28-day Repeat Dose Study of GSK573719

Phase 2 Completed 285 enrolled GlaxoSmithKline

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study will evaluate the efficacy, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD

Timeline

Start: 2009-12-15
Primary completion: 2010-07-04
Completion: 2010-07-04

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs UMEC 125 µg; p <0.001; Mean Difference (Final Values) 0.159 (95% CI 0.088 to 0.229) NCT01030965 ↗

registry analysis (superiority or other test); Placebo vs UMEC 250 µg; p <0.001; Median Difference (Final Values) 0.168 (95% CI 0.099 to 0.238) NCT01030965 ↗

registry analysis (superiority or other test); Placebo vs UMEC 500 µg; p <0.001; Mean Difference (Final Values) 0.150 (95% CI 0.080 to 0.220) NCT01030965 ↗

Publications

Background Decramer M, Maltais F, Feldman G, Brooks J, Harris S, Mehta R, Crater G. Bronchodilation of umeclidinium, a new long-acting muscarinic antagonist, in COPD patients. Respir Physiol Neurobiol. 2013 Jan 15;185(2):393-9. doi: 10.1016/j.resp.2012.08.022. Epub 2012 Sep 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Umeclidinium	Other / unclassified	125 ug	Inhaled
Subject	Umeclidinium	Other / unclassified	250 ug	Inhaled
Subject	Umeclidinium	Other / unclassified	500 ug	Inhaled