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Lack of Long-term Effects of High-dose Inhaled Beclomethasone for Respiratory Syncytial Virus Bronchiolitis: A Randomized Placebo-controlled Trial

Zomer-Kooijker, Kim MD*; van der Ent, Cornelis K. MD, PhD*; Ermers, Marieke J.J. MD, PhD; Rovers, Maroeska M. MD, PhD; Bont, Louis J. MD, PhD§¶on behalf of the RSV Corticosteroid Study Group

The Pediatric Infectious Disease Journal: January 2014 - Volume 33 - Issue 1 - p 19–23
doi: 10.1097/01.inf.0000437807.83845.d6
Original Studies

Background: Previously, we showed that high-dose early initiated inhaled corticosteroids during respiratory syncytial virus bronchiolitis partially and transiently prevents subsequent recurrent wheeze. Here, we study treatment effect on lung function at age 6.

Methods: This is a 6-year follow-up report of a randomized placebo-controlled trial, in which 185 infants hospitalized for respiratory syncytial virus bronchiolitis were treated with early initiated, high-dose inhaled beclomethasone (n = 86) or placebo (n = 99) for 3 months. The primary outcome was forced expiratory volume in 1 second as percentage predicted. Secondary outcomes were bronchial hyperresponsiveness, physician-diagnosed asthma, hay fever and eczema. Possible toxicity was assessed by linear growth measurements.

Results: At age 6, no significant differences were found in mean forced expiratory volume in 1 second percentage predicted between beclomethasone-treated and placebo-treated patients (91.4 vs. 93.4, mean difference 2.05 (95% confidence interval: −1.98 to 6.08). The proportion of bronchial hyperresponsiveness, physician-diagnosed asthma, parent reported hay fever and eczema was comparable between groups. There were no differences in linear growth.

Conclusions: Early initiated prolonged treatment with high-dose inhaled beclomethasone during hospitalization for respiratory syncytial virus infection during infancy did not improve the long-term respiratory outcome, but was safe.

From the *Department of Pediatric Pulmonology and Allergology, Wilhelmina Children’s Hospital; Department of Psychiatry, University Medical Centre Utrecht; Department of Epidemiology, Biostatistics & HTA and operating rooms, Radboud University Medical Centre Nijmegen; §Department of Pediatric Immunology and Infectious Diseases, Wilhelmina Children’s Hospital; and Department of Immunology, University Medical Centre Utrecht, The Netherlands.

Accepted for publication August 8, 2013.

The trial registration was Current Controlled Trials ISRCTN12352714.

L.B. has received financial support for the submitted work from a grant from the Dutch Asthma Foundation (No 3.2.03.22) and an unrestricted grant from Teva Pharma Nederland. The authors declare no other funding or conflicts of interest to declare.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (www.pidj.com).

Address for correspondence: Louis J. Bont, MD, PhD, University Medical Centre Utrecht, Wilhelmina Children’s Hospital, Pediatric Immunology and Infectious Diseases, Room C02.417, PO Box 85090, 3508 AB Utrecht, The Netherlands. E-mail: l.bont@umcutrecht.nl.

© 2014 by Lippincott Williams & Wilkins, Inc.