Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 233
Healthy volunteers: no

Brief summary:
The primary objective of this study is to determine the optimum once daily dose of BI 1744 CL and tiotropium in free dose combination (delivered by the Respimat inhaler) after four week treatment in patients with COPD.

Detailed description:

Arms:
arm 1: low dose inhaled olodaterol orally once daily from the Respimat inhaler arm 2: low dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily arm 3: low dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily arm 4: low dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily arm 5: high dose inhaled olodaterol orally once daily from the Respimat inhaler arm 6: high dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily arm 7: high dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily arm 8: high dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily

Interventions: intervention 1: olodaterol (BI 1744) low intervention 2: low tiotropium bromide intervention 3: olodaterol (BI 1744) high intervention 4: medium tiotropium bromide intervention 5: high tiotropium bromide intervention 6: Placebo intervention 7: Respimat
Intervention descriptions: intervention 1: olodaterol (BI 1744) low intervention 2: low tiotropium bromide intervention 3: olodaterol (BI 1744) high intervention 4: medium tiotropium bromide intervention 5: high tiotropium bromide intervention 6: Placebo intervention 7: Respimat inhaler

Protocol document: