Efficacy of oral montelukast in comparison of inhaled steroids for mild persistent asthma among children aged 1-5 years: A randomized clinical trial in Sri-Lanka

Abstract

Background: In Sri Lanka, the incidence of asthma has been reported as 2.6% in children. Increased cost and poor adherence of Inhaled Corticosteroids (ICSs) put forward the advancement of leukotriene antagonists like montelukast. However, the efficacy of montelukast has not been studied fully in children of Sri Lanka. The aim of this study is to compare the efficacy of montelukast and ICS in children aged 1 to 5 years with mild persistent asthma. Methods: This randomized clinical trial was conducted from December 2011 May 2013. Children age 1-5 years having cough and wheeze were included. The endpoint of the study was to determine the effectiveness of montelukast in the improvement of asthma symptoms measured by asthma score in comparison to ICS. Participants were divided into 2 groups where group 1 was designated for ICS and group 2 for montelukast. Data was recorded daily in the symptom diary, while coded and analyzed on SPSS. This trial is registered with Sri Lanka Clinical Trial Registry under number: SLCTR/2011/006. Results: The study population of 81 children of which 64.2% were male, mean age was 40.12 ± 13.50 months and weight of 17.70 ± 21.65 Kg. Significant improvement in the mean asthma score was observed in both groups. As compared to ICS, nasal congestion was significantly reduced in montelukast group with mean score of 281.71 ± 27.05 (p = 0.034) and improvement in physical activities were equally achieved. Conclusion: Montelukast is equally effective as inhaled corticosteroids in prevention of mild persistent asthma among 1-5 years and additional significant benefit in controlling rhinitis. *Correspondence to: Jayawardena PP, Department of Pediatrics, Faculty of Medicine, University of Ruhuna, Karapitiya, Galle, Sri Lanka, Tel: +94 777901662; Fax: +94 91 2222314; E-mail: pushpikaja@yahoo.com.au