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Long-term inhaled corticosteroids in preschool children at high risk for asthma
Theresa W Guilbert1, Wayne J Morgan, Robert S Zeiger
1Division of Pediatric Pulmonary Medicine, Arizona Respiratory Center, University of Arizona, Tucson, AZ 85724, USA. guilbert@arc.arizona.edu
Insights
Inhaled corticosteroids did not alter long-term asthma development in high-risk preschoolers. Two years of treatment did not modify asthma symptoms or lung function after discontinuation.
Area of Science:
- Pediatric Pulmonology
- Allergy and Immunology
- Clinical Pharmacology
Background:
- Asthma development in high-risk preschool children remains a significant clinical concern.
- The potential disease-modifying effects of early inhaled corticosteroid (ICS) intervention are not well-established.
- Investigating ICS in preschool children is crucial for understanding long-term asthma trajectories.
Purpose of the Study:
- To determine if two years of inhaled fluticasone propionate modifies subsequent asthma development in high-risk preschool children.
- To assess the impact of ICS on asthma symptoms, exacerbations, and lung function during and after treatment.
Main Methods:
- A randomized, placebo-controlled trial involving 285 preschool children (2-3 years) with a positive asthma predictive index.
- Participants received fluticasone propionate (88 mcg twice daily) or placebo for two years, followed by a one-year observation period without medication.
- The primary outcome was the proportion of episode-free days during the observation year.
Main Results:
- During the treatment period, ICS significantly reduced asthma symptoms, exacerbations, and controller medication use compared to placebo.
- However, ICS treatment was associated with a temporary reduction in growth velocity.
- During the one-year post-treatment observation, no significant differences in episode-free days, exacerbations, or lung function were observed between the ICS and placebo groups.
Conclusions:
- Two years of ICS therapy in high-risk preschool children did not alter asthma symptom development or lung function in the subsequent treatment-free year.
- These findings suggest that ICS therapy in this population does not confer a sustained disease-modifying effect after discontinuation.
- Further research may be needed to explore alternative or longer-term strategies for asthma prevention in high-risk children.
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.).
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