@article{45b8584f06df46c0884c9002495e2971,
title = "Fluticasone Furoate-Vilanterol 100-25 mcg Compared with Fluticasone Furoate 100 mcg in Asthma: A Randomized Trial",
abstract = "Background: The inhaled corticosteroid fluticasone furoate (FF) in combination with the long-acting β2-agonist vilanterol (VI) is under development for the treatment of asthma and chronic obstructive pulmonary disease. Objective: To compare the efficacy and safety of FF-VI and FF in patients (≥12 years old) with persistent asthma. Methods: In a randomized, double-blind, parallel-group study, patients (n = 609) (intent-to-treat population) received FF-VI 100-25 mcg, FF 100 mcg, or placebo once daily (evening) by using a dry powder inhaler for 12 weeks. Coprimary end points were change from baseline in trough FEV1 and serial (0-24 hours) weighted mean FEV1 (wmFEV1). Rescue-free 24-hour periods and safety also were assessed. Results: Placebo increased trough FEV1 (196 mL) and wmFEV1 (212 mL) versus baseline. Compared with placebo, FF-VI and FF significantly improved trough FEV1 (172 mL [P < .001] and 136mL [P= .002]), respectively, and serial wmFEV1 (302 mL [P < .001] and 186 mL [P= .003]), respectively. Treatment differences between FF-VI and FF approached significance for serial wmFEV1 (116 mL; P= .060) but not for trough FEV1 (36 mL; P= .405). The percentage of rescue-free 24-hour periods with FF-VI was 10.6% greater than FF and 19.3% greater than placebo. Statistically significant (P= .032) urinary cortisol suppression was observed with FF-VI (ratio, 0.82) relative to placebo, but not with FF. Adverse event and safety profiles were similar across treatment groups. Conclusions: Significant improvement in lung function was observed with FF-VI and FF versus placebo in patients with persistent asthma. Improvement of FEV1 when VI was added to FF was not significant. The high placebo response in evening trough FEV1 may have influenced the assessment of efficacy.",
keywords = "Asthma, Efficacy, Fluticasone furoate, Randomized trial, Safety, Tolerability, Vilanterol",
author = "Bleecker, {Eugene R.} and Jan L{\"o}tvall and O'Byrne, {Paul M.} and Ashley Woodcock and Busse, {William W.} and Kerwin, {Edward M.} and Richard Forth and Medley, {Hilary V.} and Carol Nunn and Loretta Jacques and Bateman, {Eric D.}",
note = "Funding Information: Conflicts of interest: E. R. Bleecker has received research support, consulting fees, travel support, and fees for participating in review activities from GlaxoSmithKline; has received research support from AstraZeneca , Boehringer-Ingelheim , Cephalon , Forest , Genentech , GlaxoSmithKline , KalaBios , MedImmune , Novartis , Sanofi-Aventis ; and consultancy fees from AstraZeneca, Boehringer-Ingelheim, Genentech, GlaxoSmithKline, Johnson & Johnson, Merck. J. L{\"o}tvall has received consultancy fees from Novartis, Merck, GlaxoSmithKlie, and AstraZeneca; has provided expert testimony for Barr Pharmaceuticals; has received research support from AstraZeneca, GlaxoSmithKline, Novartis, and Merck; has received lecture fees from AstraZeneca, Novartis, and GlaxoSmithKline; has a 65% ownership patent on using exosomes for transfer of nucleotides; and is coeditor-in-chief of Biomedcentral Respiratory Research since 2004. P. M. O'Byrne has received consulting fees and fees for participating in the study supervisory committee from GlaxoSmithKline; has received consultancy fees from Almiral, AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, and Merck; has received research support from Amgen, Asmacure, AstraZeneca, Genentech, and Ono; and has received lecture fees from Chiesi. A. Woodcock has received consultancy fees from Chiese, GlaxoSmithKline, Almirall, and Cytos; has received lecture fees from GlaxoSmithKline. W. W. Busse is on the Merck Board; has received consultancy fees from Amgen, AstraZeneca, Novartis, GlaxoSmithKline, MedImmune, and Genentech; has received research support from the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases and NIH–National Heart, Lung, and Blood Institute; and receives royalties from Elsevier. E. M. Kerwin has conducted more than 70 pharmaceutical clinical trials through the Clinical Research Institute of Southern Oregon, PC, including trials for GlaxoSmithKline; has served on AstraZeneca, Ironwood, Mylan, Pearl, Sanofi Aventis, Sunovion, and Targacept advisory boards; has received lecture fees from AstraZeneca, Pfizer, Sanofi Aventis, and Sunovion; has received travel support from Merck, Forest, and Novartis. R. Forth, H. V. Medley, C. Nunn, and L. Jacques are employees of and hold stock in GlaxoSmithKline. E. D. Bateman has received research support, consulting fees, travel support, and fees for reviewing the results from GlaxoSmithKline; is on the Boehringer Ingelheim Asthma and Respiratory Board; the AstraZeneca Overall Asthma Control Board; the Elevation Pharma Chronic Obstructive Pulmonary Disease (COPD) Drug Development Board; the Napp Pharmaceuticals Trial Design Board; the Novartis, Almirall, and Forest Drug Development COPD Boards; the Merck and GlaxoSmithKline Asthma Treatments Boards; and the Nycomed Roflumilast Development Board; has received consultancy fees from Navigant Consulting, IMS Consulting Group, Alk Abello, Almirall, Hoffmann la Roche, Cephalon, and ICON; has received research support from Actelion, Aeras, Almirall, AstraZeneca, Boehringer Ingelheim, Forest, GlaxoSmithKline, Hoffman La Roche, Merck, Novartis, Takeda, and Teva; has received lecture fees from AstraZeneca, ALK Abello, Chiese, Boehringer Ingelheim, GlaxoSmithKline, Takeda, Novartis, and Pfizer; has received payment for the development of educational presentations from Indegene Lifesciences; is on the Board of the Global Initiative for Asthma; and is on the American Thoracic Society/European Respiratory Society Task Force on Severe Asthma. Funding Information: This study was funded by GlaxoSmithKline ( GSK HZA106827 ; www.clinicaltrials.gov registration number NCT01165138 ). Editorial support in the form of development of a draft outline in consultation with the authors, development of a manuscript first draft in consultation with the authors, editorial suggestions to draft versions of this article, assembling tables and figures, collating author comments, copyediting, fact checking, referencing, and graphic services was provided by Lisa Moore, PhD, and David Cutler, PhD, at Gardiner-Caldwell Communications (Macclesfield, UK), and was funded by GlaxoSmithKline. Publisher Copyright: {\textcopyright} 2014 American Academy of Allergy, Asthma & Immunology.",
year = "2014",
doi = "10.1016/j.jaip.2014.02.010",
language = "English (US)",
volume = "2",
pages = "553--561",
journal = "Journal of Allergy and Clinical Immunology: In Practice",
issn = "2213-2198",
publisher = "American Academy of Allergy, Asthma and Immunology",
number = "5",
}