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Pediatric Infectious Disease Journal:
doi: 10.1097/01.inf.0000437807.83845.d6
Original Studies

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

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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.

© 2014 by Lippincott Williams & Wilkins, Inc.


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