Efficacy and Safety of Once-Daily Inhaled Umeclidinium in Asian Patients with COPD: Results from a Randomized, Placebo-Controlled Study

Nanshan Zhong, Jinping Zheng, Sang Haak Lee, David A Lipson, Xin Du, Shunquan Wu, Nanshan Zhong, Jinping Zheng, Sang Haak Lee, David A Lipson, Xin Du, Shunquan Wu

Abstract

Purpose: Previous studies demonstrating efficacy and safety of once-daily umeclidinium (UMEC) in patients with chronic obstructive pulmonary disease (COPD) have included few Asian patients. This study evaluated efficacy and safety of UMEC 62.5 mcg versus placebo in Asian patients with COPD.

Patients and methods: A Phase III, randomized, double-blind, parallel-group study. Patients (aged ≥40 years with COPD, pre-, and post-albuterol forced expiratory volume in 1 s [FEV1]/forced vital capacity ratio <0.70 and low risk of exacerbations) were randomized 2:1 to once-daily UMEC 62.5 mcg or placebo via the ELLIPTA inhaler for 24 weeks. Primary endpoint was change from baseline (CFB) in trough FEV1 on Day 169. Secondary endpoints were weighted mean FEV1 over 0-6 hrs post-dose on Day 1 and CFB in Transition Dyspnea Index (TDI) focal score on Day 168.

Results: A total of 306 patients were included in the modified intent-to-treat population (UMEC: 205; placebo: 101). UMEC versus placebo provided a statistically significant improvement in least squares (LS) mean trough FEV1 between baseline and Day 169 (154 mL [95% confidence interval (CI): 113, 194]; p<0.001). A clinically meaningful difference of 125 mL in favor of UMEC (95% CI: 103, 147; p<0.001) was also seen in LS weighted mean FEV1 0-6 hrs post-dose on Day 1. A LS mean treatment difference in TDI focal score of 0.9 units in favor of UMEC was seen on Day 168 (95% CI: 0.3, 1.5; p=0.004). Incidence of on-treatment adverse events (AEs) was lower in the placebo (55%) versus UMEC arm (60%); non-fatal serious AEs, drug-related AEs, and AEs leading to withdrawal were similar with UMEC and placebo.

Conclusion: Once-daily UMEC 62.5 mcg resulted in statistically significant and clinically meaningful improvements in lung function and dyspnea, compared with placebo, in Asian patients with COPD, with no new safety concerns observed.

Keywords: Asia; Transition Dyspnea Index; chronic obstructive pulmonary disease; forced expiratory volume in 1 second; umeclidinium.

Conflict of interest statement

JZ has participated in advisory boards and speaker’s bureaus for AstraZeneca and Boehringer Ingelheim and has conducted a study supported by GSK. DAL and XD are employees of GSK and hold stocks and shares in the company. SW is an employee of GSK. The authors report no other conflicts of interest in this work.

© 2020 Zhong et al.

Figures

Figure 1
Figure 1
Patient disposition. Abbreviations: mITT, modified intent-to-treat; UMEC, umeclidinium.
Figure 2
Figure 2
Change from baseline in (A) trough FEV1 and (B) trough FVC. Abbreviations: CI, confidence interval; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; LS, least squares; UMEC, umeclidinium.
Figure 3
Figure 3
TDI focal score at Days 28, 84, and 168. Abbreviations: CI, confidence interval; LS, least squares; TDI, Transient Dyspnea Index; UMEC, umeclidinium.

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