Comparison of Tiotropium and Ipratropium in a Double-Blind, Double-dummy, Efficacy and Safety Study in Adults With COPD
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT00274040
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Comparison of 18 mcg of Tiotropium Inhalation Capsules and ipratropiumMetered Dose Inhaler (2 puffs of 20 mcg, four times daily) in a Double-Blind, Double-dummy, Efficacy and Safety Study in Adults with Chronic Obstructive Pulmonary Disease (COPD).
The objective of this study is to compare the bronchodilator efficacy and safety of tiotropium inhalation capsules (18 mcg once daily) and ipratropium MDI (2 puffs of 20 mcg q.i.d.) in patients with chronic obstructive pulmonary disease (COPD).
- Detailed Description
This is a 2-treatment, randomized, double-blind, parallel design trial in adult patient with COPD.
Each dose of tiotropium or placebo will consist of one capsule self administered from the HandiHaler device once daily during the treatment period (tiotropium or placebo). Each dose will be taken at the same time each morning between 08:00 a.m. and 10:00 a.m.
Each dose of ipratropium MDI or placebo MDI will consist of 2 puffs; patients will inhale 2 puffs four times daily. The first dose will be taken at the same time each morning between 08:00 a.m. and 10:00 a.m.; subsequent doses will be taken at lunch, at dinner and when going to bed.
Study Hypothesis:
The null hypothesis is that there is no difference in mean response between tiotropium and ipratropium.
The alternative hypothesis is that there is a difference in mean response between tiotropium and ipratropium.
Comparison(s):
This is a multi-center, randomized, double-blind, double-dummy, parallel group trial to compare the bronchodilator efficacy and safety of Tiotropium (18 mcg once a day) and ipratropium Metered Dose Inhaler (2 puffs of 18 mcg four times a day).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 141
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Trough FEV1 response: change from baseline FEV1 (visit 2) to visit 4 trough FEV1 4 weeks
- Secondary Outcome Measures
Name Time Method Trough FVC response 4 weeks Number of patients with abnormalities in routine blood chemistry, haematology and urinanalysis 4 weeks All adverse events 4 weeks FEV1 (AUC0-3) response (change from baseline) for the 3 hours post drug administration 4 weeks FVC (AUC0-3) response (as defined for FEV1) 4 weeks Patient questionnaire 4 weeks Daily PEFR 4 weeks Vital signs (pulse rate and blood pressure) 4 weeks Amount of rescue medication 4 weeks Changes from baseline in 12-lead electrocardiogram (ECG) 4 weeks Physical examination 4 weeks
Trial Locations
- Locations (18)
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Jeonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
Jeonnam National University Hospital
🇰🇷Kwangju, Korea, Republic of
Pusan University Hospital
🇰🇷Pusan, Korea, Republic of
Chung-ang University Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Hosital
🇰🇷Seoul, Korea, Republic of
Kangnam St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Hospital
🇰🇷Seoul, Korea, Republic of
Kyoungbuk National University Hospital
🇰🇷Seoul, Korea, Republic of
Kyunghee University Hospital
🇰🇷Seoul, Korea, Republic of
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