossnicholas1@gmail.com

Abstract

This article does not contain an abstract.

Citation

Citation: Gross N. COPD pipeline XXXVII. J COPD F. 2018; 5(2): 144-147. doi: http://doi.org/10.15326/jcopdf.5.2.2018.0136

Keywords

INS1007, Pioneer, doxofylline, QVA, Gala treatment, Nemiralisib, CHI3L1, YKL-40

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Click to read The COPD Pipeline XXXVIII

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Author Affiliations

1. Pneumology and Critical Care Medicine, Thoraxklinik at University of Heidelberg, Heidelberg, Germany
2. Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany

Address correspondence to:

Daniela Gompelmann, MD
Phone: 004962213968087
Email: daniela.gompelmann@med.uni-heidelberg.de

Abstract

This article does not contain an abstract.

Citation

Citation: Gompelmann D. Editorial: Hope for patients with homogeneous emphysema? J COPD F. 2018; 5(2): 84-86. doi: http://doi.org/10.15326/jcopdf.5.2.2018.0135

Keywords

COPD, chronic obstructive pulmonary disease, lung volume reduction surgery, endobronchial coils, homogeneous emphysema, LVRS

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Click to read Hope for Patients with Homogeneous Emphysema?

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Author Affiliations

1. Department of Biomedical Sciences, College of Medicine, Inha University, Incheon, Republic of Korea
2. Channing Division of Network Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
3. Division of Pulmonary and Critical Care Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
4. Department of Medicine, National Jewish Health, Denver, Colorado
5. School of Public Health, University of Colorado, Denver
6. University of Pittsburgh, Pittsburgh, Pennsylvania

Address correspondence to:

Elizabeth A. Regan, MD
1400 Jackson St, K706
Denver, CO 80209
Email: ReganE@NJHealth.org
Phone: 303-398-1531
Fax: 303-270-2249

Abstract

Background: Adiponectin has been proposed as a biomarker of disease severity and progression in chronic obstructive pulmonary disease (COPD) and associated with spirometry-defined COPD and with computed tomography (CT)-measured emphysema. Increased adiponectin plays a role in other diseases including diabetes/metabolic syndrome, cardiovascular disease and osteoporosis. Previous studies of adiponectin and COPD have not assessed the relationship of adiponectin to airway disease in smokers and have not evaluated the effect of other comorbid diseases on the relationship of adiponectin and lung disease. We postulated that adiponectin levels would associate with both airway disease and emphysema in smokers with and without COPD, and further postulated that body composition and the comorbid diseases of osteoporosis, cardiovascular disease and diabetes might influence adiponectin levels.

Methods: Current and former smokers from the COPD Genetic Epidemiology study (COPDGene) (n= 424) were assigned to 4 groups based on CT lung characteristics and volumetric Bone Density (vBMD). Emphysema (% low attenuation area at -950) and airway disease (Wall area %) were used to assess smoking-related lung disease (SRLD). Group 1) Normal Lung with Normal vBMD; Group 2) Normal Lung and Osteoporosis; Group 3) SRLD with Normal vBMD; Group 4) SRLD with Osteoporosis. Cardiovascular disease (CVD), diabetes, C-reactive protein (CRP) and T-cadherin (soluble receptor for adiponectin) levels were defined for each group. Body composition was derived from chest CT. Multivariable regression assessed effects of emphysema, wall area %, bone density, comorbid diseases and other key factors on log adiponectin.

Results: Group 4, SRLD with Osteoporosis, had significantly higher adiponectin levels compared to other groups and the effect persisted in adjusted models. Systemic inflammation (by CRP) was associated with SRLD in Groups 3 and 4 but not with osteoporosis alone. In regression models, lower bone density and worse emphysema were associated with higher adiponectin. Airway disease was associated with higher adiponectin levels when T-cadherin was added to the model. Male gender, greater muscle and fat were associated with lower adiponectin.

Conclusions: Adiponectin is increased with both airway disease and emphysema in smokers. Bone density, and fat and muscle composition are all significant factors predicting adiponectin that should be considered when it is used as a biomarker of COPD. Increased adiponectin from chronic inflammation may play a role in the progression of bone loss in COPD and other lung diseases.

Citation

Citation: Suh YJ, McDonald M-LN, Washko GR, et al; for the COPDGene Investigators. Lung, fat and bone: increased adiponectin with the combination of smoking-related lung disease and osteoporosis. J COPD F. 2018; 5(2): 134-143. doi: http://doi.org/10.15326/jcopdf.5.2.2016.0174

Keywords

COPD, emphysema, body composition, adiponectin, osteoporosis, airway disease, smoking-related lung disease, QCT, volumetric BMD, bone mineral density, T cadherin, CDH13, C-reactive protein, systemic inflammation, muscle area, pectoralis, subcutaneous fat area, visceral fa

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Author Affiliations

1. Graduate Medical Education, Arnot Ogden Medical Center, Elmira, New York

Address correspondence to:

James Tasch, DO
600 Roe Ave
Elmira, New York 14905
Phone: 607-737-4100
Email: james.tasch@steward.org

Abstract

Chronic obstructive pulmonary disease (COPD) currently affects more than 16 million Americans and it is estimated that roughly 100,000 Americans have undiagnosed, severe alpha-1 antitrypsin deficiency (AATD) (Chest. 2005;128[3]:1179-1186) (Chest. 2002;122[5]:1818-1829). Patients with AATD have an accelerated rate of decline of lung function caused by proteolytic enzymes. The morbidity associated with this inherited disorder is preventable due to the availability of augmentation therapy. Appropriate inpatient screening of patients with COPD for AATD is lacking and most screening is exclusively limited to outpatient pulmonary clinics. Between May 2016 and February 2017, genetic screening was completed on 54 individuals who were admitted with either a former diagnosis of COPD or active COPD exacerbation to Arnot Ogden Medical Center (AOMC) in Elmira, New York. The incorporation of inpatient genetic screening by resident physicians for AATD in COPD patients led to a high rate of screened and newly diagnosed AATD carriers with a variety of AATD genotypes. It is recommended that there should be an expansion of screening for AATD in hospitalized patients with COPD, regardless of age or smoking history.

Citation

Citation: Tasch JJ, McLaughlan AT, Nasir AA. A novel approach to screening for alpha-1 antitrypsin deficiency: inpatient testing at a teaching institution. J COPD F. 2018; 5(2): 106-110. doi: http://doi.org/10.15326/jcopdf.5.2.2017.0170

Keywords

COPD, chronic obstructive pulmonary disease, alpha-1 antitrypsin deficiency, inpatient, AAT, genetic screening, resident physician, AAT carriers

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