Objective: To test whether montelukast for preschool children with recurrent wheeze prevents occurence of severe asthma-like symptoms
Methods: A randomized, open-label study was performed in atopic children, 1 to 5 years old, with recurrent, beta2 agonist-responsive wheeze. The patients were eligible if frequency of the symptoms was more than once a month and less than once a week, mild severity, without any asthma controllers. The subjects were randomized to receive daily montelukast (MK) or no controller medication (NC) for 48 weeks. Primary outcome was number of unscheduled visits due to predefined severe asthma-like symptoms; severe wheeze with dyspnea and hypoxemia of SpO2<92% that required systemic steroids or hospitalization.
Results: Ninety-three children were enrolled. Forty seven patients were assigned to MK and 46 to NC. The number of the exacerbation episodes was significantly lower in MK group than in NC group, 0.9 and 1.9 times/year, respectively. The duration until the first exacerbation was significantly longer in MK group than NC group. The odds ratio for the exacerbation was 0.54 (95% CI: 0.34 – 0.87) with the treatment.
Conclusions: Montelukast may prevent progression of the disease from mild to more severe phenotype in preschool-age children with recurrent wheeze.