Fluticasone propionate/salmeterol and exercise-induced asthma in children with persistent asthma.

Rationale: Exercise is a common trigger in children with persistent asthma and inhaled corticosteroids have been shown to effectively treat clinical manifestations of persistent asthma, including protection from decrements in lung function caused by exercise. The goal of this study was to evaluate the effectiveness of fluticasone propionate/salmeterol 100/50 mcg compared with fluticasone propionate 100 mcg for the prevention of airflow limitation triggered by standardized exercise challenge in pediatric and adolescent patients with persistent asthma.

Methods: Multicenter, randomized, double-blind, parallel group trial of 248 subjects with persistent asthma (age 4-17 years) randomized to receive fluticasone propionate/salmeterol (100/50 mcg twice daily) or fluticasone propionate alone (100 mcg twice daily) via Diskus for 4 weeks. Exercise challenge tests were performed during screening and approximately 8 hr after administration of the blinded study medication on Treatment Day 28.

Results: After 4 weeks of therapy both treatments provided protection following exercise challenge. The protection estimated by the maximal fall in FEV(1) was significantly better for fluticasone propionate/salmeterol (9.5 +/- 0.8% [mean +/- SE]) compared with fluticasone propionate alone (12.7 +/- 1.1%, P = 0.021). Statistically significant differences were not observed for asthma rescue-free days and asthma symptom-free days.

Conclusion: Chronic dosing with fluticasone propionate/salmeterol in a single device provides superior protection compared with an inhaled corticosteroid alone in protecting against exercise-induced asthma in children with persistent asthma.