Steroid-sparing effects of fluticasone propionate 100 μg and salmeterol 50 μg administered twice daily in a single product in patients previously controlled with fluticasone propionate 250 μg administered twice daily

Background: Concurrent use of an inhaled corticosteroid (ICS) and an inhaled long-acting beta(2)-agonist provides better overall asthma control than the use of higher doses of ICS alone. Objective: The purpose of this investigation was to determine whether fluticasone propionate (FP) combined with salmeterol in the Diskus device can be used to reduce the dose of ICS in patients currently stable on medium-dose ICS while maintaining asthma control. Methods: This was a randomized, double-blind, parallel group, 12- to 24-week trial consisting of a 3-part run-in period. The run-in period was designed to first establish FP 250 mug administered twice a day (bid) via Diskus as the minimum effective dose. During run-in period 1, patients received FP 220 mug bid or the equivalent for 10 to 14 days. Controlled patients moved to run-in period 2 (5-28 days), which assessed asthma stability on FP 100 mug bid administered via Diskus. Only patients who became unstable on FP 100 mug bid were eligible to enter run-in period 3 (26-30 days), during which they were placed on FP 250 mug bid and those regaining asthma control were eligible for randomization. The primary efficacy end-point was the proportion of patients who remained in the study with no evidence of worsening asthma. Secondary efficacy measures included FEV1, morning peak expiratory flow, percent of symptom-free days, and daily albuterol use. Results: Only 5% of patients treated with FP 100/salmeterol withdrew because of worsening asthma in the first 12 weeks; this compared with 7% in the FP 250 group. All patients from a subset of sites continued in the study for an additional 12 weeks; only an additional 1% of patients treated with either FP 100/salmeterol or FP 250 withdrew because of worsening asthma. Secondary efficacy measures confirmed primary effiacy results. Conclusion: In patients requiring FP250 bid for asthma stability, FP100/salmeterol bid was steroid-sparing, allowing a 60% reduction in the FP dose while maintaining overall asthma control.