The effect of montelukast and different doses of budesonide on IgE serum levels and clinical parameters in children with newly diagnosed asthma

Pulm Pharmacol Ther. 2005;18(5):374-80. doi: 10.1016/j.pupt.2005.02.002. Epub 2005 Apr 26.


Background: Since IgE is considered to play a crucial role in allergic immune responses, the reduction of free IgE level has been an attractive target in the treatment of allergic diseases. The present study was conducted to determine the effects of a 6-month treatment with different doses of inhaled budesonide and montelukast sodium in children with newly diagnosed atopic asthma.

Methods: In this randomized, double-blind, double-dummy trial, 51 children with newly diagnosed asthma and sensitivity to house-dust mites were randomly allocated to receive budesonide (in two different doses 400 or 800 mcg) or montelukast for 6 months. The primary end point was the level of serum total and specific IgE before and after treatment. The secondary end points were clinical parameters and forced expiratory volume in 1s (FEV1).

Results: After 6 months of treatment, a high dose of inhaled corticosteroid and montelukast, significantly decreased levels of total and specific IgE. Medium dose of inhaled corticosteroid had no effect on total and specific IgE serum level. Clinical score and FEV1 significantly improved after 6 months of treatment with medium (P = 0.002) and high dose (P = 0.001) of inhaled budesonide and montelukast (P = 0.002). There were no differences between groups in changes of all clinical parameters after treatment.

Conclusion: Only high doses of inhaled corticosteroids and montelukast decreased the serum IgE levels. Perhaps long-term treatment with montelukast will be beneficial to asthma patients by decreasing IgE levels.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Acetates / administration & dosage
  • Acetates / therapeutic use*
  • Administration, Inhalation
  • Administration, Oral
  • Adolescent
  • Anti-Asthmatic Agents / administration & dosage
  • Anti-Asthmatic Agents / therapeutic use*
  • Antigens, Dermatophagoides / immunology
  • Asthma / blood
  • Asthma / drug therapy*
  • Asthma / pathology
  • Budesonide / administration & dosage
  • Budesonide / therapeutic use*
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Humans
  • Immunoglobulin E / blood*
  • Male
  • Quinolines / administration & dosage
  • Quinolines / therapeutic use*
  • Severity of Illness Index
  • Treatment Outcome


  • Acetates
  • Anti-Asthmatic Agents
  • Antigens, Dermatophagoides
  • Quinolines
  • Immunoglobulin E
  • Budesonide
  • montelukast