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• W2116744855 abstract "<h3>Background</h3> Fluticasone furoate/vilanterol (FF/VI) is a novel once-daily (OD) inhaled corticosteroid/long-acting β₂ agonist combination in development for chronic obstructive pulmonary disease (COPD) and asthma. <h3>Trial design</h3> A multicentre, randomised, double-blind, parallel-group, placebo-controlled study. <h3>Methods</h3> Participants were patients with moderate-to-severe COPD treated with placebo or FF/VI 400/25 μg OD for 4 weeks. Study objectives were to assess the safety and efficacy of FF/VI 400/25 μg OD administered for 4 weeks via a novel dry powder inhaler. Co-primary end points were change from baseline in weighted mean (wm) heart rate 0–4 h postdose at day 28 and the incidence of adverse events (AEs). Secondary end points included change from baseline in trough forced expiratory volume in one second (FEV₁) (23–24 h postdose; day 29) and wm FEV₁ (0–4 h postdose; day 28). Patients were randomised to receive FF/VI 400/25 μg or placebo in a 2:1 ratio; all patients and investigators were blinded to active or placebo treatment. <h3>Results</h3> 60 patients (mean age 64 years) were randomised (FF/VI: n=40; placebo: n=20), and all contributed data to the analysis. Mean screening post-bronchodilator FEV₁ per cent predicted was comparable between groups (FF/VI: 58.5%; placebo: 60.1%). The wm heart rate 0–4 h postdose was similar between groups (difference: 0.6 beats per minute; 95% CI −3.9 to 5.1). More on-treatment AEs were reported in the FF/VI group (68%) compared with the placebo group (50%). The most common drug-related AEs in the FF/VI group were oral candidiasis (8%) and dysphonia (5%). There were no clinically relevant effects on laboratory values, including glucose and potassium, or on vital signs or ECGs/Holters. The FF/VI group had statistically greater improvements compared with placebo in trough FEV₁ (mean difference 183 ml) and 0–4 h postdose wm FEV₁ (mean difference 236 ml). <h3>Conclusion</h3> FF/VI has a good safety and tolerability profile and improves lung function compared with placebo in patients with COPD. <h3>Trial registration number</h3> clinical trials.gov—NCT00731822." @default.
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• W2116744855 date "2012-01-01" @default.
• W2116744855 modified "2023-10-18" @default.
• W2116744855 title "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" @default.
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• W2116744855 doi "https://doi.org/10.1136/bmjopen-2011-000370" @default.
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