Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292448
Status:
COMPLETED
Last Update Posted:
2013-10-29
First Post:
2006-02-15
Brief Title:
A Randomised Double-blind Crossover Study of Ba679BR Respimat in Patients With Chronic Obstructive Pulmonary Disease COPD
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 25 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 0025 one-sided
Comparisons
The primary efficacy endpoint is the trough FEV1 response determined at the end of each 4-week period of randomised treatment
Study Hypothesis
The primary aim of this trial is to demonstrate non-inferiority of lung function response to 5 ug 2 actuations of 25 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 0025 one-sided
Comparisons
The primary efficacy endpoint is the trough FEV1 response determined at the end of each 4-week period of randomised treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None