TY - JOUR
T1 - Efficacy and safety of fluticasone furoate/vilanterol compared with fluticasone propionate/salmeterol combination in adult and adolescent patients with persistent asthma
T2 - A randomized trial
AU - Woodcock, Ashley
AU - Bleecker, Eugene R.
AU - Lötvall, Jan
AU - O'Byrne, Paul M.
AU - Bateman, Eric D.
AU - Medley, Hilary
AU - Ellsworth, Anna
AU - Jacques, Loretta
AU - Busse, William W.
N1 - Funding Information:
Funding/Support: This study was funded by GlaxoSmithKline [HZA113091].
Funding Information:
Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts of interest: Dr Woodcock has served as consultant to Almirall SA, Chiesi Farmaceutici SpA, Cytos Biotechnology AG, and GlaxoSmithKline and has received lecture fees and research grants from GlaxoSmithKline. Dr Bleecker has served as a consultant to AstraZeneca, Boehringer Ingelheim GmbH, GlaxoSmithKline, Johnson & Johnson, and Merck Sharp & Dohme Corp. He has received reimbursement for travel from GlaxoSmithKline and has performed clinical trials for AstraZeneca; Boehringer Ingelheim GmbH; Cephalon; Forest Laboratories, Inc; Genentech, Inc; GlaxoSmithKline; Kalabios; MedImmune; Novartis Corporation; and Sanofi-Aventis, which have been administered by his employer, Wake Forest School of Medicine. Dr Lötvall has served as a consultant to and received lecture fees from AstraZeneca; GlaxoSmithKline; Merck Sharp and Dohme Corp; Novartis Corporation; and UCB, Inc. He has been partly covered by some of these companies to attend previous scientific meetings, including those of the European Respiratory Society and the American Academy of Allergy, Asthma & Immunology; has provided expert testimony for Barr Pharmaceuticals, Inc; and has participated in clinical research studies sponsored by AstraZeneca, GlaxoSmithKline, Merck Sharp & Dohme Corp, and Novartis Corporation. Dr O'Byrne has served as a consultant to Almirall SA, AstraZeneca, Boehringer Ingelheim GmbH, GlaxoSmithKline, and Merck Sharp & Dohme Corp. He has served on advisory boards for AIM Pharmaceuticals; Altair Therapeutics; Boehringer Ingleheim GmbH; GlaxoSmithKline; MedImmune, LLC; and Merck Sharp & Dohme Corp; has received lecture fees from Chiesi Farmaceutici SpA; and has received research funding from Amgen Inc; AstraZeneca; Asmacure Ltée; Genentech, Inc; and Ono Pharmaceutical Co, Ltd. Dr Bateman has served as a consultant to ALK, Almirall SA, Boehringer Ingelheim, Cephalon Inc, Hoffmann-La Roche Inc, ICON plc, and MS Consulting Group. He has been on advisory boards for Almirall SA; AstraZeneca; Boehringer Ingelheim GmbH; Elevation Pharmaceuticals Inc; Forest Laboratories, Inc; GlaxoSmithKline; Merck Sharp & Dohme Corp; NAPP Pharmaceuticals Limited; Novartis Corporation; and Nycomed. Dr Bateman has also received lecture fees from ALK; AstraZeneca; Boehringer Ingelheim GmbH; Chiesi Farmaceutici SpA; GlaxoSmithKline; Novartis Corporation; Pfizer, Inc Takeda Pharmaceuticals International GmbH and Teva, and his institution has received remuneration for participation in clinical trials sponsored by Actelion Pharmaceuticals US, Inc; Aeras; Almirall SA; AstraZeneca; Boehringer Ingelheim GmbH; Forest Laboratories, Inc; GlaxoSmithKline; Hoffmann-La Roche Inc; Merck Sharp & Dohme Corp; Novartis Corporation; Takeda Pharmaceuticals International GmbH; and Teva Pharmaceutical Industries Ltd. Dr Busse has served as a consultant to Amgen Inc; AstraZeneca; Boehringer Ingelheim GmbH; Genentech, Inc; GlaxoSmithKline; MedImmune, LLC; Novartis Corporation; and Teva Pharmaceutical Industries Ltd. He has served on advisory boards for Altair Therapeutics; Amgen Inc; Centocor Ortho Biotech, Inc; GlaxoSmithKline; Johnson & Johnson Services, Inc; Merck Sharp & Dohme Corp; and Pfizer, Inc. Dr Busse has also received lecture fees from Merck Sharp & Dohme Corp and research funding from AstraZeneca; Ception Therapeutics; GlaxoSmithKline; MedImmune, LLC; and Novartis Corporation. Mss Medley and Ellsworth and Dr Jacques are employees of and hold stock in GlaxoSmithKline.
PY - 2013/10
Y1 - 2013/10
N2 - Background: The combination of fluticasone furoate (FF), a novel inhaled corticosteroid (ICS), and vilanterol (VI), a long-acting β2 agonist, is under development as a once-daily treatment of asthma and COPD. The aim of this study was to compare the efficacy of FF/VI with fluticasone propionate (FP)/salmeterol (SAL) in patients with persistent asthma uncontrolled on a medium dose of ICS. Methods: In a randomized, double-blind, double-dummy, parallel group study, 806 patients received FF/VI (100/25 μg, n = 403) once daily in the evening delivered through ELLIPTA (GlaxoSmithKline) dry powder inhaler, or FP/SAL (250/50 μg, n = 403) bid through DISKUS/ACCUHALER (GlaxoSmithKline). The primary efficacy measure was 0- to 24-h serial weighted mean (wm) FEV 1 after 24 weeks of treatment. Results: Improvements from baseline in 0- to 24-h wmFEV 1 were observed with both FF/VI (341 mL) and FP/SAL (377 mL); the adjusted mean treatment difference was not statistically significant (-37 mL; 95% CI, -88 to 15, P = 0.162). There were no differences between 0- to 4-h serial wmFEV1, trough FEV1, and asthma control and quality-of-life questionnaire scores. There was no difference in reported exacerbations between treatments. Both treatments were well tolerated, with no clinically relevant effect on urinary cortisol excretion or vital signs and no treatment-related serious adverse events. Conclusions: The efficacy of once-daily FF/VI was similar to bid FP/SAL in improving lung function in patients with persistent asthma. No safety issues were identified.
AB - Background: The combination of fluticasone furoate (FF), a novel inhaled corticosteroid (ICS), and vilanterol (VI), a long-acting β2 agonist, is under development as a once-daily treatment of asthma and COPD. The aim of this study was to compare the efficacy of FF/VI with fluticasone propionate (FP)/salmeterol (SAL) in patients with persistent asthma uncontrolled on a medium dose of ICS. Methods: In a randomized, double-blind, double-dummy, parallel group study, 806 patients received FF/VI (100/25 μg, n = 403) once daily in the evening delivered through ELLIPTA (GlaxoSmithKline) dry powder inhaler, or FP/SAL (250/50 μg, n = 403) bid through DISKUS/ACCUHALER (GlaxoSmithKline). The primary efficacy measure was 0- to 24-h serial weighted mean (wm) FEV 1 after 24 weeks of treatment. Results: Improvements from baseline in 0- to 24-h wmFEV 1 were observed with both FF/VI (341 mL) and FP/SAL (377 mL); the adjusted mean treatment difference was not statistically significant (-37 mL; 95% CI, -88 to 15, P = 0.162). There were no differences between 0- to 4-h serial wmFEV1, trough FEV1, and asthma control and quality-of-life questionnaire scores. There was no difference in reported exacerbations between treatments. Both treatments were well tolerated, with no clinically relevant effect on urinary cortisol excretion or vital signs and no treatment-related serious adverse events. Conclusions: The efficacy of once-daily FF/VI was similar to bid FP/SAL in improving lung function in patients with persistent asthma. No safety issues were identified.
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U2 - 10.1378/chest.13-0178
DO - 10.1378/chest.13-0178
M3 - Article
AN - SCOPUS:84885152829
VL - 144
SP - 1222
EP - 1229
JO - Diseases of the chest
JF - Diseases of the chest
SN - 0012-3692
IS - 4
ER -