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

Abstract

Three hundred and fifty-three asthmatic patients who remained symptomatic despite treatment with budesonide 800–1200 μ g day−1(or equivalent) were randomized to a new combination therapy comprising salmeterol 50 μ g and fluticasone propionate 250 μ g (SeretideTM, AdvairTM, VianiTM50/250 μ g) twice daily or budesonide 800 μ 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 45 l min−1(baseline 361 l min−1) in the salmeterol/fluticasone propionate combination (SFC) group and by 19 l min−1(baseline 358 l 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 (406vs . 380 l min−1;P<0·001). A significantly greater improvement in evening PEF was also seen in the SFC group (adjusted mean 416 vs. 398 l 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 μ g twice daily is superior to budesonide 800 μ g twice daily in the management of patients with moderate to severe asthma who are symptomatic on their existing dose of corticosteroid.