Comparison of Salmeterol/Fluticasone Propionate Combination with Budesonide in Patients with Mild-to-Moderate Asthma

Abstract

To compare the efficacy and tolerability of a salmeterol/fluticasone propionate (FP) combination product (50/100μg twice daily) with budesonide (BUD) at a four-fold higher microgram dose (400μg twice daily) in patients with mild-to-moderate asthma uncontrolled on existing therapy. This was a multicentre, randomised, double-blind, double-dummy, parallel-group study consisting of a 2-week run-in and a 12-week treatment period. Symptomatic patients (n = 349) received either the salmeterol/FPcombination (50/100μg twice daily; Diskus™) or BUD (400μg twice daily; Turbuhaler™). The salmeterol/FP combination group showed a significantly greater increase in mean morning (p = 0.022) and evening (p = 0.008) peak expiratory flow (PEF) compared with the BUD group. After 12 weeks of treatment, patients in the combination group had a mean PEF of 426 L/min (am) and 435 L/min (pm) compared with 415 L/min (am) and 424 L/min (pm) in the BUD group. The significant benefit of the combination product was evident from day one for both morning (p < 0.001) and evening (p = 0.002) PEF. Both treatments were well tolerated, and no difference was observed between the groups in improved symptom scores, use of rescue medication, clinic spirometry and exacerbations. This study showed that the salmeterol/FP combination product was at least as effective as a four-fold higher microgram dose of BUD, with greater, and more rapid, improvement in morning and evening PEF. Therefore, in patients with mild-to-moderate asthma, symptomatic on existing therapy, the salmeterol/FP combination is an effective alternative to increasing the dose of inhaled corticosteroids, without the need for an additional inhaler.