Salmeterol/fluticasone propionate (50/250 μg) combination is superior to double dose fluticasone (500 μg) for the treatment of symptomatic moderate asthma

Questions under study: if patients with asthma remain symptomatic in spite of chronic treatment with inhaled corticosteroids (ICS), increasing the ICS dosage or adding another drug to the treatment regimen are possible therapeutic alternatives. We compared the efficacy and safety of combined salmeterol fluticasone therapy (SFC, 501250 mug twice daily) with twice the dose of fluticasone propionate (FP, 500 mug b.i.d.) in symptomatic asthmatics. Methods: this prospective, double-blind study was conducted in 76 study centres. 365 symptomatic patients with moderate asthma aged >18 years and receiving ICS in a dose equivalent to 1,000 mug beclomethasone propionate per day were randomly assigned to receive either salmeterol xinafoate (50 mug) and fluticasone propionate (250 mug) in a single dry powder inhaler (Diskus(R)) or 500 mug FP twice daily. The primary efficacy endpoint was morning peak expiratory flow rate (PEFR). Secondary measurements included forced expiratory volume in 1 second (FEV1), asthma symptom scores, and use of rescue medication. Results: combined salmeterol fluticasone therapy resulted in significantly greater improvements in PEFR and symptom control than doubling the dose of FP. At week 12, morning PEFR had increased by 52 L/min from baseline in patients on SFC and by 36 L/min in subjects receiving FR The adjusted difference between groups was 16.6 L/min (95% confidence interval, 1.1 to 32.0 L/min). In the SFC group, the percentage of symptom-free days increased from baseline by 49% of days as compared with 38% of days after FP (adjusted difference: 12.6% of days, 95 % Cl 4.0 to 20.7). Quality of life improved to a greater degree after SFC therapy, and patients regarded study drugs as superior to their previous asthma medication. Adverse event profiles were similar between groups. Conclusions: the combination of salmeterol 50 mug and fluticasone 250 mug in a single dry powder inhaler was superior to twice the dose of FP (500 mug). It seems justified to add salmeterol rather than increasing the ICS dose if symptomatic asthmatics require supplementary therapy.