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

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 microg, twice daily.

Results: After a 1-month run-in with budesonide, 200 microg, twice daily, 279 children were randomized to montelukast or placebo.