Preemptive Use of High-Dose Fluticasone for Virus-Induced Wheezing in Young Children

BACKGROUND: Although virus-induced wheezing is common in preschool-age children, optimal management remains elusive. We examined the efficacy and safety of preemptive treatment with high-dose fluticasone in reducing the severity of recurrent virus-induced wheezing in children. METHODS: We randomly assigned 129 children who were 1 to 6 years of age to receive 750 microg of fluticasone propionate (ex-valve manufacturer-measured dose) or placebo twice daily, beginning at the onset of an upper respiratory tract infection and continuing for a maximum of 10 days, over a period of 6 to 12 months. The primary outcome was rescue oral corticosteroid use. Secondary outcomes included symptoms, use of beta(2)-agonists, acute care visits, hospitalizations, discontinuation of the study drug, change in growth and bone mineral density, basal cortisol level, and adverse events. RESULTS: Over a median period of 40 weeks, 8% of upper respiratory tract infections in the fluticasone group led to treatment with rescue systemic corticosteroids, as compared with 18% in the placebo group (odds ratio, 0.49; 95% confidence interval CI, 0.30 to 0.83). Children who were treated with fluticasone, as compared with those who were given placebo, had smaller mean (+/-SD) gains from baseline in height (6.23+/-2.62 cm unadjusted value; z score, -0.19 +/-0.42 vs. 6.56+/-2.90 cm unadjusted value; z score, 0.00+/-0.48; difference between groups in z score from baseline to end point, -0.24 95% CI, -0.40 to -0.08) and in weight (1.53+/-1.17 kg unadjusted value; z score, -0.15+/-0.48 vs. 2.17+/-1.79 kg unadjusted value; z score, 0.11+/-0.43; difference between groups in z score from baseline to end point, -0.26 95% CI, -0.41 to -0.09). There were no significant differences between the groups in basal cortisol level, bone mineral density, or adverse events. CONCLUSIONS: In preschool-age children with moderate-to-severe virus-induced wheezing, preemptive treatment with high-dose fluticasone as compared with placebo reduced the use of rescue oral corticosteroids. Treatment with fluticasone was associated with a smaller gain in height and weight. Given the potential for overuse, this preventive approach should not be adopted in clinical practice until long-term adverse effects are clarified. (ClinicalTrials.gov number, NCT00238927.)