Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in COPD
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT00239447
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Non-inferiority of lung function response to Tiotropium inhalation solution compared to Spiriva HandiHaler
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 131
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Trough FEV1 response determined at the end of each 4-week period of randomised treatment. at the end of each 4-week period
- Secondary Outcome Measures
Name Time Method FEV1 AUC 0-12h and FVC AUC 0-12h response after 4 weeks FEV1 AUC 0-3h and FVC AUC 0-3h response after the first dose, after 4 weeks Number of occasions of rescue therapy used during study course of 28 weeks Individual FEV1and FVC measurements during study course of 28 weeks Tiotropium plasma concentration data and urinary excretion data at the end of each 4-week period Trough forced vital capacity (FVC) response after 4 weeks Peak response (FEV1 and FVC) within 3 hours after first dose, after 4 weeks pre-dose morning and evening peak expiratory flow rate (PEFR) during study course of 28 weeks Median time to onset of therapeutic response after first dose (FEV1) after first dose and after 4 weeks Number of patients with 15% response above baseline for each treatment at each time point after first dose and after 4 weeks up to 28 weeks
Trial Locations
- Locations (9)
Division of Pulmonary and Critical Care Medicine
🇺🇸Little Rock, Arkansas, United States
Boehringer Ingelheim Investigational Site
🇺🇸Tacoma, Washington, United States
San Jose Clinical Research
🇺🇸San Jose, California, United States
National Jewish Medical and Research Center
🇺🇸Denver, Colorado, United States
LSU MC-Sheveport
🇺🇸Shreveport, Louisiana, United States
Minisota Lung Center
🇺🇸Minneapolis, Minnesota, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
Montreal Chest Institute - McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Division of Pulmonary and Critical Care Medicine🇺🇸Little Rock, Arkansas, United States