Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-01-05 @ 5:33 PM
Study NCT ID:
NCT00240435
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2005-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Comparison of 12-week Treatment of Two Doses (5 Mcg and 10 Mcg) of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) i
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the safety of tiotropium inhalation solution delivered by the Respimat to placebo and ipratropium bromide MDI.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: