Pharmacokinetics and Safety of BI 1744 CL Plus Tiotropium Bromide in Chronic Obstructive Pulmonary Disease (COPD)
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.