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Comparison of Albuterol HFA BOI and MDI in Exercise-Induced Bronchospasm
NCT00085774Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2004
- Primary completion
- Sep 2004
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- albuterol spiromax
- Conditions
- exercise-induced bronchospasm (EIB)
01
Overview
Phase 3, randomised, double-blind trial of albuterol spiromax in exercise-induced bronchospasm (EIB) (3 arms), sponsored by Teva Pharmaceutical Industries Ltd. Primary endpoint: Mean maximum % change in the baseline absolute forced expiratory volume in 1 second (FEV1) value observed up to 1 hour post-challenge. Started Jun 2004; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Albuterol HFA BOI
Albuterol HFA Breath-operated Inhaler 160 mcg
Albuterol HFA MDI
Albuterol HFA Meter Dose Inhaler 160 mcg
Placebo
Placebo HFA
03
Who it enrols
Adolescents and adults (12-40 years) with exercise-induced bronchospasm (EIB), with or without asthma, demonstrated by >=15% decrease in FEV1 post-exercise. Must have predicted FEV1 >=70% and be non-smokers.
04
Endpoints
Primary
Mean maximum % change in the baseline absolute forced expiratory volume in 1 second (FEV1) value observed up to 1 hour post-challenge
Secondary
Mean maximum percent change in the baseline percent predicted FEV1 value observed up to one hour post-challenge
Mean maximum absolute change in the baseline absolute FEV1 value observed up to one hour post-challenge
Time to recovery (in minutes) measured from time of completion of exercise challenge to time FEV1 returns to 10% or less of baseline value during the recovery phase
Percentage of patients who are "protected" (maximum percent decrease in the baseline absolute FEV1 <10%), "partially protected" (10-20%), and "unprotected" (>20%)
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