292448
Last Update Posted: 2013-10-29
Recruiting has ended
All Genders accepted | 40 Years + |
157 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
A Randomised, Double-blind, Crossover Study of Ba679BR Respimat in Patients With Chronic Obstructive Pulmonary Disease (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.
Eligibility
Relevant conditions:
Pulmonary Disease, Chronic Obstructive
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov