Salmeterol/fluticasone propionate combination therapy 50/250 μg twice daily is more effective than budesonide 800 μg twice daily in treating moderate to severe asthma

Three hundred and fifty-three asthmatic patients who remained symptomatic despite treatment with budesonide 800-1200 mu g day(-1) (or equivalent) were randomized to a new combination therapy comprising salmeterol 50 mu g and fluticasone propionate 250 mu g (Seretide(TM), Advair(TM), Viani(TM) 50/250 mu g) twice daily or budesonide 800 mu g twice daily for 24 weeks. Patients kept daily records of their morning and evening peak expiratory flow (PEF), daytime and night-time symptom scores and daytime and night-time use of rescue salbutamol. Mean morning PEF increased by 451 min(-1) (baseline 3611 min(-1)) in the salmeterol/fluticasone propionate combination (SFC) group and by 191 min(-1) (baseline 3581 min(-1)) in the budesonide group over the 24 weeks. The adjusted mean morning PEF over weeks 1 to 24 was significantly greater in the SFC group, despite the > three-fold lower corticosteroid dose (406 vs. 3801 min(-1); P < 0.001). A significantly greater improvement in evening PEF was also seen in the SFC group (adjusted mean 416 vs. 3981 min(-1); P < 0.001). SFC also provided significantly better control of daytime symptoms and a significantly greater reduction in the requirement for rescue salbutamol compared with budesonide. These results demonstrate that SFC 50/250 mu g twice daily is superior to budesonide 800 mu g twice daily in the management of patients with moderate to severe asthma who are symptomatic on their existing dose of corticosteroid.