Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomised, Double-blind, Double-dummy, Crossover Efficacy and Safety Comparison of 4-week Treatment Periods of Ba 679 BR Respimat® 5 μg and Tiotropium Inhalation Capsule 18 μg in Patients With COPD
The objective of this trial is to compare the efficacy and the safety of Ba 679 BR Respimat 5 ug once daily to tiotropium inhalation capsule 18 ug (Spiriva inhalation capsule) in a crossover study of 4-week treatment periods in patients with COPD.
This is a 16-week, multi-centre, randomised, double-blind, double-dummy, crossover study of
4-week randomised treatment periods to demonstrate the efficacy and safety of 5 ug of Ba 679
BR inhalation solution from Respimat compared to tiotropium inhalation powder capsule (18
ug) via HandiHaler in patients with COPD. The two 4-week randomised treatment periods are
separated by 4-week washout period.
Study Hypothesis:
The primary aim of this trial is to demonstrate non-inferiority of lung function response to
5 ug (2 actuations of 2.5 ug) of Ba679BR Respimat delivered by the Respimat inhaler once
daily compared to tiotropium (18 ug) inhaled as powder capsule from the HandiHaler once
daily at the end of 4-week treatment periods in patients with COPD. The hypothesis test of
non-inferiority will be performed at alpha = 0.025 (one-sided).
Comparison(s):
The primary efficacy endpoint is the trough FEV1 response determined at the end of each
4-week period of randomised treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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