title: 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.
  
  
  METHODS
  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.
authors.affiliation: Department of Pediatrics & Child Health, University of Manitoba, Winnipeg, Manitoba, Canada.
authors.forename: F E
authors.initials: FE
authors.lastname: Simons
authors.forename: J R
authors.initials: JR
authors.lastname: Villa
authors.forename: B W
authors.initials: BW
authors.lastname: Lee
authors.forename: A M
authors.initials: AM
authors.lastname: Teper
authors.forename: B
authors.initials: B
authors.lastname: Lyttle
authors.forename: G
authors.initials: G
authors.lastname: Aristizabal
authors.forename: W
authors.initials: W
authors.lastname: Laessig
authors.forename: A
authors.initials: A
authors.lastname: Schuster
authors.forename: J
authors.initials: J
authors.lastname: Perez-Frias
authors.forename: B E
authors.initials: BE
authors.lastname: Sekerel
authors.forename: J
authors.initials: J
authors.lastname: Menten
authors.forename: J A
authors.initials: JA
authors.lastname: Leff
mesh_terms: D000085:Acetates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D019819:Budesonide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D003521:Cyclopropanes; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005541:Forced Expiratory Volume / Q000502:physiology; D006801:Humans; D011237:Predictive Value of Tests; D011788:Quality of Life; D011804:Quinolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013440:Sulfides; D016896:Treatment Outcome
chemical_list: D000085:Acetates; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; D019819:Budesonide; C093875:montelukast