Efficacy of nebulized budesonide in treatment of severe infantile asthma: a double-blind study

J Allergy Clin Immunol. 1996 Jul;98(1):14-20. doi: 10.1016/s0091-6749(96)70221-x.


Background and objective: Treatments with inhaled corticosteroids yielded conflicting results in infants with severe asthma. The purpose of this study was to assess the efficacy of nebulized budesonide on the control of asthma in this age group.

Methods: In a double-blind, placebo-controlled study, 40 infants with severe asthma received either nebulized budesonide (1 mg) or placebo twice daily for 12 weeks, followed by a follow-up period of up to 12 weeks. A jet nebulizer driven by an air compressor was used to administer budesonide and placebo.

Results: Fewer patients in the budesonide group had an exacerbation during the treatment period (40%) compared with the placebo group (83%, p < 0.01). The duration of oral steroid therapy was shorter in the budesonide group than in the placebo group (median number of days of exacerbation as a proportion of the total treatment time, 0% vs 14.5%; p < 0.05). The incidence of daytime (p < 0.05) and nighttime wheezing (p < 0.01) was lower in the budesonide group than in the placebo group during the treatment period. The proportion of patients without an exacerbation of asthma during the entire 24 weeks was 28% for those patients who had received budesonide and 0% for those patients who had received placebo. Asthma improved in more patients in the budesonide group (17 and 19, 89%) than in the placebo group (7 of 16, 44%; p < 0.005). These results should improve and modify the treatment of infants with severe asthma.

Conclusion: Nebulized budesonide (1 mg twice daily) is a well-tolerated and efficient treatment for severe infantile asthma.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Aerosols
  • Asthma / drug therapy*
  • Bronchodilator Agents / administration & dosage
  • Bronchodilator Agents / therapeutic use
  • Budesonide
  • Child, Preschool
  • Double-Blind Method
  • Female
  • Humans
  • Infant
  • Male
  • Nebulizers and Vaporizers
  • Pregnenediones / administration & dosage
  • Pregnenediones / therapeutic use*


  • Aerosols
  • Bronchodilator Agents
  • Pregnenediones
  • Budesonide