Montelukast added to budesonide in children with persistent asthma: A randomized, double-blind, crossover study

Abstract

Objective: We tested the hypothesis that adding montelukast to budesonide would improve asthma control in children with inhaled glucocorticoid-dependent persistent asthma. Study design: In a multicenter, randomized, double-blind, crossover study, we compared the benefit of adding montelukast, 5 mg, or placebo once daily to budesonide, 200 μg, twice daily. Results: After a 1-month run-in with budesonide, 200 μg, twice daily, 279 children were randomized to montelukast or placebo. The mean ± SD age was 10.4 ± 2.2 years, the mean forced expiratory volume in 1 second (FEV1) was 77.7% ± 10.6% predicted, and reversibility was 18.1% ± 12.9%. Compared with adding placebo to budesonide, adding montelukast produced significant improvements in mean percent change from baseline FEV1 (P = .062 [P = .010 for per-protocol analysis]), mean absolute change from baseline FEV1 (P = .040), mean increase from baseline in morning (P = .023) and evening (P = .012) peak expiratory flows, decrease in exacerbation days by approximately 23% (P < .001), decreased β2-agonist use (P = .013), and reduced blood eosinophil counts (P < .001). The treatments did not differ significantly with regard to safety. Conclusions: Montelukast, 5 mg, added to budesonide improved asthma control significantly, indicated by a small additive effect on lung function and a clinically relevant decrease in asthma exacerbation days.