The salmeterol/fluticasone combination is more effective than fluticasone plus oral montelukast in asthma

AbstractThe aim of this study was to compare the efficacy and safety of salmeterol/fluticasone propionate combination product (SFC) with fluticasone propionate (FP) plus oral montelukast (M) over 12 weeks in symptomatic asthma patients. The study was a multinational, randomised, double-blind, double-dummy, parallel-group design in patients aged ≥15 years. After a 4-week run-in during which all patients received FP 100 μg twice daily, patients were randomised to inhaled SFC (50/100 μg) twice daily or inhaled FP 100 μg twice daily and oral M 10 mg once daily. Patients kept daily records of their peak expiratory flow (PEF), symptom scores and use of rescue medication. Over the 12-week treatment period, the adjusted increase in mean morning PEF was significantly greater in the SFC group (36 l/min) than the FP/M group (19 l/min;P <0.001). The improvement in FEV1 was also significantly greater in the SFC group (mean treatment difference 0.11 l; P