Abstract: OBJECTIVE To explore the effect of domestic montelukast on treatment of acute respiratory tract infection children complicated with cough. METHODS The patients with acute respiratory tract infection who had history of cough were enrolled in the study and randomly divided into the treatment group and the contnol group, with 145 cases in the treatment group, 141 cases in the control group. The two groups of patients were treated within 24 hours of fever. The gender, age and fever time at the treatment were statistically comparable between the two groups of patients. The treatment group was given additional 5mg of domestic montelukast for 21 days, once a day, and other treatment plans were as same as those of the control group. The time, severity and duration (from the onset to the 1st,3rd,5th and 7th day)of cough as well as the duration of cough for more than 4 weeks (28 days) were observed and scored after the treatment, the severity of cough was compared based on the scores; the drug-induced adverse reactions were monitored. RESULTS There was no significant difference in the score of cough on the 1st day between the two groups of patients; there were significant differences in the scores of cough on the 3rd, 5th and 7th day as well as for more than 4 weeks (P<0.01). In the treatment group, there were 51 cases of cough on the 3rd day, 70 cases on the 5th day, 88 cases on the 7th day, 11 cases for more than 4 weeks. In the control group, there were 99 cases of cough on the 3rd day, 110 cases on the 5th day, 128 cases on the 7th day, 28 cases for more than 4 weeks; there were significant differences between the two groups (P<0.01). Totally 5 patients had montelukast-induced adverse reactions in the treatment group, manifesting as headache, excitement and restlessness of sleep, which disappeared after 1 week. CONCLUSION The early application of domestic montelukast may effectively alleviate or reduce the incidence of cough, especially the chronic cough,in the children who have acute respiratory tract infection.