A Single-Dose Efficacy Comparison of Albuterol Hydrofluoroalkane (HFA) Breath-operated Inhaler (BOI) (Volare Easi-Breathe™) and Albuterol HFA Meter Dose Inhaler (MDI) (Volare™) in Adolescents and Adults With Exercise-Induced Bronchospasm

albuterol aerosol by HFA MDI

albuterol aerosol by HFA BOI

placebo aerosol by HFA

The primary endpoint was mean maximum % change in the baseline absolute forced expiratory volume in 1 second (FEV1) value observed up to 1 hour post-challenge.

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

Mean percent change in the baseline absolute FEV1 value at each post-challenge time point

Mean absolute change in the baseline absolute FEV1 value at each post-challenge time point

Mean percent change in the baseline percent-predicted FEV1 value at each post-challenge time point

Mean largest negative (or mean smallest positive) percent change in the baseline absolute FEV1 value observed up to one hour post-challenge

Mean largest negative (or mean smallest positive) percent change in the average test-day pre-dose baseline percent predicted 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

Total changes in FEV1 expressed as the baseline-adjusted area-under-the-effect curve of the percent-predicted FEV1 versus time over 60 minutes (AUEC0 60)

Percentage of patients who are "protected" (maximum percent decrease in the baseline absolute FEV1 <10%), "partially protected" (10 20%), and "unprotected" (>20%).