OBJECTIVE： To investigate clinical efficacy and safety of montelukast combined with budesonide in the treatment of bronchial asthma （BA）， and it effects on clinical symptom， inflammatory factor and immune function of BA children. METHODS： Totally 106 BA children selected from pediatrics department of our hospital during Jan. 2014-Dec. 2015 were divided into observation group and control group according to  random number table， with 53 cases in each group. Based on routine treatment， control group was given Budesonide suspension for inhalation 400 μg， bid. Observation group was additionally given Montelukast sodium tablets orally， 4 mg for under 5 years old， qd， 5 mg for 5 years old or older， qd， on the basis of control group. Treatment courses of 2 groups lasted for 8 weeks. Clinical efficacies of 2 groups were compared as well as clinical symptom scores， inflammatory factor and immune factor levels before and after treatment. The occurrence of ADR was also compared between 2 groups. RESULTS： The total response rate of observation group （94.34％） was significantly higher than that of control group （77.36％）； the symptom relief time and lung signs disappearance time were significantly shorter than control group， with statistical significance （P＜0.05）. Before treatment， there was no statistical significance in clinical symptom scores， inflammatory factor and immune factor levels between 2 groups （P＞0.05）. After treatment， daytime and nighttime symptom scores， the levels of IL-6， IL-8， TNF-α and IgE in 2 groups were significantly decreased， while the levels of IgA and IgG were increased significantly； the observation group was significantly better than control group， with statistical significance （P＜0.05）. There was no statistical significance in the incidence of ADR between 2 groups （5.66％ vs. 7.55％） （P＜0.05）. CONCLUSIONS：  Montelukast combined with budesonide help to reduce the level of serum inflammatory cytokines in BA children， improve immune function and clinical symptoms with good safety.