Short-course montelukast for intermittent asthma in children: a randomized controlled trial

Am J Respir Crit Care Med. 2007 Feb 15;175(4):323-9. doi: 10.1164/rccm.200510-1546OC. Epub 2006 Nov 16.


Rationale: In children, intermittent asthma is the most common pattern and is responsible for the majority of exacerbations. Montelukast has a rapid onset of action and may be effective if used intermittently.

Objectives: To determine whether a short course of montelukast in children with intermittent asthma would modify the severity of an asthma episode.

Methods: Children, aged 2-14 years with intermittent asthma participated in this multicenter, randomized, double-blind, placebo-controlled clinical trial over a 12-month period. Treatment with montelukast or placebo was initiated by parents at the onset of each upper respiratory tract infection or asthma symptoms and continued for a minimum of 7 days or until symptoms had resolved for 48 hours.

Measurements and main results: A total of 220 children were randomized, 107 to montelukast and 113 to placebo. There were 681 treated episodes (345 montelukast, 336 placebo) provided by 202 patients. The montelukast group had 163 unscheduled health care resource utilizations for asthma compared with 228 in the placebo group (odds ratio, 0.65; 95% confidence interval, 0.47-0.89). There was a nonsignificant reduction in specialist attendances and hospitalizations, duration of episode, and beta-agonist and prednisolone use. Symptoms were reduced by 14% and nights awakened by 8.6% (p = 0.043), and days off from school or childcare by 37% and parent time off from work by 33% (p < 0.0001 for both).

Conclusions: A short course of montelukast, introduced at the first signs of an asthma episode, results in a modest reduction in acute health care resource utilization, symptoms, time off from school, and parental time off from work in children with intermittent asthma.

Publication types

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

MeSH terms

  • Absenteeism
  • Acetates / therapeutic use*
  • Adolescent
  • Adrenergic beta-Agonists / therapeutic use
  • Anti-Asthmatic Agents / therapeutic use*
  • Asthma / drug therapy*
  • Asthma / economics
  • Child
  • Child, Preschool
  • Cyclopropanes
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Utilization / statistics & numerical data
  • Emergency Service, Hospital / statistics & numerical data
  • Female
  • Glucocorticoids / therapeutic use
  • Hospitalization / statistics & numerical data
  • Humans
  • Male
  • Office Visits / statistics & numerical data
  • Physicians, Family / statistics & numerical data
  • Prednisolone / therapeutic use
  • Quinolines / therapeutic use*
  • Severity of Illness Index
  • Sulfides
  • Treatment Outcome


  • Acetates
  • Adrenergic beta-Agonists
  • Anti-Asthmatic Agents
  • Cyclopropanes
  • Glucocorticoids
  • Quinolines
  • Sulfides
  • Prednisolone
  • montelukast