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Cara B. Pasquale, MPH1 Jeffrey Vietri, PhD2 Radmila Choate, MPH3 Angee McDaniel, PharmD4 Reiko Sato, PhD2 Kimbal D. Ford, PharmD5 Elisha Malanga, BS1 Barbara P. Yawn, MD, MSc1
Author Affiliations
- Research Department, COPD Foundation, Inc., Washington, D.C.
- Patient & Health Impact, Pfizer, Inc., Collegeville, Pennsylvania
- College of Public Health, University of Kentucky Lexington, and Consultant, COPD Foundation, Inc.
- Medical Affairs, Pfizer, Inc., Columbia, Missouri
- Medical Affairs, Pfizer, Inc., Lexington, Kentucky
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. Chronic Obstr Pulm Dis. 2019; 6(2): 132-144. doi: http://dx.doi.org/10.15326/jcopdf.6.2.2018.0144
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Edward Eden, MBBS1 Radmila Choate, MPH2 Alan Barker, MD3 Doreen Addrizzo-Harris, MD4 Timothy R. Aksamit, MD5 Charles L. Daley, MD6 M. Leigh Anne Daniels, MD, MPH7 Angela DiMango, MD8 Kevin Fennelly, MD9 David E. Griffith, MD10 Margaret M. Johnson, MD11 Michael R. Knowles, MD7 Mark L. Metersky, MD12 Peadar G. Noone, MD7 Anne E. O’Donnell, MD13 Kenneth N. Olivier, MD, MPH9 Matthias A. Salathe, MD14 Andreas Schmid, MD15 Byron Thomashow, MD8 Gregory Tino, MD16 Gerard M. Turino, MD1 Kevin L. Winthrop, MD, MPH3,17
Author Affiliations
- Icahn School of Medicine Mt Sinai, New York, New York
- University of Kentucky College of Public Health, Lexington
- Oregon Health Sciences University Hospital, Portland
- New York University School of Medicine, New York
- Pulmonary Disease and Critical Care Medicine, Mayo Clinic, Rochester, Minnesota
- Division of Mycobacterial and Respiratory Infections, National Jewish Health, Denver, Colorado
- University of North Carolina at Chapel Hill
- Columbia College of Physicians and Surgeons, Center for Chest Disease, New York, New York
- National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland
- University of Texas at Tyler
- Mayo Clinic Florida, Pulmonary and Critical Care, Jacksonville
- Division of Pulmonary and Critical Care Medicine, University of Connecticut School of Medicine, Farmington
- Georgetown University Medical Center, Washington, DC
- University of Kansas Medical School, Kansas City
- University of Miami Miller School of Medicine, Miami, Florida
- University of Pennsylvania Perelman School of Medicine, Philadelphia
- 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 10th 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. Chronic Obstr Pulm Dis. 2019; 6(2): 145-153. doi: http://dx.doi.org/10.15326/jcopdf.6.2.2018.0156
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Gary T. Ferguson, MD1 Gregory Feldman, MD2 Krishna K. Pudi, MD3 Chris N. Barnes, PhD4 Edmund J. Moran, PhD4 Brett Haumann, MD, MBA4 Srikanth Pendyala, MD4 Glenn Crater, MD4
Author Affiliations
- Pulmonary Research Institute of Southeast Michigan, Farmington Hills
- South Carolina Pharmaceutical Research, Spartanburg
- Sherman Clinical Research, Sherman, Texas
- 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. Chronic Obstr Pulm Dis. 2019; 6(2): 154-165. doi: http://dx.doi.org/10.15326/jcopdf.6.2.2018.0152
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