▶ Objectives. To evaluate the efficacy of nebulised beclometasone in preventing the recurrence of viral wheezing. ▶ Methods. The ENBe study was designed in two phases: 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. The study population was represented by outpatient children 1-5 years old with upper respiratory tract infection and at least one episode of viral wheezing in the last 12 months. Participants were randomly allocated to receive nebulised beclometasone 400 mcg or placebo twice daily for 10 days. A clinical evaluation was performed by the family paediatrician at the start and end of the treatment period. Parents recorded and rated the intensity of symptoms on a diary and provided a subjective evaluation of treatment efficacy. The incidence of viral wheezing diagnosed by the paediatricians during the 10 day treatment period represented the primary endpoint. ▶ Results. A total of 525 children were enrolled in the study and 521 of which were visited at the end of the treatment period. In all, 47 children (9.0%) had a wheezing recurrence diagnosed by paediatricians 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.
|Translated title of the contribution||Beclomethasone shows little efficacy in preventing viral wheezing. Results of the ENBe study|
|Number of pages||7|
|Journal||Ricerca e Pratica|
|Publication status||Published - 2013|
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