Abstract
Methods This is a randomized, pilot study, involving infants ≤ 1 year of age hospitalized due to acute viral bronchiolitis. All patients with moderate-severe bronchiolitis (Wang score ≥ 8) are eligible to initiate the study. At hospital discharge, recruited patients are randomized into three study groups conventional treatment, oral montelukast (MK) or inhaled beclomethasone dipropionate (BDP) and directed to monthly follow-up appointments for 6 months. We aim to determine the potential benefit of inhaled BDP and oral MK in the natural history of post bronchiolitis wheezing. The primary variables are: need of hospitalization and number of visits to the emergency department (ED). The secondary variables are: number of days until first exacerbation, duration of hospitalization, number of asymptomatic days and need of bronchodilator and/or oral corticosteroid.
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