Montelukast Added to Budesonide in Children With Persistent Asthma: A Randomized, Double-Blind, Crossover Study

J Pediatr. 2001 May;138(5):694-8. doi: 10.1067/mpd.2001.112899.

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 microg, twice daily.

Results: After a 1-month run-in with budesonide, 200 microg, 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 (FEV(1)) 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 FEV(1) (P =.062 [P =.010 for per-protocol analysis]), mean absolute change from baseline FEV(1) (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 beta2-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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Acetates / administration & dosage
  • Acetates / adverse effects
  • Acetates / therapeutic use*
  • Anti-Asthmatic Agents / administration & dosage
  • Anti-Asthmatic Agents / adverse effects
  • Anti-Asthmatic Agents / therapeutic use*
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Budesonide / administration & dosage
  • Budesonide / adverse effects
  • Budesonide / therapeutic use
  • Double-Blind Method
  • Drug Therapy, Combination
  • Forced Expiratory Volume / physiology
  • Humans
  • Predictive Value of Tests
  • Quality of Life
  • Quinolines / administration & dosage
  • Quinolines / adverse effects
  • Quinolines / therapeutic use*
  • Treatment Outcome

Substances

  • Acetates
  • Anti-Asthmatic Agents
  • Quinolines
  • Budesonide
  • montelukast