Abstract Background and objectives: Asthma is a major public health problem affecting over millions people worldwide. Intermittent asthma is the most common pattern in children. Asthma exacerbations often occur after viral respiratory infection. Montelukast (a leukotriene receptor antagonist) has a rapid onset of action and may be effective on reduction of asthma exacerbation if that use early onset viral upper respiratory tract infection. Method and materials: A total of 187 children with intermittent asthma aged between 6-12 years with were participated in this multicenter, randomized, double-blind, placebo-controlled clinical trial over 2-month period. The children were divided into two groups as Montelukast(93) and placebo(94). Treatment with Montelukast or placebo was initiated by parents at the onset of viral upper respiratory tract infection and continued for 7 days. Results:. Montelukast significantly decreased the cough by 6% (p=0.006), night time awakenings by 5.4% (p=0.013), whereas there were a non significant reduction in wheezing, thachypnea and respiratory distress.( p=0.801) Conclusion: A short course of Montelukast , introduced at the first sign of an viral URI ,results in a reduction in symptoms such as: cough and nights awakened. Montelukast as an available treatment, has no significant side effect. Further studies are needed with exceeding cases and duration.
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