Anti-leukotriene compared to inhaled corticosteroid for recurrent wheezing in children under five years of age: A randomized clinical trial

Introduction: Asthma is the common chronic disease in childhood. One of the major symptoms of asthma in children is wheezing. According to the international guidelines, inhaled corticosteroid (ICS) is prescribed for treating recurrent wheezing in children less than five years. However, due to poor adherence, high cost, and possible side effects of ICS in young children, anti-leukotrienes are recommended as a safe initial treatment for recurrent wheezing. Therefore, we performed this study to compare anti-leukotriene versus ICS in treating recurrent wheezing in children less than five years. Methods: We enrolled 68 patients less than five years old with recurrent wheezing (more than three times over the past year) and mild persistent asthma in this randomized controlled clinical trial. The patients were randomly divided in a 1:1 ratio into two groups. Group 1 was treated by ICS 50 mcg twice daily and group 2 was received montelukast 4 mg granules daily. The patients followed up for six months and the results of the two groups were compared. Results: Thirty-four of 68 patients received montelukast and 34 patients received ICS. In montelukast and ICS group, 23 (68%) and 20 (59%) patients were boys, respectively. The frequency of wheezing decreased significantly in patients receiving montelukast (P<0.001) as well as ICS (P<0.001). However, there were no differences between two groups in the efficacy of treatment (P=0.38). Conclusion: In children less than five years with mild persistent asthma, both montelukast and ICS were effective with no differences between groups in the efficacy of treatment.