OBJECTIVE： To observe clinical efficacy and safety of ketotifen fumarate combined with montelukast sodium in the treatment of pediatric cough variant asthma （CVA）. METHODS： 110 children with CVA were selected and divided into observation group and control group according to therapy plan， with 55 cases in each group. Control group was given Montelukast sodium tablet 5 mg， qd； observation group was additionally given Ketotifen fumarate tablet 1 mg， bid. Both group received treatment for 3 months. Clinical efficacies of 2 groups were observed as well as cough symptom scores， lung function index before and after treatment. The occurrence of ADR was compared. RESULTS： The total effective rate of observation group was 92.73％， which was significantly higher than 76.36％ of control group， with statistical significance （P＜0.05）. Before treatment， there was no statistical significance in daytime and nighttime cough symptom scores， lung function index （P＞0.05）. After treatment， daytime and nighttime cough symptom scores， lung function index of 2 groups were improved significantly， and the observation group was significantly better than the control group， with statistical significance （P＜0.05）. There was no statistical significance in the incidence of ADR between 2 groups （P＞0.05）. CONCLUSIONS： Ketotifen fumarate combined with montelukast sodium is better than montelukast sodium in the treatment of pediatric CVA， can effectively improve cough symptom and lung function symptom and don’t increase the occurrence of ADR.