Bronchodilation of umeclidinium, a new long-acting muscarinic antagonist, in COPD patients

Abstract

BackgroundThis study evaluated the dose–response of the new long-acting muscarinic antagonist umeclidinium (GSK573719) in patients with COPD. MethodsThis randomized, double-blind, placebo-controlled, parallel-group study evaluated three once-daily doses of umeclidinium (125, 250 and 500μg) for 28days in 285 patients with COPD having FEV1 of 35–70% predicted (mean (SD) age=61.4 (8.41); mean (SD) post-bronchodilator FEV1=1.577 (0.450)). The primary endpoint was morning trough FEV1 at Day 29. Secondary endpoints included 0–6h weighted mean FEV1 and serial FEV1 measured over 6h post-dose and at trough. Safety and pharmacokinetics were also assessed. ResultsAll doses of umeclidinium significantly increased trough FEV1 over placebo from 150 to 168mL (p<0.001), 0–6h weighted mean FEV1 from 113 to 211mL (p<0.001), and serial FEV1 at each point in time over 24h. Reductions in salbutamol use and improvements in FVC were noted for all doses. Umeclidinium was well tolerated with no apparent treatment-related changes in vital signs. ConclusionOnce-daily umeclidinium provides clinically significant, sustained improvement in lung function and is well tolerated.