drugset / Trial / NCT01323660

An Exercise Endurance Study to Evaluate the Effects of Treatment of Chronic Obstructive Pulmonary Disease (COPD) Patients With a Dual Bronchodilator: GSK573719/GW642444.Study B

NCT01323660

Phase 3 Completed 307 enrolled GlaxoSmithKline
RandomizedCrossoverDouble-blindTreatment

Summary

This is a phase III multicenter, randomized, double-blind, placebo-controlled, combination and component, two-period, incomplete block design cross-over study using GSK573719/GW642444. The primary objective is to evaluate lung function and exercise endurance time after 12 weeks of once-daily administration of GSK573719/GW642444 Inhalation Powder (125/25mcg and 62.5/25mcg), GSK573719 Inhalation Powder (125mcg and 62.5mcg), GW642444 Inhalation Powder 25 mcg and placebo delivered by a Novel dry powder inhaler (Novel DPI).

Timeline

Start
2011-03-16
Primary completion
2012-07-01
Completion
2012-07-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Umeclidinium Other / unclassified 62.5 ug Inhaled
Subject Umeclidinium Other / unclassified 125 ug Inhaled
Subject Vilanterol Other / unclassified 25 ug Inhaled