ALBUTEROL AEROSOL VERSUS ALBUTEROL ROTACAPS(R) IN EXERCISE-INDUCED BRONCHOSPASM IN CHILDREN

The purpose of this study was to determine the safety and effectiveness of albuterol aerosol 180 mu g and albuterol powder 200 mu g in the prevention of exercise-induced bronchospasm in children. Forty-six patients aged 4-11 years with asthma and exercise-induced bronchospasm were enrolled in this randomized, double-blind, single-dose, three-way crossover study comparing albuterol aerosol, albuterol powder, and placebo. Exercise challenge was performed at the screening visit for qualifying and baseline determinations of pulmonary function and then 15 min after drug administration at each of three visits. Prevention of exercise-induced bronchospasm was assessed by comparing across all treatment groups the percentage change in FEV(1) from pre- to postexercise, the percentage of patients protected by treatment, postexercise minimum FEV(1), and postexercise change in FEV(1). Safety was assessed by observation of clinical adverse events, laboratory tests, physical examination, electrocardiogram and rhythm strips, vital signs, and pulmonary auscultation.