Montelukast does not prevent reactive airway disease in young children hospitalized for RSV bronchiolitis

Aim: To evaluate the long‐term effect of montelukast on symptoms of cough and wheeze following RSV bronchiolitis. Methods: Fifty eight patients (aged ≤ 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). Results: 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. Conclusion: 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.