Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 47
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the systemic exposure to BI 1744 BS and tiotropium at steady state following inhalation of the fixed dose combination (FDC) of 10 μg BI 1744 CL plus 5 μg tiotropium bromide with the systemic exposure to BI 1744 BS and tiotropium at steady state following inhalation of the single agents, i.e., 10 μg BI 1744 CL and 5 μg tiotropium bromide, when administered once-daily via the Respimat® Inhaler for 21 days.

The secondary objectives were to compare the safety and tolerability (adverse events, 12-lead electrocardiogram recordings, pulmonary function testing) of BI 1744 CL and tiotropium bromide when administered as fixed dose combination or as single-agent therapy.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: BI 1744 CL intervention 2: BI 1744 CL/Tiotropium FDC intervention 3: Tiotropium
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: