Single Dose Comparison of 3 Doses of Olodaterol in Double Fixed Dose Combination With BI54903 vs. 3 Doses of Olodaterol Mono in Free Combination
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Boehringer Ingelheim
- Locations
- 1
- Primary Endpoint
- FEV1 (AUC0-12h) FEV1 = Forced expiratory volume in one second, AUC = area under the curve
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo + BI 54903
patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"
Intervention: Respimat (Device)
Placebo + BI 54903
patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"
Intervention: Olodaterol (Drug)
Placebo + BI 54903
patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"
Intervention: Olodaterol & BI54903 (Drug)
Placebo + BI 54903
patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"
Intervention: BI54903 (Drug)
Olodaterol low dose + BI54903
patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"
Intervention: Respimat (Device)
Olodaterol low dose + BI54903
patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"
Intervention: Olodaterol (Drug)
Olodaterol low dose + BI54903
patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"
Intervention: Olodaterol & BI54903 (Drug)
Olodaterol low dose + BI54903
patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"
Intervention: BI54903 (Drug)
Olodaterol medium dose + BI54903
patient to receive 2 puffs of each device
Intervention: Respimat (Device)
Olodaterol medium dose + BI54903
patient to receive 2 puffs of each device
Intervention: Olodaterol (Drug)
Olodaterol medium dose + BI54903
patient to receive 2 puffs of each device
Intervention: Olodaterol & BI54903 (Drug)
Olodaterol medium dose + BI54903
patient to receive 2 puffs of each device
Intervention: BI54903 (Drug)
Olodaterol high dose + BI54903
patient to receive 2 puffs of each device
Intervention: Respimat (Device)
Olodaterol high dose + BI54903
patient to receive 2 puffs of each device
Intervention: Olodaterol (Drug)
Olodaterol high dose + BI54903
patient to receive 2 puffs of each device
Intervention: Olodaterol & BI54903 (Drug)
Olodaterol high dose + BI54903
patient to receive 2 puffs of each device
Intervention: BI54903 (Drug)
Olodaterol l dose + BI54903
patient to receive 2 puffs of each device
Intervention: Respimat (Device)
Olodaterol l dose + BI54903
patient to receive 2 puffs of each device
Intervention: Olodaterol (Drug)
Olodaterol l dose + BI54903
patient to receive 2 puffs of each device
Intervention: Olodaterol & BI54903 (Drug)
Olodaterol l dose + BI54903
patient to receive 2 puffs of each device
Intervention: BI54903 (Drug)
Olodaterol m dose + BI54903
patient to receive 2 puffs of each device
Intervention: Respimat (Device)
Olodaterol m dose + BI54903
patient to receive 2 puffs of each device
Intervention: Olodaterol (Drug)
Olodaterol m dose + BI54903
patient to receive 2 puffs of each device
Intervention: Olodaterol & BI54903 (Drug)
Olodaterol m dose + BI54903
patient to receive 2 puffs of each device
Intervention: BI54903 (Drug)
Olodaterol h dose + BI54903
patient to receive 2 puffs of each device
Intervention: Respimat (Device)
Olodaterol h dose + BI54903
patient to receive 2 puffs of each device
Intervention: Olodaterol (Drug)
Olodaterol h dose + BI54903
patient to receive 2 puffs of each device
Intervention: Olodaterol & BI54903 (Drug)
Olodaterol h dose + BI54903
patient to receive 2 puffs of each device
Intervention: BI54903 (Drug)
Outcomes
Primary Outcomes
FEV1 (AUC0-12h) FEV1 = Forced expiratory volume in one second, AUC = area under the curve
Time Frame: 12 hours
Secondary Outcomes
- FEV1 (AUC0-24h)(24 hours)
- FEV1 (AUC12-24h)(12 hours)
- Peak FEV1(12 hours)