Evaluate the Efficacy and Safety of GSK573719 Delivered Via a Novel Dry Powder Inhaler in Subjects With COPD

Phase 3 Completed 206 enrolled GlaxoSmithKline

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to assess if 12 weeks' treatment with GSK573719 Inhalation Powder is safe and effective compared with placebo or no active drug intake, when administered once-daily in subjects with Chronic Obstructive Pulmonary Disease (COPD).

Timeline

Start: 2011-07-01
Primary completion: 2012-02-01
Completion: 2012-02-13

Outcome

Met primary endpoint

registry Placebo vs UMEC 62.5 µg; p <0.001; Least squares mean difference 0.127 (95% CI 0.052 to 0.202) NCT01387230 ↗

registry Placebo vs UMEC 125 µg; p <0.001; Least squares mean difference 0.152 (95% CI 0.076 to 0.229) NCT01387230 ↗

Publications

Trivedi R, Richard N, Mehta R, Church A. Umeclidinium in patients with COPD: a randomised, placebo-controlled study. Eur Respir J. 2014 Jan;43(1):72-81. doi: 10.1183/09031936.00033213. Epub 2013 Aug 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Umeclidinium	Other / unclassified	62.5 ug	Inhaled
Subject	Umeclidinium	Other / unclassified	125 ug	Inhaled