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

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: NCT01727141 and NCT01712516.

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

Conflict of interest statement

Sunovion Pharmaceuticals Inc., provided funding for this research. Donald A. Mahler has participated in advisory boards for AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Grifols, Sunovion, Theravance, and Trevi. He is on the speaker’s bureau for AstraZeneca, Boehringer Ingelheim, and Sunovion. Edward M. Kerwin has participated in advisory boards, speaker panels, or received travel reimbursement for AstraZeneca, Amphastar, Boehringer Ingelheim, Mylan, Novartis, Pearl, Sunovion, Teva, and Theravance. He provided consulting services to Cipla and GlaxoSmithKline. Lindsey Murray is employed by Evidera, which provides consulting and other research services to pharmaceutical, device, government and nongovernment organizations. As an Evidera employee, she works with a variety of companies and organizations and is expressly prohibited from receiving any payment or honoraria directly from these organizations for services rendered. Carole Dembek is a full-time employee of Sunovion Pharmaceuticals Inc.

JCOPDF © 2019.

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