OBJECTIVE: To determine whether inhaled corticosteroid therapy given for 3 months after mild bronchiolitis decreases the incidence and/or severity of wheezing in the following 12 months. DESIGN: Multicentric, single-blind, controlled, randomised intervention study. SETTING: Primary Health Care Centers in Lezo, Beraun, Andoain and Irún (Gipuzkoa, Spain). PATIENTS: Infants less than 12 months old (n = 94) diagnosed with mild bronchiolitis. INTERVENTION: We established two groups of patients: group 1 (n = 47) was treated with inhaled beclomethasone (250 pg/12 hours) using a valved holding chamber (Babyhaler); the treatment started eight days after diagnosis of bronchiolitis and lasted 3 months. Group 2 (n = 47) received no treatment. We compared the number of wheezing episodes and their severity during the intervention period (3 months) and the follow-up period (12 months) with the Students t-test and the Chi-squared test. RESULTS: We studied 89 infants (group 1, n = 42; group 2, n = 47), 67% of whom wheezed during the study period (15 months). There were no significant differences between the treatment and the control group in the study periods. CONCLUSIONS:Inhaled beclomethasone given for 3 months does not significantly modify the occurrence of wheezing episodes during the treatment period or during the following 12 months.
RCT Entities:
OBJECTIVE: To determine whether inhaled corticosteroid therapy given for 3 months after mild bronchiolitis decreases the incidence and/or severity of wheezing in the following 12 months. DESIGN: Multicentric, single-blind, controlled, randomised intervention study. SETTING: Primary Health Care Centers in Lezo, Beraun, Andoain and Irún (Gipuzkoa, Spain). PATIENTS: Infants less than 12 months old (n = 94) diagnosed with mild bronchiolitis. INTERVENTION: We established two groups of patients: group 1 (n = 47) was treated with inhaled beclomethasone (250 pg/12 hours) using a valved holding chamber (Babyhaler); the treatment started eight days after diagnosis of bronchiolitis and lasted 3 months. Group 2 (n = 47) received no treatment. We compared the number of wheezing episodes and their severity during the intervention period (3 months) and the follow-up period (12 months) with the Students t-test and the Chi-squared test. RESULTS: We studied 89 infants (group 1, n = 42; group 2, n = 47), 67% of whom wheezed during the study period (15 months). There were no significant differences between the treatment and the control group in the study periods. CONCLUSIONS: Inhaled beclomethasone given for 3 months does not significantly modify the occurrence of wheezing episodes during the treatment period or during the following 12 months.
Authors: Ricardo M Fernandes; Liza M Bialy; Ben Vandermeer; Lisa Tjosvold; Amy C Plint; Hema Patel; David W Johnson; Terry P Klassen; Lisa Hartling Journal: Cochrane Database Syst Rev Date: 2013-06-04