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To compare the efficacy and safety of the inhaled corticosteroid fluticasone propionate (FP) and the inhaled long-acting β₂-agonist salmeterol (SM), when administered together in a single device (Diskus; GlaxoSmithKline, Inc; Research Triangle Park, NC), with that of placebo and the individual agents alone in patients with COPD.

Randomized, double-blind, multicenter, placebo-controlled study.

Seventy-six investigative sites in the United States.

Seven hundred twenty-three patients ≥ 40 years of age with COPD and a mean baseline FEV₁ of 42% predicted.

FP (250 μg), SM (50 μg), FP plus SM combined in a single inhaler (FSC), or placebo administered twice daily through the Diskus device for 24 weeks.

Primary efficacy measures were morning predose (ie, trough FEV₁) for FSC compared with SM and 2-h postdose FEV₁ for FSC compared with FP …