Effectiveness of nebulized beclomethasone in preventing viral wheezing: an RCT

The goal of this study was to evaluate the effectiveness of nebulized beclomethasone in preventing the recurrence of viral wheezing. METHODS: The study was designed as a randomized, double-blind, placebo-controlled trial. Outpatient children aged 1 to 5 years with at least 1 episode of viral wheezing in the last 12 months, presenting to any of 40 Italian pediatricians for an upper respiratory tract infection, were randomly allocated to receive beclomethasone 400 mg or placebo twice daily for 10 days. Medications were administered through a nebulizer. A clinical evaluation was performed by the pediatrician at the start and end of the treatment period. A subjective evaluation of symptoms and efficacy of treatment was performed by the parents. The primary endpoint was the incidence of viral wheezing diagnosed by the pediatricians during the 10-day treatment period. RESULTS: A total of 525 children were enrolled in the study, 521 of whom were visited at the end of the treatment period. Wheezing was diagnosed by the pediatricians in 47 children (9.0% (95% confi- dence interval: 6.7 to 11.3)), with no statistically significant differences between treatment groups (beclomethasone versus placebo relative risk: 0.61 (95% confidence interval: 0.35 to 1.08)).The treatment was considered helpful by 63% of parents (64% in the beclomethasone group vs 61% in the placebo group). In all, 46% of children still had infection symptoms at the end of the treatment period, with no differ- ences between groups. CONCLUSIONS: The findings from this study confirm that inhaled ste- roids are not effective in preventing recurrence of viral wheezing. Moreover, no benefits were found in reducing symptoms of respiratory tract infections. Pediatrics 2014;133:e505-e512 ABBREVIATIONS CI—confidence interval RCT—randomized controlled trial RR—relative risk URTI—upper respiratory tract infection Dr Clavenna conceptualized and designed the study, and drafted the initial manuscript; Drs Sequi and Cartabia conducted the statistical analyses, and reviewed and revised the manuscript; Drs Borghi and Fortinguerra were involved in the data management and reviewed and revised the manuscript; and Dr Bonati contributed to defining the protocol, supervised the study, and reviewed and revised the manuscript. All authors approved the final manuscript as submitted.