ABSTRACT
BACKGROUND: Although montelukast has an established role in the management of chronic asthma in children, its efficacy in acute asthma exacerbations (AAEs) in children aged 2 to 5 years is not fully known. This study aimed to evaluate the effectiveness and safety of montelukast for treating AAE in children aged 2 to 5 years in China. METHODS: In total, 120 Chinese children with AAE, aged 2 to 5 years, were randomly divided into 2 groups, each with 60 patients. All patients received either montelukast or placebo along with standard therapy for acute asthma between January 2011 and December 2015. The outcome measurements included the difference in peak expiratory flow and lung function improvements, as well as adverse events. RESULTS: A total of 117 patients completed the study. Montelukast showed no greater effectiveness than did placebo in increasing the peak expiratory flow during the period of hospital stay (P = 0.92 at day 2, P = 0.86 at day 3, and P = 0.82 at day 4) and at discharge (P = 0.84). Similarly, the forced expiratory volume in 1 second at discharge also did not show significant difference between the 2 groups (P = 0.80). In addition, no serious adverse events were found during the intervention period of the study. CONCLUSIONS: The results of this study demonstrate no benefit of montelukast over placebo in the treatment of AAE in a cohort of 2- to 5-year-old children.
