Rationale To evaluate efficacy and safety of adding umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA), to inhaled corticosteroid (ICS)/long-acting β-agonist (LABA) in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD) for 12-weeks.
Methods Multicentre, randomised, double-blind, parallel-group study. Inclusion criteria included diagnosis of COPD, modified Medical Research Council Dyspnoea Scale score ≥2 (i.e. patients symptomatic on ICS/LABA), post-salbutamol forced expiratory volume in one second (FEV1) ≤70% predicted and FEV1/forced vital capacity ratio of 1 at Day 85; other endpoints included 0−6 h weighted mean FEV1, rescue medication use, COPD assessment test (CAT) score, and transition dyspnoea index (TDI) score. Adverse events (AEs) were also investigated.
Results In the UMEC+ICS/LABA and PBO+ICS/LABA groups, 119 and 117 patients were randomised, respectively, receiving fluticasone/salmeterol (40%), budesonide/formoterol (43%), and other ICS/LABA, including generics (17%). Compared with PBO+ICS/LABA, UMEC+ICS/LABA resulted in statistically significant improvements in change from baseline trough FEV1 at Day 85 and 0−6 h weighted mean FEV1 at Day 84 (Table 1). UMEC+ICS/LABA resulted in a statistically significant reduction in change from baseline mean puffs/day of rescue salbutamol over Weeks 1–12 versus PBO+ICS/LABA, but not for percentage of rescue-free days. Change from baseline in CAT score at Day 84 was statistically significantly different for UMEC+ICS/LABA versus PBO+ICS/LABA, but TDI score was not significantly different for UMEC+ICS/LABA versus PBO+ICS/LABA; the study was not powered for these endpoints. Incidence of AEs was similar with UMEC+ICS/LABA and PBO+ICS/LABA; n = 45 (38%) and n = 49 (42%), respectively. The most common AEs were nasopharyngitis (13–15%) and headache (3–7%).
Conclusions UMEC+ICS/LABA improved lung function and reduced rescue medication use (mean puffs/day) and CAT score in patients with COPD versus PBO+ICS/LABA. No additional safety concerns were identified with UMEC+ICS/LABA.
Funded by GlaxoSmithKline (NCT02257372).
COI Statement ARS, JR, AC, WAF, CQZ and YSP are employees of GSK and hold stocks/shares in GSK.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.