Can montelukast shorten prednisolone therapy in children with mild to moderate acute asthma? A randomized controlled trial

J Pediatr. 2009 Dec;155(6):795-800. doi: 10.1016/j.jpeds.2009.06.008. Epub 2009 Aug 4.


Objective: To examine whether outpatient post-stabilization therapy with montelukast produces more treatment failures than prednisolone.

Study design: In this randomized, double-blind, double-dummy non-inferiority trial, 130 children 2 to 17 years of age with mild to moderate acute asthma stabilized with prednisolone in the emergency department received 5 daily treatments with either prednisolone or montelukast after discharge. The primary outcome was treatment failure within 8 days (ie, an asthma-related unscheduled visit, hospitalization, or additional systemic corticosteroids).

Results: The rates of treatment failure were 7.9% in the prednisolone group and 22.4% in the montelukast group (95% CI, 26.5%-2.4%). Treatment was more likely to fail in younger patients (odds ratio, 4.9). In the montelukast group, more patients received additional pharmacotherapy than in patients receiving prednisolone (23.9% versus 9.5%, P = .03). The differences in the daily salbutamol treatments, asymptomatic days, and changes in the Pediatric Respiratory Assessment Measure score were not significant (P = .85, .75, and .26, respectively).

Conclusion: Montelukast does not represent an adequate alternative to corticosteroids after outpatient stabilization in mild to moderate acute asthma. This population should receive oral corticosteroids after discharge.

Trial registration: NCT00213252.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetates / administration & dosage*
  • Adolescent
  • Anti-Inflammatory Agents / administration & dosage*
  • Asthma / complications
  • Asthma / drug therapy*
  • Bronchodilator Agents / administration & dosage
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Emergency Service, Hospital
  • Female
  • Hospitalization
  • Humans
  • Leukotriene Antagonists / administration & dosage*
  • Male
  • Prednisolone / administration & dosage*
  • Quinolines / administration & dosage*
  • Treatment Outcome


  • Acetates
  • Anti-Inflammatory Agents
  • Bronchodilator Agents
  • Leukotriene Antagonists
  • Quinolines
  • Prednisolone
  • montelukast

Associated data