Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Dose ranging Chronic Bronchitis Long-acting muscarinic antagonist cross-over COPD Emphysema Chronic Obstructive Pulmonary Disease (COPD) anticholinergic
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 176
Healthy volunteers: no

Brief summary:
The study will evaluate the dose response, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD.

Detailed description:
This is multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-way cross-over, incomplete block design study to evaluation of 5 doses of GSK573719 administered once-daily and 3 doses of GSK573719 administered twice-daily over 14 days in subjects with COPD and will include tiotropium as an open-label active control. The pharmacokinetic profile of GSK573719 will also be evaluated.

Arms:
arm 1: Placebo arm 2: Tiotropium arm 3: GSK573719 1000mcg once daily arm 4: GSK573719 500mcg once daily arm 5: GSK573719 250mcg once daily arm 6: GSK573719 125mcg once daily arm 7: GSK573719 62.5 mcg once daily arm 8: GSK573719 250mcg twice daily arm 9: GSK573719 125mcg twice daily arm 10: GSK573719 62.5mcg twice daily

Interventions: intervention 1: Tiotropium intervention 2: Placebo intervention 3: GSK573179
Intervention descriptions: intervention 1: long-acting muscarinic receptor antagonist; 18mcg once-daily intervention 2: Inactive/ excipients only intervention 3: GSK573179 investigational drug

Protocol document: