Abstract

Background and Aims: Leukotrienes are major inflammatory mediators in wheezing-LRI and leukotriene antagonist has been reported to be effective in asthmatic children. This randomized double-blind, placebo-controlled trial study was performed to evaluate the efficacy of montelukast in the treatment of wheezing-LRI and in prevention of recurrent wheezing among previously healthy children under 5 years of age with risk of asthma. Methods: The enrolled patients were randomly allocated into the studied group (receiving 4-mg montelukast once daily while being hospitalized) and the control group (receiving placebo). The 2 groups were compared in terms of clinical severity scores, duration of oxygen use, length of hospital stay, chest X-ray, viral study and urine leukotriene E4 levels. All patients were followed up for 6 months to evaluate their recurrent wheezing episodes and pulmonary function tests. Results: 21 patients (mean age 23 months) were recruited. 11 patients received montelukast, 10 patients received placebo. There were no differences in clinical severity scores, duration of O2 therapy, length of hospital stay and urine leukotriene E4 levels between the two groups. During the 6-month-follow up period, the montelukast group had lower recurrent wheezing episodes and inhaled corticosteroid use but not statistically significant. The airway resistance was significantly decreased after 6 months in the montelukast group (mean of difference = -0.14, p = 0.004). Conclusion: In wheezing-LRI children with risk of asthma, montelukast was ineffective in improving acute outcomes and prevention of recurrent wheezing. However; montelukast might be beneficial in decreasing airway resistance.

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