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.
Trial registration number clinical trials.gov—NCT00731822.
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To cite: Lötvall J, Bakke PS, Bjermer L, et al. 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. BMJ Open 2012;2:e000370. doi:10.1136/bmjopen-2011-000370
Funding This study was funded by GlaxoSmithKline, study number HZC111348.
Competing interests JL has served as a consultant to and received lecture fees from AstraZeneca, GlaxoSmithKline, Merck Sharpe and Dohme, Novartis and UCB Pharma; has been partly covered by some of these companies to attend previous scientific meetings including the ERS (European Respiratory Society annual congress) and the AAAAI (American Academy of Allergy Asthma and Immunology annual meeting); and has participated in clinical research studies sponsored by AstraZeneca, GlaxoSmithKline, Merck Sharpe and Dohme, and Novartis. PSB has received lecture fees from AstraZeneca, GlaxoSmithKline and NycoMed; has participated in clinical research studies sponsored by GlaxoSmithKline, Pfizer and Boehringer Ingelheim; and is currently member of the Steering Committee and the Scientific Committee of the ECLIPSE study, which is sponsored by GlaxoSmithKline. LB has served as a consultant to and received lecture fees from AstraZeneca, GlaxoSmithKline, Merck Sharpe and Dohme, Novartis and UCB Pharma; has been partly covered by some of these companies to attend previous scientific meetings including the ERS and the AAAAI; and has participated in clinical research studies sponsored by AstraZeneca, GlaxoSmithKline, Merck Sharpe and Dohme, and Novartis. SS has been sponsored by AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim/Pfizer to attend meetings and congresses including ATS (American Thoracic Society annual meeting) and ERS; has participated in clinical research studies sponsored by AstraZeneca, GlaxoSmithKline and Boehringer Ingelheim; and has received lecture fees from GlaxoSmithKline and Boehringer Ingelheim. CS-W, CC, LS, BH are employees of and hold stock in GlaxoSmithKline.
Ethics approval Ethics approval was provided by institutional review board.
Contributors All authors developed the design and concept of the study, had full access to and interpreted the data, and wrote the manuscript. LS, CS-W, BH and CC approved the statistical plan. CS-W coordinated data gathering. LS led the statistical analysis. All authors vouch for the accuracy and completeness of the data and the data analysis. The independent steering committee (JL, PSB, LB and SS) together with the authors employed by the sponsor (CS-W, CC, LS and BH) had full access to the data and were responsible for the decision to publish the paper. Employees of the sponsor performed the statistical analysis, led by LS. The sponsor did not place any restriction on authors about the statements made in the final paper.
Provenance and peer review Not commissioned; externally peer reviewed.
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