title: Intermittent or daily montelukast versus placebo for episodic asthma in children.
abstract: BACKGROUND
  No standard, optimal treatment exists for severe intermittent (ie, episodic) asthma in children. However, evidence suggests that both daily and episode-driven montelukast are effective for this phenotype.
  
  
  OBJECTIVE
  To assess the regimen-related efficacy of montelukast in treating pediatric episodic asthma.
  
  
  METHODS
  A multicenter, randomized, double-blind, double-dummy, parallel-group, 52-week study was performed in children 6 months to 5 years of age comparing placebo with two regimens of montelukast 4 mg: (1) daily; or (2) episode-driven for 12 days beginning with signs/symptoms consistent with imminent cold or breathing problem. The main outcome measure was the number of asthma episodes (symptoms requiring treatment) culminating in an asthma attack (symptoms requiring physician visit, emergency room visit, corticosteroids, or hospitalization).
  
  
  RESULTS
  Five hundred eighty-nine patients were randomized to daily montelukast, 591 to intermittent montelukast, and 591 to placebo. Compared with placebo, no significant difference was seen between daily montelukast (P = .510) or intermittent montelukast (P = .884) in the number of asthma episodes culminating in an asthma attack over 1 year. Daily montelukast reduced symptoms over the 12-day treatment period of asthma episodes compared with placebo (P = .045). Beta-agonist use was reduced with both daily (P = .048) and intermittent montelukast (P = .028) compared with placebo. However, because of prespecified rules for multiplicity adjustments (requiring a positive primary endpoint), statistical significance for secondary endpoints cannot be concluded. All treatments were well tolerated.
  
  
  CONCLUSIONS
  Montelukast did not reduce the number of asthma episodes culminating in an asthma attack over 1 year in children 6 months to 5 years of age, although numerical improvements occurred in some endpoints.
authors.affiliation: Allergy Clinic, Suomen Terveystalo AllergyClinic, Turku, Finland. erkka.valovirta@terveystalo.com
authors.forename: Erkka
authors.initials: E
authors.lastname: Valovirta
authors.forename: Maria L
authors.initials: ML
authors.lastname: Boza
authors.forename: Colin F
authors.initials: CF
authors.lastname: Robertson
authors.forename: Nadia
authors.initials: N
authors.lastname: Verbruggen
authors.forename: Steven S
authors.initials: SS
authors.lastname: Smugar
authors.forename: Linda M
authors.initials: LM
authors.lastname: Nelsen
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Knorr
authors.forename: Theodore F
authors.initials: TF
authors.lastname: Reiss
authors.forename: George
authors.initials: G
authors.lastname: Philip
authors.forename: Deborah M
authors.initials: DM
authors.lastname: Gurner
mesh_terms: D000085:Acetates / Q000008:administration & dosage* / Q000627:therapeutic use; D000284:Administration, Oral; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy*; D002675:Child, Preschool; D003521:Cyclopropanes; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010919:Placebos; D011804:Quinolines / Q000008:administration & dosage* / Q000627:therapeutic use; D013440:Sulfides; D016896:Treatment Outcome
chemical_list: D000085:Acetates; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D010919:Placebos; D011804:Quinolines; D013440:Sulfides; C093875:montelukast