Author Affiliations

1. Editor in Chief, Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation
2. National Jewish Health, Denver, Colorado

Address correspondence to:

James D. Crapo, MD
Email: crapoj@njhealth.org

Abstract

This article does not contain an abstract.

Citation

Citation: Crapo JD. Editorial: fifty years of the Division of Lung Diseases and the evolution of pulmonary research and medicine.

Keywords

COPD, chronic obstructive pulmonary disease, NHLBI, National Heart Lung and Blood Institute, Division of Lung Diseases, DLD, pulmonary research, pulmonary training, history of pulmonary research

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Author Affiliations

1. Advance Health Solutions, New York, New York
2. School of Professional Studies, Columbia University, New York, New York
3. Harvard Medical School and Chronic Obstructive Pulmonary Disease Center, Brigham and Women’s Hospital, Boston, Massachusetts
4. Department of Family Medicine and Public Health, Division of Health Policy, University of California San Diego, La Jolla
5. Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts

Address correspondence to:

Maryam Navaie, DrPH, MBA
Advance Health Solutions, LLC
5 Penn Plaza, 23rd Floor
New York, NY 10001
Phone : (212) 835-1510
E-mail: mnavaie@advancehealthsolutions.com

Abstract

Background: Long-acting beta2-agonists (LABAs), with or without inhaled corticosteroids (ICSs), delivered by handheld inhalers or nebulizers are recommended as maintenance therapy in chronic obstructive pulmonary disease (COPD). This study evaluated exacerbations, health resource utilization (HRU), and costs among Medicare beneficiaries with COPD on handheld ICS+LABA who switched to nebulized arformoterol (ARF) or continued ICS+LABA following a respiratory event.

Methods: Using Medicare claims, we identified beneficiaries with COPD (international classification of disease, 9th revision, clinical modification [ICD-9-CM] 490-492.xx, 494.xx, 496.xx) between 2010-2014 who had ≥ 1 year of continuous enrollment in Parts A, B, and D; ≥ 2 COPD-related outpatient visits ≥ 30 days apart or ≥ 1 hospitalization(s); ICS+LABA use 90-days before ARF initiation; and a respiratory event (COPD-related hospitalization or emergency department [ED] visit < 30 days before ARF initiation). Using propensity scores, 423 beneficiaries who switched to ARF were matched to 423 beneficiaries who continued on handheld ICS+LABA (controls). Difference-in-difference regression models examined outcomes at 180-days follow-up.

Results: Beneficiaries who switched to ARF had 1.5 fewer exacerbations (p=0.015) but no difference in hospitalizations and ED visits compared to controls. Durable medical equipment (DME) costs were higher among ARF users than controls ($1590), yet total health care costs were similar due to cost offsets by ARF in pharmacy (-$794), inpatient (-$524), and outpatient care (-$65). ARF accounted for 55% ($886.63) of DME costs, with the remaining costs attributed to oxygen therapy ($428.10) and nebulized corticosteroids ($590.85).

Conclusions: Switching from handheld ICS+LABA to nebulized ARF resulted in fewer COPD exacerbations among Medicare beneficiaries. Nebulized LABAs may improve outcomes in selected patients with COPD.

Citation

Citation: Navaie M, Celli BR, Xu Z, Cho-Reyes S, Dembek C, Gilmer TP. Exacerbations, health resource utilization, and costs among Medicare beneficiaries with chronic obstructive pulmonary disease treated with nebulized arformoterol following a respiratory event.

Keywords

chronic obstructive pulmonary disease, exacerbations, hospitalization, long-acting beta2-agonists, Medicare, nebulized therapy, arformoterol, health resource utilization, costs, durable medical equipment

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Author Affiliations

1. Geisel School of Medicine at Dartmouth, Hanover, New Hampshire
2. Clinical Research Institute of Southern Oregon, Medford, Oregon
3. Evidera, Bethesda, Maryland
4. Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts

Address correspondence to:

Carole Dembek
Sunovion Pharmaceuticals Inc.
84 Waterford Drive
Marlborough, MA 01752
Phone: +1 508-357-7704
Email: carole.dembek@sunovion.com

Abstract

Background: Chronic cough, dyspnea, and excessive sputum production, the characteristic symptoms of chronic obstructive pulmonary disease (COPD), can negatively affect patients’ health-related quality of life (HRQoL). The fixed-dose combination of a long-acting beta2-adrenergic agonist and a long-acting muscarinic antagonist (LABA/LAMA) have been shown to improve HRQoL and COPD symptoms as measured by the St George’s Respiratory Questionnaire (SGRQ) and the Transition Dyspnea Index (TDI) total scores. However, the impact of a LABA/LAMA on the individual components of HRQoL and dyspnea with daily activities is unknown.

Methods: Secondary analysis of pooled data from 2 replicate, phase 3, 12-week, randomized, placebo, and active-controlled trials of twice-daily indacaterol/glycopyrrolate (IND/GLY) were analyzed. Change from baseline in HRQoL and dyspnea was measured by SGRQ and TDI, respectively. Total and component scores were evaluated using linear mixed models. Logistic regression was used to analyze the proportion of patients achieving minimum clinically important difference. Study outcomes were further explored in patient subgroups.

Results: A total of 2038 patients from FLIGHT1/FLIGHT2 studies were evaluated. IND/GLY significantly improved SGRQ component scores (symptoms [–7.3], activity [–3.6], and impacts [–5.0]); all P < 0.001 compared with placebo. IND/GLY also significantly improved symptoms scores compared with IND and GLY (–3.5 and –3.7, respectively; both P < 0.001). Patients treated with IND/GLY also had significant improvements in TDI component scores compared with placebo: functional impairment (0.48), magnitude of task (0.61), and magnitude of effort (0.54); all P < 0.001. All component scores were significantly higher for IND/GLY compared with IND and GLY (P ≤ 0.002 for all).

Conclusions: Twice-daily IND/GLY significantly improved total scores as well as components of HRQoL and dyspnea in patients with COPD. These data demonstrate multiple clinical benefits of LABA/LAMA maintenance therapy in the COPD population.

ClinicalTrials.gov: NCT 01727141 and NCT 01712516

Citation

Citation: Mahler DA, Kerwin E, Murray L, Dembek C. The impact of twice-daily indacaterol/glycopyrrolate on the components of health-related quality of life and dyspnea in patients with moderate-to-severe chronic obstructive pulmonary disease.

Keywords

chronic obstructive pulmonary disease, Transition Dyspnea Index, St George’s Respiratory Questionnaire, health-related quality of life, indacaterol/glycopyrrolate

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Click to read The Impact of Twice-Daily Indacaterol/Glycopyrrolate on the Components of Health-Related Quality of Life and Dyspnea in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease

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Author Affiliations

1. Geisel School of Medicine at Dartmouth, Hanover, New Hampshire and Respiratory Services, Valley Regional Hospital, Claremont, New Hampshire
2. Wake Forest University Medical Center, Winston-Salem, North Carolina
3. Theravance Biopharma US, Inc., South San Francisco, California

Address correspondence to:

Glenn Crater, MD
Phone: 650-808-4078
Email: gcrater@theravance.com

Abstract

Background: Patients with chronic obstructive pulmonary disease (COPD) and suboptimal peak inspiratory flow rate (sPIFR) may not benefit optimally from dry powder inhalers (DPI) because of inadequate inspiratory flow. Nebulized bronchodilators may provide a better alternative. We compared bronchodilation with the long-acting muscarinic antagonist (LAMA) revefenacin for nebulization versus the DPI LAMA tiotropium, in patients with COPD and sPIFR (< 60 L/min against the resistance of Diskus^®).

Methods: This was a randomized, double-blind, double-dummy, 28-day Phase 3b study in patients with COPD enrolled based on sPIFR. The primary endpoint was trough forced expiratory volume in 1 second (FEV₁) on Day 29 for revefenacin for nebulization versus tiotropium HandiHaler^® DPI.

Results: We enrolled 206 patients with mean (standard deviation) age, 65 (8) years; percent predicted FEV₁, 37 (16)%; PIFR, 45 (12) L/min. In the intent-to-treat (ITT) population, revefenacin improved trough FEV₁ from baseline; however, the difference versus tiotropium was not significant (least squares [LS] mean difference [standard error], 17.0 [22.4] mL, P=0.4461). In a prespecified analysis of patients with FEV₁ < 50% predicted, revefenacin produced an LS mean difference (95% confidence interval [CI]), 49.1 (6.3—91.9) mL in trough FEV₁ and 103.5 (7.7—199.3) mL in forced vital capacity versus tiotropium. Revefenacin produced >100 mL increase in FEV₁ in 41.6% versus 34.4% of patients with tiotropium in ITT and 41.4% versus 25.7% of patients in FEV₁ < 50% predicted populations.

Conclusions: Revefenacin did not produce significant improvements in FEV₁ versus tiotropium in the ITT population, but increased trough FEV₁ in patients with FEV₁ < 50% predicted and sPIFR.

Clinical Trial Registration (www.Clinicaltrials.gov): Study 0149 (NCT03095456)

Citation

Citation: Mahler DA, Ohar JA, Barnes CN, Moran EJ, Pendyala S, Crater GD. Nebulizedversus dry powder long-acting muscarinic antagonist bronchodilators in patients with COPD and suboptimal peak inspiratory flow rate.

Keywords

tiotropium, long-acting muscarinic antagonist, peak inspiratory flow rate, dry powder inhalers, nebulizers

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Click to read Nebulized Versus Dry Powder Long-Acting Muscarinic Antagonist Bronchodilators in Patients With COPD and Suboptimal Peak Inspiratory Flow Rate

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Author Affiliations

1. University of Illinois at Chicago
2. Los Angeles Biomedical Research Institute at Harbor-University of California-Los Angeles Medical Center, Torrance
3. Portland VA Medical Center, Portland, Oregon
4. Johns Hopkins University, Baltimore, Maryland
5. Institute for Healthcare Delivery Design, University of Illinois Hospital and Health Sciences System, Chicago

Address correspondence to:

Valentin Prieto-Centurion, MD, MS
University of Illinois at Chicago
1220 S. Wood St, MC 619
Chicago, IL 60608
Phone: (312) 413-1960
Email: vprieto@uic.edu

Abstract

Background: Low physical activity in patients with chronic obstructive pulmonary disease (COPD) is associated with increased morbidity and mortality. To inform the design of a home-based physical activity promotion program for patients with COPD recently discharged from a minority-serving hospital, we conducted a cohort study to evaluate objectively measured daily physical activity and patient-reported outcomes.

Methods: This was a 12-week prospective cohort study of patients with a physician diagnosis of COPD recently hospitalized (≤ 12 weeks) for respiratory symptoms. Daily physical activity was recorded using wrist-based and “clip-on” pedometers, and analyzed as mean daily step counts averaged over 7 days.

Results: Twenty-two patients were enrolled a median (interquartile range, [IQR]) of 14 (7 to 29) days after hospital discharge. The median daily step count (IQR) in the first week after enrollment (week 1) was 3710 (1565 to 5129) steps. The median within-person change in daily step count (IQR) from week 1 to week 12 was 314 (-30 to 858) steps (p=0.28). Within-person correlation of week-to-week daily step counts was high (r ≥ 0.75). Time from hospital discharge to enrollment was not correlated with mean daily step counts on week 1 (r= -0.13) and only weakly correlated with change in mean daily step counts from week 1 to week 12 (r=0.37).

Conclusions: Daily physical activity was variable in this cohort of recently hospitalized patients with COPD, but with little within-person change over a 12-week period. These observations highlight the need for flexible physical activity promotion programs addressing the needs of a heterogeneous patient population.

Citation

Citation: Prieto-Centurion V, Casaburi R, Coultas DB, et al. Daily physical activity in patients with COPD after hospital discharge in a minority population.

Keywords

COPD, physical activity, post-hospital discharge

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Author Affiliations

1. Section of Pulmonary, Critical Care, Allergy, and Immunological Diseases, Wake Forest University School of Medicine, Winston-Salem, North Carolina
2. Division of Pulmonary Diseases and Critical Care, Department of Medicine, University of North Carolina, Chapel Hill
3. Internal Medicine & Pulmonology, Charlotte Lung & Health Center, Charlotte, North Carolina

Address correspondence to:

Jill Ohar, MD
Email: johar@wakehealth.edu
Phone: 336-406-6733

Abstract

Chronic obstructive pulmonary disease is the third leading cause of death and disease burden worldwide. It includes a spectrum of diseases including chronic bronchitis which is characterized by overproduction, hypersecretion and decreased elimination of mucus. Chronic bronchitis has numerous clinical consequences, including predisposition to lower respiratory tract infections, accelerated decline in lung function, increased exacerbation rate and decreased health-related quality of life.

Although the inflammatory mechanisms responsible for mucus cell metaplasia in chronic obstructive pulmonary disease and stable chronic bronchitis are poorly understood, the main goals of therapy are to decrease mucus hypersecretion by controlling inflammation and to increase mucus clearance. Non-pharmacological measures include smoking cessation and chest physiotherapy. Pharmacological interventions include expectorants and mucolytics together with long-acting beta2-adrenergic receptor agonists, anticholinergics, glucocorticoids, phosphodiesterase-4 inhibitors, antioxidants, and antibiotics.

Guaifenesin is an expectorant that is thought to increase hydration and decrease viscosity of mucus leading to improved clearance of accumulated secretions from the upper and lower airway. Although guaifenesin has a Food and Drug Administration Over-the-Counter (OFC) Monograph indication to "help loosen phlegm (mucus) and thin bronchial secretions in patients with stable chronic bronchitis," there is limited published evidence of either mechanism of action or clinical efficacy in this disease state. Here we review the pathophysiology and consequences of chronic mucus hypersecretion and examine the evidence for the use of guaifenesin in patients with stable chronic bronchitis.

Citation

Citation: Ohar JA, Donohue JF, Spangenthal S. The role of guaifenesin in the management of chronic mucus hypersecretion associated with stable chronic bronchitis: a comprehensive review.

Keywords

COPD, chronic bronchitis, chronic obstructive pulmonary disease, stable chronic bronchitis, chronic mucus hypersecretion, guaifenesin, expectorants

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Click to read The Role of Guaifenesin in the Management of Chronic Mucus Hypersecretion Associated with Stable Chronic Bronchitis: A Comprehensive Review

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Author Affiliations

1. Department of Preventive Medicine and Environmental Health, University of Kentucky College of Public Health, Lexington

Address correspondence to:

David M. Mannino, MD
Department of Preventive Medicine and Environmental Health
University of Kentucky
College of Public Health
111 Washington Avenue Lexington, KY 40536
Phone: 859 797 2579
E-mail: dmannino@uky.edu

Abstract

Our understanding of the epidemiology of chronic obstructive pulmonary disease (COPD), including such metrics as incidence, prevalence, risk factors, outcome, and comorbidities has increased greatly over the past 50 years. Much of this increase is attributable to National Heart Blood and Lung Institute (NHLBI)-sponsored studies. This paper will review 13 of these key studies and their contribution to our understanding of COPD in the last half century.

Citation

Citation: Mannino DM. Fifty years of progress in the epidemiology of chronic obstructive pulmonary disease: a review of National Heart, Lung, and Blood Institute-sponsored studies.

Keywords

epidemiology, NHLBI, National Heart Lung and Blood Institute, Division of Lung Diseases

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Click to read Fifty Years of Progress in the Epidemiology of Chronic Obstructive Pulmonary Disease: A Review of National Heart, Lung, and Blood Institute-Sponsored Studies

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Author Affiliations

1. Johns Hopkins University School of Medicine, Baltimore, Maryland
2. University of Illinois College of Medicine, Chicago

Address correspondence to:

Robert A. Wise, MD
Johns Hopkins University School of Medicine
5501 Hopkins Bayview Circle
Baltimore, MD 21224
Phone: 410-550-0545
Email: rwise@jhmi.edu

Abstract

The National Institutes of Health (NIH)-National Heart, Lung, and Blood Institute’s (NHLBI) Division of Lung Diseases is celebrating its 50^th anniversary. On this occasion, we are reviewing the major landmark clinical trials that were initiated by the NHLBI’s Division of Lung Disease and that have had substantial impact on our understanding of chronic obstructive pulmonary disease (COPD) and how it is best treated. Although some of these trials did not show hypothesized treatment benefits for COPD, they have enabled clinicians to provide care for individuals with COPD relying on the most rigorous evidence. The 5 trials that are reviewed here are: the Intermittent Positive Pressure Breathing Trial, the Nocturnal Oxygen Treatment Trial, the Lung Health Study, the National Emphysema Treatment Trial, and the Long-term Oxygen Treatment Trial. These clinical trials have not only set the standards for COPD care but have served as models for the state-of-the-art conduct of clinical research in COPD.

Citation

Citation: Wise RA, Krishnan JA. Celebration of the 50-year anniversary of the National Heart, Lung, and Blood Institute Division of Lung Diseases: a half-century of landmark clinical trials.

Keywords

COPD, chronic obstructive pulmonary disease, clinical trials, lung volume reduction surgery, oxygen therapy, smoking cessation, positive pressure breathing

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Click to read Celebration of the 50-Year Anniversary of the National Heart, Lung, and Blood Institute Division of Lung Diseases: A Half-Century of Landmark Clinical Trials

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Author Affiliations

1. Airway Biology and Disease Branch, Division of Lung Diseases, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland

Address correspondence to:

Thomas L. Croxton, PhD, MD
Email: croxtont@nhlbi.nih.gov

Abstract

This article does not contain an abstract.

Citation

Citation: Croxton TL. Fifty years of the Division of Lung Diseases: a program officer perspective.

Keywords

There are no keywords for this article.

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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—COPD exacerbations and gastroesophageal reflux disease: why proton pump inhibitor therapy is not enough.

Keywords

COPD, chronic obstructive pulmonary disease, exacerbations, gastroesophageal reflux disease, proton pump inhibitor therapy

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Click to read Journal Club-- COPD Exacerbations and Gastroesophageal Reflux Disease: Why Proton Pump Inhibitor Therapy is Not Enough

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