Efficacy and safety of 4 weeks' treatment with combined fluticasone furoate/vilanterol in a single inhaler given once daily in COPD: A placebo-controlled randomised trial

This multicenter, randomized, double-blind, parallel-group study investigated the efficacy and safety of once-daily fluticasone furoate/vilanterol versus placebo in 60 patients with COPD. The co-primary endpoints were the change from baseline in supine weighted mean heart rate at 0–4 hours post-dose and the incidence of adverse events; secondary endpoints were change from baseline in trough clinic visit FEV1 (23–24 hours post-dose) and weighted mean FEV1 (0–4 hours post-dose). FEV1 was measured in the clinic using a Vitalograph COMPACT Medical Workstation.