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

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

Author information

  • 1Division of Pediatric Pulmonary Medicine, Arizona Respiratory Center, University of Arizona, Tucson, AZ 85724, USA. guilbert@arc.arizona.edu

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.).

Copyright 2006 Massachusetts Medical Society.

PMID:
16687711
[PubMed - indexed for MEDLINE]
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