Objectives To evaluate the efficacy of nebulised beclometasone in preventing the recurrence of viral wheezing. Patients and methods The ENBe study was designed in two phase: a randomized double blind placebo-controlled trial (phase I) followed by an observational follow-up period (phase II). Only phase I will be described in this paper. Outpatient children 1-5 years old with upper respiratory tract infection and at least one episode of viral wheezing in the last 12 months were randomly allocated to receive nebulised beclometasone 400 μg or placebo twice daily for 10 days. 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 and 521 of which were visited at the end of the treatment period. Wheezing was diagnosed by pediatricians in 47 children (9.0%) with no statistically significant differences between treatment groups (beclometasone vs placebo relative risk=0.61, 95%CI 0.35-1.08). No differences were found regarding the asthma-like symptom score, while 63% of parents rated the treatment as helpful (64% in beclometasone versus 61% in placebo group). In all, 46% of children had still infection symptoms at the end of the treatment period, without differences between groups. Conclusions The findings from this study confirm that inhaled steroids are not effective in preventing viral wheezing recurrence. Moreover, no benefits were found in reducing symptoms of respiratory tract infections.
|Number of pages||8|
|Publication status||Published - 2013|
ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health