Olodaterol Bridging Study in Asthma
NCT01428622 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2011-11-22
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).
Conditions
Interventions
- DEVICE
-
Respimat
aqueous and ethanolic solution
- DEVICE
-
Respimat
aqueous and ethanolic solution
- DEVICE
-
Respimat
aqueous and ethanolic solution
- DEVICE
-
Respimat
aqueous and ethanolic solution
- DEVICE
-
Respimat
aqueous and ethanolic solution
- DEVICE
-
Respimat
aqueous and ethanolic solution
- DEVICE
-
Respimat
aqueous and ethanolic solution
- DRUG
-
Olodaterol
aqueous solution
- DRUG
-
Olodaterol
aqueous solution
- DRUG
-
Olodaterol
aqueous solution
- DRUG
-
Olodaterol
aqueous solution
- DRUG
-
Olodaterol
aqueous solution
- DRUG
-
Olodaterol
aqueous solution
- DRUG
-
Olodaterol
aqueous solution
- DRUG
-
Olodaterol & BI54903
ethanolic solution
- DRUG
-
Olodaterol & BI54903
ethanolic solution
- DRUG
-
Olodaterol & BI54903
ethanolic solution
- DRUG
-
Olodaterol & BI54903
ethanolic solution
- DRUG
-
Olodaterol & BI54903
ethanolic solution
- DRUG
-
Olodaterol & BI54903
ethanolic solution
- DRUG
-
Olodaterol & BI54903
ethanolic solution
- DRUG
-
BI54903
ethanolic solution
- DRUG
-
BI54903
ethanolic solution
- DRUG
-
BI54903
ethanolic solution
- DRUG
-
BI54903
ethanolic solution
- DRUG
-
BI54903
ethanolic solution
- DRUG
-
BI54903
ethanolic solution
- DRUG
-
BI54903
ethanolic solution
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-10-31
Countries
- France
Study Locations
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