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

Flow diagram shows study progression.

Kaplan-Meier survival curve reflects asthma stability based on predefined criteria for worsening asthma at 12-week endpoint.

Mean change from baseline in AM PEF. Patients treated with FP100/salmeterol had 36.7 ± 3.7 L/min and 45.2 ± 5.9 L/min improvements from baseline in morning PEF at the 12- and 24-week endpoints, respectively, compared with 18.5 ± 3.6 L/min and 32.5 ± 6.8 L/min, respectively, in patients treated with FP250 (P < .0001, week 12 endpoint). Baseline AM PEF values were 458.0 L/min for FP100/salmeterol and 457.4 L/min for FP250. Patients treated with FP100/salmeterol had 36.8 ± 3.7 L/min and 49.4 ± 5.9 L/min improvements from baseline in evening PEF at the 12- and 24-week endpoints, respectively compared with 20.9 ± 3.7 L/min and 31.3 ± 6.2 L/min in patients treated with FP250 (P = .001, weeks 1-12; P = .039, weeks 1-24).

Reduction in albuterol use from baseline. At the 12-week endpoint, treatment with FP100/salmeterol resulted in a 0.30 ± 0.07 puffs/24 hours reduction in supplemental albuterol compared with a 0.18 ± 0.06 puffs/24 hours reduction after treatment with FP250 (P = .045). At the 24-week endpoint, treatment with FP100/salmeterol resulted in a 0.43 ± 0.11 puffs/24 hours reduction in supplemental albuterol use compared with 0.21 ± 0.07 puffs/24 hours reduction after treatment with FP250 (P = .022).