Long-term inhaled corticosteroids in preschool children at high risk for asthma

N Engl J Med. 2006 May 11;354(19):1985-97. doi: 10.1056/NEJMoa051378.

Abstract

Background: It is unknown whether inhaled corticosteroids can modify the subsequent development of asthma in preschool children at high risk for asthma.

Methods: We randomly assigned 285 participants two or three years of age with a positive asthma predictive index to treatment with fluticasone propionate (at a dose of 88 mug twice daily) or masked placebo for two years, followed by a one-year period without study medication. The primary outcome was the proportion of episode-free days during the observation year.

Results: During the observation year, no significant differences were seen between the two groups in the proportion of episode-free days, the number of exacerbations, or lung function. During the treatment period, as compared with placebo use, use of the inhaled corticosteroid was associated with a greater proportion of episode-free days (P=0.006) and a lower rate of exacerbations (P<0.001) and of supplementary use of controller medication (P<0.001). In the inhaled-corticosteroid group, as compared with the placebo group, the mean increase in height was 1.1 cm less at 24 months (P<0.001), but by the end of the trial, the height increase was 0.7 cm less (P=0.008). During treatment, the inhaled corticosteroid reduced symptoms and exacerbations but slowed growth, albeit temporarily and not progressively.

Conclusions: In preschool children at high risk for asthma, two years of inhaled-corticosteroid therapy did not change the development of asthma symptoms or lung function during a third, treatment-free year. These findings do not provide support for a subsequent disease-modifying effect of inhaled corticosteroids after the treatment is discontinued. (ClinicalTrials.gov number, NCT00272441.).

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Administration, Inhalation
  • Analysis of Variance
  • Androstadienes / administration & dosage*
  • Asthma / drug therapy
  • Asthma / prevention & control*
  • Bronchodilator Agents / administration & dosage*
  • Child, Preschool
  • Disease Progression
  • Disease-Free Survival
  • Female
  • Fluticasone
  • Growth / drug effects
  • Humans
  • Male
  • Regression Analysis
  • Respiratory Physiological Phenomena / drug effects
  • Respiratory Sounds / drug effects*
  • Risk Factors
  • Treatment Outcome

Substances

  • Androstadienes
  • Bronchodilator Agents
  • Fluticasone

Associated data

  • ClinicalTrials.gov/NCT00272441