Efficacy of Nebulised Beclometasone in Viral Wheezing Prophylaxis

Phase 4 Completed 576 enrolled Mario Negri Institute for Pharmacological Research Agenzia Italiana del Farmaco · collab Associazione Culturale Pediatri · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

Inhaled steroids, in particular beclomethasone, are widely prescribed in Italy as symptomatic treatment of upper respiratory infections without evidence of efficacy. The purpose of this study is to evaluate the efficacy of beclomethasone (administered by nebuliser twice a day) in preventing viral wheezing in pre-school children who had had episodes in the preceding 12 months.

Timeline

Start: 2010-10
Primary completion: 2012-03
Completion: 2012-10

Outcome

Missed primary endpoint

paper Wheezing was diagnosed by the pediatricians in 47 children (9.0% [95% confidence interval: 6.7 to 11.3]), with no statistically significant differences between treatment groups PMID 24534400 ↗

Publications

Results Clavenna A, Sequi M, Cartabia M, Fortinguerra F, Borghi M, Bonati M; ENBe Study Group. Effectiveness of nebulized beclomethasone in preventing viral wheezing: an RCT. Pediatrics. 2014 Mar;133(3):e505-12. doi: 10.1542/peds.2013-2404. Epub 2014 Feb 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Beclomethasone	Small molecule	400 ug	—