Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00400153
Status:
COMPLETED
Last Update Posted:
2014-06-13
First Post:
2006-11-15
Brief Title:
Respimat Combivent Trial in Chronic Obstructive Pulmonary Disease COPD
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Safety and Efficacy of Combivent Respimat in Chronic Obstructive Pulmonary Disease COPD
Status:
COMPLETED
Status Verified Date:
2014-06
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 primary objective of this study is to compare the effect of ipratropium bromidesalbutamol inhalation spray combination administered by the Respimat inhaler 20 mcg100 mcg ipratropium bromide inhalation spray administered by the Respimat inhaler 20 mcg and COMBIVENT MDI administered qid on FEV1 at intervals over a treatment period of 12 weeks in patients with COPD Specifically non-inferiority of Combivent Respimat to COMBIVENT MDI in FEV1 AUC from 0 to 6 hours superiority of Combivent Respimat to Atrovent Respimat monotherapy in FEV1 AUC from 0 to 4 hours and non-inferiority of Combivent Respimat to Atrovent Respimat monotherapy in FEV1 AUC from 4 to 6 hours will be analyzed In addition steady state pharmacokinetics over one dosing interval following 4 weeks of therapy will be characterized in a subgroup of patients
Detailed Description:
None
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