Long-term Inhaled Corticosteroids in Preschool Children at High Risk for Asthma

Guilbert TW, Morgan WJ, Zeiger RS, et al. N Engl J Med. 2006;354:1985–1997 PURPOSE OF THE STUDY. To determine the role of inhaled corticosteroid (ICS) in preventing the development of asthma in a group of high-risk children before the development of symptomatic disease or abnormal lung function. STUDY POPULATION. Subjects were 285 children aged 2 to 3 years at high risk for developing asthma. METHODS. Subjects were assigned to fluticasone propionate (FP) 88 μg twice per day with a pressurized metered-dose inhaler with spacer or placebo for a 2-year treatment period. The patients were observed without treatment for 1 year. RESULTS. During the 2-year treatment period, there was significant improvement in symptom-free days for those in the FP group (86.8%–85.9%). Children in the FP group had more episode-free days, decreased exacerbations, and decreased need for extra controller medication. Those in the ICS group had a 1.1-cm decrement in growth after the first 2 years of the study, but this difference decreased to 0.7 cm after the 1-year observation period. CONCLUSIONS. Although ICS had a significant effect on the burden of asthma during the treatment period, there was no evidence that a long-term effect was carried over to the 1-year observation period. REVIEWER COMMENTS. The burden of childhood asthma is benefited with administration of ICS, but there is no evidence that long-term disease modification occurs.