A Randomized, Double Blind, Placebo Controlled, Incomplete Block, Crossover, Dose Ranging Study to Evaluate the Dose Response of GSK573719 Administered Once or Twice Daily Over 7 Days in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Phase 2 Completed 163 enrolled GlaxoSmithKline

RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this study is to further characterize the dose response of GSK573719 at doses of 15.6 micrograms (mcg) to 125 mcg once daily in patients with chronic obstructive pulmonary disease (COPD). Treatment with doses of GSK573719 dosed twice daily will also be included to further evaluate dosing frequency. Treatment with tiotropium (18 mcg) once daily via the Handihaler will be included as an active control. A placebo treatment will be included in order to evaluate absolute treatment effect of the different doses of GSK573719.

Timeline

Start: 2011-07-01
Primary completion: 2011-10-01
Completion: 2011-10-27

Outcome

Met primary endpoint

registry Placebo vs UMEC 125 µg QD; p <0.001; Mean Difference (Final Values) 0.183 (95% CI 0.127 to 0.239) NCT01372410 ↗

registry Placebo vs UMEC 15.6 µg QD; p <0.001; Mean Difference (Final Values) 0.113 (95% CI 0.058 to 0.168) NCT01372410 ↗

paper UMEC 125 μg QD demonstrated the greatest improvements in measure of lung function compared with doses of 62.5 μg and below. PMID 24393134 ↗

Publications

Church A, Beerahee M, Brooks J, Mehta R, Shah P. Dose response of umeclidinium administered once or twice daily in patients with COPD: a randomised cross-over study. BMC Pulm Med. 2014 Jan 6;14:2. doi: 10.1186/1471-2466-14-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Tiotropium	Other / unclassified	18 ug	Inhaled
Subject	Umeclidinium	Other / unclassified	15.6 ug	Inhaled
Subject	Umeclidinium	Other / unclassified	31.25 ug	Inhaled
Subject	Umeclidinium	Other / unclassified	62.5 ug	Inhaled
Subject	Umeclidinium	Other / unclassified	125 ug	Inhaled