Abstract

To evaluate the long-term effect of montelukast on symptoms of cough and wheeze following RSV bronchiolitis. Fifty eight patients (aged < or = 24 months) hospitalized with a first episode of RSV bronchiolitis were enrolled in this double blind prospective randomized trial comparing montelukast (n = 31) vs placebo (n = 27). During the 3-month treatment period, there were no statistical significant differences between the two groups for symptom-free days and nights (48.5 [interquartile range 33.0.0-66.0] for montelukast vs 57.0 [29.0-71.0] for placebo p = 0.415) nor disease-free days and nights (44.5 days [26.0-54.0] vs 53.0 [22.3-71.0]; p = 0.266). During the 1 year follow-up, there were 41 exacerbations in the montelukast group vs 54 exacerbations in the placebo group (p = 0.57). Time to first exacerbation was not different. Number of unscheduled visits and need to start inhaled steroids were comparable in the two groups. Treatment with montelukast after hospital admission for RSV bronchiolitis in children younger than 2 years of age did not reduce symptoms of cough and wheeze. We cannot exclude that a subgroup of children may, however, benefit from this treatment.

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