Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomised, Double-blind, 3-way Crossover Study to Compare Pharmacokinetics and Safety of 10 μg BI 1744 CL Plus 5 μg Tiotropium Bromide Given as Fixed Dose Combination Via the Respimat® Inhaler With the Pharmacokinetics and the Safety of the Single Agents, i.e. 10 μg BI 1744 CL and 5 μg Tiotropium Bromide, Delivered Via the Respimat® Inhaler Following 21 Day-treatment Periods in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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.
n/a
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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