Lack of Long Term Effects of High Dose Inhaled Beclomethasone for RSV Bronchiolitis - A Randomized Placebo-Controlled Trial

BACKGROUND:: Previously we showed that high-dose early initiated inhaled corticosteroids during respiratory syncytial virus (RSV) 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 RSV 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 one second as percentage (%) predicted. Secondary outcomes were bronchial hyperresponsiveness, physician diagnosed asthma, hay fever and eczema. Possible toxity was assessed by linear growth measurements.

RESULTS:: At age 6, no significant differences were found in mean FEV1% predicted between beclomethasone-treated and placebo-treated patients (91.4 versus 93.4, mean difference 2.05 (95% CI -1.98 to 6.08). The proportion of bronchial hyperresponsiveness, physician diagnosed asthma, parent reported hay fever and eczema were comparable between groups. There were no differences in linear growth.

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