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Matthew Moll, MD1,2 Elizabeth A. Regan, MD, PhD3 John E. Hokanson, PhD4 Sharon M. Lutz, PhD5 Edwin K. Silverman, MD, PhD1,2,6 James D. Crapo, MD7 Barry J. Make, MD7 Dawn L. DeMeo, MD, MPH1,2
Author Affiliations
- Channing Division of Network Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
- Division of Pulmonary and Critical Care Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
- Division of Rheumatology, National Jewish Health, Denver, Colorado
- Department of Epidemiology, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora
- PRecisiOn Medicine Translational Research (PROMoTeR) Center, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care, Boston, Massachusetts
- Harvard Medical School, Boston, Massachusetts
- Division of Pulmonary, Critical Care and Sleep Medicine, National Jewish Health, Denver, Colorado
Address correspondence to:
Dawn L. DeMeo, MD, MPH
Harvard Medical School
Brigham and Women’s Hospital
Phone: (617) 525-0866
Email: dawn.demeo@channing.harvard.edu
Abstract
Background: Apparent increased female susceptibility to chronic obstructive pulmonary disease (COPD) suggests sex hormones modulate disease pathogenesis. Little is known about associations between multiparity and lung function in smokers.
Research Question: We hypothesized that multiparity is associated with lung function and measures of emphysema and airway disease.
Study Design and Methods: Utilizing female participants from the 5-year follow up of the COPD Genetic Epidemiology (COPDGene®) study we performed multivariable linear regressions to assess the effect of multiparity and number of pregnancies on forced expiratory volume in 1 second (FEV1) percentage of predicted (% predicted), FEV1/forced vital capacity (FVC), percent emphysema on computed tomography (CT) scans, and Pi10, a measure of airway thickening. We sampled never smokers and those with lower smoking exposure from the National Health and Nutrition Examination Survey (NHANES) 2011-2012 dataset.
Results: We included 1820 participants from COPDGene® and 418 participants from NHANES (321 never smokers, 97 ever smokers). In COPDGene®, multiparity (beta coefficient [β] = -3.8, 95% confidence interval [CI]: [-6.5, -1.1], p = 0.005) and higher number of pregnancies were associated with lower FEV1 % predicted. Multiparity was not associated with percent emphysema or Pi10. In individuals with no or mild obstruction, multiparity was associated with lower FEV1 % predicted. There was an interaction with multiparity and age on FEV1 % predicted (p = 0.025). In NHANES, there was no association between multiparity and FEV1 % predicted in never smokers or the lower smoking exposure group.
Interpretation: Multiparity was associated with lower FEV1 % predicted in current and former smokers in COPDGene® study participants. These preliminary results emphasize the importance of smoking abstinence in women of child-bearing age.
Citation
Citation: Moll M, Regan EA, Hokanson JE, et al. The association of multiparity with lung function and chronic obstructive pulmonary disease-related phenotypes. Chronic Obstr Pulm Dis. 2020; 7(2): 86-98. doi: http://dx.doi.org/10.15326/jcopdf.7.2.2019.0166
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Thomas M. Siler, MD1 Edmund J. Moran, PhD2 Chris N. Barnes, PhD2 Glenn D. Crater, MD2
Author Affiliations
- Midwest Chest Consultants, PC, St Charles, Missouri
- Theravance Biopharma US, Inc., South San Francisco, California
Abstract
Although no nebulized, dual mechanism, long-acting bronchodilator is currently marketed, with the approval of once-daily long-acting muscarinic antagonist (LAMA) revefenacinefenacin, it is theoretically possible to deliver a LAMA and long-acting beta2-agonist via standard jet nebulizer. The primary and secondary objectives of our study were to characterize the safety profile of revefenacin administered sequentially before or in combination with formoterol, via standard jet nebulizer in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). In this randomized, double-blind, 42-day trial (NCT03573817), patients received revenacin 175 µg (n=63) or placebo (n=59), followed by formoterol 20 µg in the morning and formoterol alone in the evening formoterol 21 days via standard jet nebulizer (sequential administration). For another 21 days, revefenacin/placebo and formoterol, were administered as mixed solutions via single nebulization in the morning (combined administration), and formoterol alone in the evening. The adverse events’ (AEs) incidence was higher in the placebo + formoterol arms (11%–12%) than in the revefenacin + formoterol arms (5%–8%). The most common AEs were worsening/exacerbation of COPD, cough, and dizziness. There were no serious AEs or deaths reported in any arm. The least squares mean in trough forced expiratory volume in 1 second (FEV1) versus baseline was higher in the revefenacin + formoterol arms (116–157 mL) than in the placebo + formoterol arms (35–53 mL). Revefenacin had a safety profile similar to formoterol alone when delivered sequentially or combined. Trough FEV1 was similar when revefenacin was delivered sequentially or combined with formoterol, with revefenacin providing an additional 81–104 mL improvements over formoterol alone.
Citation
Citation: Siler TM, Moran EJ, Barnes CN, Crater GD. Safety and efficacy of revefenacin and formoterol in sequence and combination via a standard jet nebulizer in patients with chronic obstructive pulmonary disease: a phase 3b, randomized, 42-day study. Chronic Obstr Pulm Dis. 2020; 7(2): 99-106. doi: http://dx.doi.org/10.15326/jcopdf.7.2.2019.0154
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Trisha M. Parekh, DO1 Andrea L. Cherrington, MD, MPH2 Smita Bhatia, MD, MPH3 Bulent Turan, PhD4 Siddharth B. Patel, MBBS, MPH5 Young-il Kim, PhD1 Janet M. Turan, PhD6 Mark T. Dransfield, MD1,7
Author Affiliations
- Division of Pulmonary, Allergy, and Critical Care, Department of Medicine, University of Alabama at Birmingham
- Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham
- Institute for Cancer Outcomes and Survivorship, University of Alabama at Birmingham
- Department of Psychology, University of Alabama at Birmingham
- Lung Health Center, University of Alabama at Birmingham
- Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham
- Birmingham VA Medical Center, Birmingham, Alabama
Address correspondence to:
Trisha Parekh, DO
1900 University Blvd, THT 422-433
Birmingham, AL 35294
Phone: (205) 934-5555
Email: trishaparekh@uabmc.edu
Abstract
Introduction: Low-income chronic obstructive pulmonary disease (COPD) individuals are known to have higher rates of COPD-related hospitalizations and readmissions. Levels of psychological stress are also higher in low-income populations and may be associated with acute care use. We sought to: (1) determine the association between stress and acute care use in COPD, (2) evaluate the social determinants of health (SDH) in low and high stress individuals, and (3) determine the association between low income and high stress with acute care use.
Materials and Methods: Using results from a survey-based study of individuals with COPD at the University of Alabama (UAB), we used multivariable regression modeling to evaluate the association of high stress with acute care use (COPD-related emergency department [ED] visits or hospitalizations). We then compared SDH between low and high stress groups and evaluated the association of low income + high stress with acute care use in a secondary model.
Results: We included 126 individuals in our study. The high stress group was more likely to be < 65 years old and female. No differences in race, smoking, years of smoking, body mass index, dyspnea, or lung function (forced expiratory volume in 1 second [FEV1]%) by stress group were observed. The high stress group had a 2.5-fold increased adjusted odds of acute care use (adjusted odds ratio [AOR]95% confidence interval [CI], 2.51, 1.06–5.98) compared to the low stress group, while the low-income + high stress group had a 4-fold increased adjusted odds of acute care use (AOR, 95% CI, 4.38, 1.25–15-45) compared to high-income + low-stress group.
Conclusions: Acute care use and stress are associated in COPD. These associations are more pronounced in the low-income + high stress population who disproportionately contribute to health care utilization and frequently lack the resources needed to cope with stress.
Citation
Citation: Parekh TM, Cherrington AL, Bhatia S, et al. The association of low income and high stress with acute care use in COPD patients. Chronic Obstr Pulm Dis. 2020; 7(2): 107-117. doi: http://dx.doi.org/10.15326/jcopdf.7.2.2019.0165
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Edward M. Kerwin, MD1 Selwyn Spangenthal, MD2 Michael Zvarich, MSc, MBA3 Valerie Millar, MSc4 Renu Jain, PhD3 Kathryn Collison, MPH, PMP3 Raj Sharma, MD5
Author Affiliations
- Clinical Research Institute of Southern Oregon, Medford
- American Health Research, Charlotte, North Carolina
- GlaxoSmithKline plc., Research Triangle Park, Durham, North Carolina
- GlaxoSmithKline plc., Uxbridge, United Kingdom
- Respiratory Medical Franchise, GlaxoSmithKline plc., Brentford, United Kingdom
Address correspondence to:
Edward M. Kerwin, MD
Clinical Research Institute of Southern Oregon
3860 Crater Lake Ave
Medford, OR 97504
Phone: (541) 858-1003
Email: ekerwin@criresearch.com
Abstract
Background: Inhaler errors among patients with chronic obstructive pulmonary disease (COPD) can reduce treatment efficacy.
Methods: This randomized, open-label, crossover study evaluated correct use of ELLIPTA versus DISKUS plus HandiHaler. Participants with COPD attended at least 3 study visits (Day 1 [Visit 1], Day 28 [Visit 2], and Day 56 [Visit 3]). Inhalers contained placebo; usual maintenance medication was continued. Participants were randomized to an inhaler sequence (ELLIPTA then DISKUS plus HandiHaler, or the reverse) and preference questionnaire at Visit 1. Participants read the instructions for use in the approved prescribing information for their inhaler(s) and correct use was assessed at Visit 1 (verbal guidance provided if required). Correct use was reassessed at Visit 2, and with the next inhaler(s) at Visit 3. Primary endpoint was the proportion of participants demonstrating correct use (0 errors) with the assigned inhaler(s) after 28 days.
Results: A greater proportion of study participants (n = 217) correctly used ELLIPTA (96%) versus DISKUS plus HandiHaler (87%) after 28 days. The odds of demonstrating correct use with ELLIPTA were 6.88 times that of DISKUS plus HandiHaler (p < 0.001). Overall, > 99% of participants made 0 critical errors (errors leading to no or significantly reduced medication inhaled) with ELLIPTA versus 89% with DISKUS plus HandiHaler after 28 days. ELLIPTA was the patient-preferred option versus DISKUS plus HandiHaler or no preference (p < 0.001).
Conclusions: Delivery of COPD maintenance therapy via ELLIPTA demonstrates higher correct use rates and lower critical error rates compared with DISKUS plus HandiHaler.
Citation
Citation: Kerwin EM, Spangenthal S, Zvarich M, et al. ELLIPTA versus DISKUS plus HANDIHALER in COPD: a randomized, open-label, crossover study in a clinical trial setting. Chronic Obstr Pulm Dis. 2020; 7(2): 118-129. doi: http://dx.doi.org/10.15326/jcopdf.7.2.2019.0153
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