Comparative Efficacy and Safety of Low-Dose Fluticasone Propionate and Montelukast in Children With Persistent Asthma

Abstract

Purpose of the Study. To evaluate efficacy, safety, health outcomes, and cost-effectiveness of fluticasone propionate (FP) versus montelukast in children with asthma Study Population. Children aged 6 to 12 years with persistent asthma. Methods. Multicenter, randomized, double-blind, double-dummy, parallel-group study of 342 children with persistent asthma. Children received either FP 50 μg twice daily via Diskus or montelukast 5 mg once daily for 12 weeks. The primary efficacy variable was percent change in morning predose forced expiratory volume in 1 second at the end point. Results. Compared with montelukast, children treated with FP experienced a significantly greater increase in mean percent forced expiratory volume in 1 second, mean morning peak expiratory flow rate, and mean evening peak expiratory flow rate. Children treated with FP also experienced significantly greater reductions in total supplemental albuterol use, mean nighttime albuterol use, and mean nighttime symptom scores compared with children treated with montelukast. There were no significant differences between the groups for daytime asthma symptom scores, daytime albuterol use, percent symptom-free days, or adverse events. Parent and physician satisfaction ratings were significantly higher for FP treatment. The daily total asthma-related cost per patient in the FP group was approximately one third of the cost in the montelukast group. Conclusions. FP was significantly more effective than montelukast in improving pulmonary function, asthma symptoms, and rescue albuterol use. Both therapies had similar safety profiles. Reviewer Comments. Comparative studies in adults and adolescents have previously shown greater efficacy with inhaled corticosteroids versus leukotriene receptor antagonists. This 12-week study reports similar findings for children 6 to 12 years of age with persistent asthma. Based on efficacy, cost, and safety profiles, low-dose inhaled corticosteroids should be considered first-line therapy in this age group.