OBJECTIVE: 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 μg 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% confidence 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 differences between groups. CONCLUSIONS: The findings from this study confirm that inhaled steroids are not effective in preventing recurrence of viral wheezing. Moreover, no benefits were found in reducing symptoms of respiratory tract infections.
RCT Entities:
OBJECTIVE: 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. Outpatientchildren 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 μg 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% confidence 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 differences between groups. CONCLUSIONS: The findings from this study confirm that inhaled steroids are not effective in preventing recurrence of viral wheezing. Moreover, no benefits were found in reducing symptoms of respiratory tract infections.
Authors: Manon Belhassen; Jacques De Blic; Laurent Laforest; Valérie Laigle; Céline Chanut-Vogel; Liliane Lamezec; Jacques Brouard; Brigitte Fauroux; Gérard de Pouvourville; Marine Ginoux; Eric Van Ganse Journal: Medicine (Baltimore) Date: 2016-04 Impact factor: 1.889
Authors: Maria P White; Tessa K Kolstad; Molly Elliott; Elizabeth S Cochrane; David C Stamey; Jason S Debley Journal: J Asthma Allergy Date: 2020-01-07
Authors: Marzia Duse; Francesca Santamaria; Maria Carmen Verga; Marcello Bergamini; Giovanni Simeone; Lucia Leonardi; Giovanna Tezza; Annamaria Bianchi; Annalisa Capuano; Fabio Cardinale; Giovanni Cerimoniale; Massimo Landi; Monica Malventano; Mariangela Tosca; Attilio Varricchio; Anna Maria Zicari; Carlo Alfaro; Salvatore Barberi; Paolo Becherucci; Roberto Bernardini; Paolo Biasci; Carlo Caffarelli; Valeria Caldarelli; Carlo Capristo; Serenella Castronuovo; Elena Chiappini; Renato Cutrera; Giovanna De Castro; Luca De Franciscis; Fabio Decimo; Iride Dello Iacono; Lucia Diaferio; Maria Elisa Di Cicco; Caterina Di Mauro; Cristina Di Mauro; Dora Di Mauro; Francesco Di Mauro; Gabriella Di Mauro; Mattia Doria; Raffaele Falsaperla; Valentina Ferraro; Vassilios Fanos; Elena Galli; Daniele Giovanni Ghiglioni; Luciana Indinnimeo; Ahmad Kantar; Adima Lamborghini; Amelia Licari; Riccardo Lubrano; Stefano Luciani; Francesco Macrì; Gianluigi Marseglia; Alberto Giuseppe Martelli; Luigi Masini; Fabio Midulla; Domenico Minasi; Vito Leonardo Miniello; Michele Miraglia Del Giudice; Sergio Renzo Morandini; Germana Nardini; Agostino Nocerino; Elio Novembre; Giovanni Battista Pajno; Francesco Paravati; Giorgio Piacentini; Cristina Piersantelli; Gabriella Pozzobon; Giampaolo Ricci; Valter Spanevello; Renato Turra; Stefania Zanconato; Melissa Borrelli; Alberto Villani; Giovanni Corsello; Giuseppe Di Mauro; Diego Peroni Journal: Ital J Pediatr Date: 2021-04-21 Impact factor: 2.638