12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT00240435
- Lead Sponsor
- Boehringer Ingelheim
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 491
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Trough FEV1 response after 12 weeks of treatment. after 12 weeks
- Secondary Outcome Measures
Name Time Method Trough FEV1 response after 1, 4 and 8 weeks Trough FVC response after 1, 4, 8 and 12 weeks Therapeutic response and percentage of responders after 0 and 12 weeks Weekly mean pre-dose morning and evening PEFR during study course of 12 weeks Number of occasions of rescue therapy used per day (PRN salbutamol) during study course of 12 weeks Physician's Global Evaluation during 15 weeks time to first exacerbation 15 weeks number of exacerbations 15 weeks number of exacerbation days 15 weeks Patient satisfaction and preference 12 weeks FEV1 and FVC area under the curve and peak response after 0, 1, 4, 8 and 12 weeks Individual FEV1 and FVC measurements at each time point during study course of 12 weeks Number of patients with at least one exacerbation of COPD 15 weeks COPD symptom scores during 15 weeks All adverse events during 15 weeks, follow-up period included Pulse rate and blood pressure for the first three hours following dosing after 0, 1, 4, 8 and 12 weeks Routine blood chemistry, haematology and urinalysis after 12 weeks 12-lead ECG after 12 weeks Physical examination after 12 weeks
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Trial Locations
- Locations (11)
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
University of California - Los Angeles
🇺🇸Los Angeles, California, United States
Boehringer Ingelheim Investigational Site
🇨🇦Toronto, Ontario, Canada
Hopital Laval
🇨🇦Ste-Foy, Quebec, Canada
St. Joseph's Hospital Cardiac Research
🇨🇦Hamilton, Ontario, Canada
Rocky Mountain Center for Clinical Research
🇺🇸Wheat Ridge, Colorado, United States
Department of Respiratory Medicine
🇨🇦Toronto, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Centre de Recherche Clinique -CUSE
🇨🇦Sherbrooke, Quebec, Canada
SMBD--Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
c/o Hemodynamics Offices
🇨🇦Saskatoon, Saskatchewan, Canada