Olodaterol Bridging Study in Asthma
Phase 2
Withdrawn
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT01428622
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The aim of the study is to establish the olodaterol dose in the ethanolic fixed dose combination (FDC) with BI 54903 which is equivalent in bronchodilator effect and systemic exposure to the 5 µg olodaterol reference dose in the aqueous inhalation solution (AIS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo + BI 54903 Respimat patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B" Placebo + BI 54903 Olodaterol & BI54903 patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B" Olodaterol low dose + BI54903 Respimat patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B" Olodaterol low dose + BI54903 Olodaterol & BI54903 patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B" Olodaterol medium dose + BI54903 Respimat patient to receive 2 puffs of each device Olodaterol medium dose + BI54903 Olodaterol & BI54903 patient to receive 2 puffs of each device Olodaterol high dose + BI54903 Respimat patient to receive 2 puffs of each device Olodaterol high dose + BI54903 Olodaterol & BI54903 patient to receive 2 puffs of each device Olodaterol high dose + BI54903 BI54903 patient to receive 2 puffs of each device Olodaterol l dose + BI54903 Respimat patient to receive 2 puffs of each device Olodaterol l dose + BI54903 Olodaterol patient to receive 2 puffs of each device Olodaterol l dose + BI54903 Olodaterol & BI54903 patient to receive 2 puffs of each device Olodaterol l dose + BI54903 BI54903 patient to receive 2 puffs of each device Olodaterol m dose + BI54903 Respimat patient to receive 2 puffs of each device Olodaterol m dose + BI54903 Olodaterol & BI54903 patient to receive 2 puffs of each device Olodaterol m dose + BI54903 BI54903 patient to receive 2 puffs of each device Olodaterol h dose + BI54903 Respimat patient to receive 2 puffs of each device Olodaterol h dose + BI54903 Olodaterol & BI54903 patient to receive 2 puffs of each device Olodaterol h dose + BI54903 BI54903 patient to receive 2 puffs of each device Olodaterol medium dose + BI54903 BI54903 patient to receive 2 puffs of each device Placebo + BI 54903 BI54903 patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B" Olodaterol low dose + BI54903 BI54903 patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B" Placebo + BI 54903 Olodaterol patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B" Olodaterol low dose + BI54903 Olodaterol patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B" Olodaterol medium dose + BI54903 Olodaterol patient to receive 2 puffs of each device Olodaterol high dose + BI54903 Olodaterol patient to receive 2 puffs of each device Olodaterol m dose + BI54903 Olodaterol patient to receive 2 puffs of each device Olodaterol h dose + BI54903 Olodaterol patient to receive 2 puffs of each device
- Primary Outcome Measures
Name Time Method FEV1 (AUC0-12h) FEV1 = Forced expiratory volume in one second, AUC = area under the curve 12 hours
- Secondary Outcome Measures
Name Time Method FEV1 (AUC0-24h) 24 hours FEV1 (AUC12-24h) 12 hours Peak FEV1 12 hours
Trial Locations
- Locations (1)
1249.7.33003 Boehringer Ingelheim Investigational Site
🇫🇷Gières, France