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...
Date First Received: October 14, 2005
Last Updated: November 26, 2008
Verified by: Boehringer Ingelheim Pharmaceuticals, November 2008
Clinical Trial Phase: Phase 3 | Start Date: November 2002
Overall Status: Completed
Estimated Enrollment: 336
Brief Summary
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”
Condition Keyword(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Intervention(s) in this Clinical Trial
- Device: 5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler
- Device: 10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler
Outcome Measures for this Clinical Trial
Primary Measures
- FEV1 (trough, AUC 0-6h; peak, onset and duration of response; percent responders), FVC (trough, AUC 0-6h, peak), twice daily PEFR, rescue medication use, COPD symptoms, global evaluations
Secondary Measures
- Adverse events, vital signs, laboratory evaluations, ECG testing and physical examinations
Criteria for Participation in this Clinical Trial
- Outpatients of either sex, aged >/= 40 years with a diagnosis of COPD (FEV1 </= 60% predicted [ECCS criteria] and FEV1/FVC </= 70%)
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 40 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Boehringer Ingelheim Pharmaceuticals
Overall Clinical Trial Officials and Contacts
Boehringer Ingelheim Study Coordinator Study Chair Boehringer Ingelheim Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on December 03, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00239473
Study ID Number: 205.251
ClinicalTrials.gov Identifier: NCT00239473
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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