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Dose Response of Levalbuterol vs Albuterol in Pediatric Asthma
NCT00685347Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2003
- Primary completion
- Jun 2003
- Countries
- 1
- Sponsor
- Sumitomo Pharma America
- Modality
- Small Molecules
- Drugs
- levalbuterol
- Conditions
- asthmaExercise-induced bronchoconstriction (EIB)
01
Overview
Phase 2, randomised, double-blind trial of levalbuterol in asthma and Exercise-induced bronchoconstriction (EIB) (2 arms), sponsored by Sumitomo Pharma America. Primary endpoint: Maximum percent decrease in FEV1 from visit post-dose/pre-challenge FEV1. Started Jan 2003; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Levalbuterol Arm
Subjects receive Levalbuterol HFA MDI at 45, 90, and 180 mcg in a randomized sequence.
Racemic Albuterol Arm
Subjects receive Racemic Albuterol HFA MDI at 90, 180, and 360 mcg in a randomized sequence.
03
Who it enrols
Pediatric subjects (6-11 years) with a documented diagnosis of asthma for at least 6 months and exercise-induced bronchoconstriction. Subjects must be in good health aside from asthma.
04
Endpoints
Primary
Maximum percent decrease in FEV1 from visit post-dose/pre-challenge FEV1
Secondary
Area under the percent decrease from visit post-dose/pre-challenge FEV1 curve
Time to recovery (min)
Protected/Unprotected Subjects Counts
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