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Data from: Efficacy and safety of four weeks’ treatment with combined fluticasone furoate/vilanterol in a single inhaler given once daily in COPD: a placebo-controlled randomised trial

When using this data, please cite the original article:

Lötvall J, Bakke PS, Bjermer L, Steinshamn S, Scott-Wilson C, Crim C, Sanford L, Haumann B (2012) Efficacy and safety of four weeks’ treatment with combined fluticasone furoate/vilanterol in a single inhaler given once daily in COPD: a placebo-controlled randomised trial. BMJ Open 2(1): e000370. doi:10.1136/bmjopen-2011-000370

Additionally, please cite the Dryad data package:

Lötvall J, Bakke PS, Bjermer L, Steinshamn S, Scott-Wilson C, Crim C, Sanford L, Haumann B (2012) Data from: Efficacy and safety of four weeks’ treatment with combined fluticasone furoate/vilanterol in a single inhaler given once daily in COPD: a placebo-controlled randomised trial. Dryad Digital Repository. doi:10.5061/dryad.7p1r30q5
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Dryad Package Identifier doi:10.5061/dryad.7p1r30q5    80 views  
Abstract BACKGROUND: 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. TRIAL DESIGN: A multicentre, randomised, double-blind, parallel-group, placebo-controlled study. METHODS: 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. RESULTS: 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). CONCLUSION: FF/VI has a good safety and tolerability profile and improves lung function compared with placebo in patients with COPD.
Keywords Chronic airways disease, RESPIRATORY MEDICINE, THORACIC MEDICINE,
Date Deposited 2012-01-26T16:43:37Z
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To the extent possible under law, the authors have waived all copyright and related or neighboring rights to this data.  


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