To evaluate the safety and efficacy of fluticasone propionate/salmeterol 250/50μg once daily in the evening (FSC QD) versus fluticasone propionate 250μg once daily in the evening (FP QD) versus placebo (PLA) in asthma patients who were symptomatic on short-acting beta₂-agonists. All treatments were administered via the Diskus®.

At baseline, patients had a mean FEV₁ of 2.52 L/min and a mean % predicted PM PEF of 77%. Patients were randomized to FSC QD (n=210), FP QD (n=212) or PLA (n=212) for 12-weeks.

Treatment with FSC QD resulted in significant improvements (p<0.001) in the primary efficacy measure, % predicted PM PEF over Weeks 1-12, compared with FP QD, and treatment with FP QD resulted in significant improvements in % predicted PM PEF (p=0.006) compared with PLA. Also, there were significantly greater improvements in all secondary efficacy measures (% predicted AM PEF, 2-hour post-dose PEF on Day 1, 24-hour albuterol use, and 24-hour asthma symptoms), for FSC versus FP (p≤0.041) except for symptom scores (p=0.076). Likewise, there were significantly greater improvements in all secondary efficacy measures for FP versus PLA (p≤0.001) except, as expected, for 2-hour post-dose PEF. Drug-related adverse events were low (range 4-9%) and similar across treatment groups. Twenty-four hour urinary cortisol excretion was also similar across treatment groups.

Treatment with FSC was effective as a QD regimen and FSC QD was superior to FP QD in improving overall asthma control. Likewise, FP QD was superior to PLA in improving overall asthma control. (SAS30022)