Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 328
Healthy volunteers: no

Brief summary:
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat inhaler once daily for 4 weeks in Japanese patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations.

Detailed description:

Arms:
arm 1: 2 puffs of 2.5 Âµg/actuation arm 2: 2 puffs of 5 Âµg/actuation arm 3: 2 puffs arm 4: 2 puffs of 1 Âµg/actuation

Interventions: intervention 1: BI 1744 CL 2 Âµg intervention 2: BI 1744 CL 5 Âµg intervention 3: BI 1744 CL 10 Âµg intervention 4: Placebo
Intervention descriptions: intervention 1: 2 puffs of 1 Âµg/actuation delivered by the RespimatÂ® inhaler intervention 2: 2 puffs of 2.5 Âµg/actuation delivered by the RespimatÂ® inhaler intervention 3: 2 puffs of 5 Âµg/actuation delivered by RespimatÂ® intervention 4: 2 puffs delivered by the RespimatÂ® inhaler

Protocol document: