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

ObjectiveTo 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.DesignThis was a multicentre, randomised, double-blind, double-dummy, parallel-group study consisting of a 2-week run-in and a 12-week treatment period.InterventionsSymptomatic patients (n = 349) received either the salmeterol/FPcombination (50/100μg twice daily; Diskus™) or BUD (400μg twice daily; Turbuhaler™).ResultsThe 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.ConclusionsThis 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.