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
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
Outcome
Met primary endpoint
registry Placebo vs UMEC/VI 62.5/25 µg QD; p = 0.003; Least squares mean difference 69.4 (95% CI 24.5 to 114.4); Mixed Models Analysis NCT01323660 ↗
registry Placebo vs UMEC/VI 62.5/25 µg QD; p <0.001; Least squares mean difference 0.243 (95% CI 0.202 to 0.284); Mixed Models Analysis NCT01323660 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Umeclidinium | Other / unclassified | 62.5 ug | Inhaled |
| Subject | Umeclidinium | Other / unclassified | 125 ug | Inhaled |
| Subject | Vilanterol | Other / unclassified | 25 ug | Inhaled |