At a glance
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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
In Brief
A Phase 3 clinical trial evaluating GSK573719/GW642444 125/25, GSK573719/GW642444 62.5/25, and 4 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 307 participants across 53 sites in 7 countries.
Detailed 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).
Study Details
Timeline
Interventions
125mcg/ 25mcg QID (Once daily , inhaled)
62.5mcg/25mcg QID
125mcg QID
62.5mcg QID
25mcg QID
Comparator QID