Montelukast - evaluation in 6 to 14 years old children with persistent asthma - pediatric montelukast study group

Indian J Pediatr. 2004 Sep;71(9):811-5. doi: 10.1007/BF02730720.


Objective: The suffering of children with asthma as a persistent illness is present in approximately 10% of the total population. The prevalent treatment regimens available has been the inhaled coticosteroids and short acting bronchodialators. Though the therapies are rational and well accepted but at the cost of side effects on chronic use. The changing definitions and guidelines with regard to asthma have given a classified slot to newer treatments like leukotriene receptor antagonists (LTRAs). The aim of the present study was to study the efficacy and tolerability of montelukast in the treatment of Indian pediatric patients aged 6 to 14 years with chronic asthma.

Methods: It was a prospective, open, non-comparative multicentric study. 881 Children (Mean age 11.83+/- 3.12 years) were included. Patients fulfilling the inclusion criteria were given one mouth dissolving 5 mg montelukast tablet daily in the evening for 30 days.

Results: There was an overall improvement in all the efficacy parameters. The daytime total asthma score decreased from 9.55 +/- 1.52 to 3.59 +/- 2.10. The average number of asthma attacks over the last 4 weeks decreased from 1.14+/- 1.19 to 0.28+/-0.57. The number of nocturnal awakenings fell from 1.54+/-0.78 to 0.43+/-0.54. FEV1 (L) [Predicted] improved by 21.18%). PEFR (L/min.) improved by 34.69%). Approximately 45% physicians rated the treatment as excellent, 30% as very good, 18% as good, 7% as fair and none as poor.

Conclusion: Montelukast administered once daily improved efficacy end-points and was well tolerated in pediatric patients with chronic persistent asthma establishing itself as a valuable treatment option to current asthma therapies in 6 to 14 years old patients.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Acetates / therapeutic use*
  • Administration, Oral
  • Adolescent
  • Anti-Asthmatic Agents / therapeutic use*
  • Asthma / drug therapy*
  • Child
  • Drug Administration Schedule
  • Female
  • Humans
  • Male
  • Prospective Studies
  • Quinolines / therapeutic use*


  • Acetates
  • Anti-Asthmatic Agents
  • Quinolines
  • montelukast