Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 108
Healthy volunteers: no

Brief summary:
The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.

Detailed description:

Arms:
arm 1: olodaterol placebo and/or Tiotropium placebo inhaled once daily arm 2: Low dose inhaled orally once daily from Respimat inhaler arm 3: High dose inhaled orally once daily from Respimat inhaler arm 4: 18mcg inhaled once daily from Handihaler

Interventions: intervention 1: Olodaterol (BI1744) Low intervention 2: Placebo (for olodaterol BI1744) intervention 3: Placebo (for Tiotropium) intervention 4: Olodaterol (BI1744) High intervention 5: Tiotropium 18 mcg
Intervention descriptions: intervention 1: Low dose inhaled orally once daily from Respimat inhaler intervention 2: Placebo (olodaterol low and high dose)delivered by Respimat intervention 3: Placebo (Tiotropium 18 mcg) delivered by HandiHaler intervention 4: High dose inhaled orally once daily from Respimat inhaler intervention 5: 18mcg inhaled once daily from Handihaler

Protocol document: