title: Efficacy and safety of fluticasone furoate/vilanterol compared with fluticasone propionate/salmeterol combination in adult and adolescent patients with persistent asthma: a randomized trial.
abstract: 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) FEV1 after 24 weeks of treatment.
  
  
  RESULTS
  Improvements from baseline in 0- to 24-h wmFEV1 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.
authors.affiliation: Institute of Inflammation and Repair, University of Manchester, University Hospital of South Manchester, Manchester, England. Electronic address: Ashley.woodcock@manchester.ac.uk.
authors.forename: Ashley
authors.initials: A
authors.lastname: Woodcock
authors.affiliation: Center for Genomics and Personalized Medicine, Wake Forest School of Medicine, Winston-Salem, NC.
authors.forename: Eugene R
authors.initials: ER
authors.lastname: Bleecker
authors.affiliation: Krefting Research Centre, University of Gothenburg, Gothenburg, Sweden.
authors.forename: Jan
authors.initials: J
authors.lastname: Lötvall
authors.affiliation: Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.
authors.forename: Paul M
authors.initials: PM
authors.lastname: O'Byrne
authors.affiliation: Department of Medicine, University of Cape Town, Cape Town, South Africa.
authors.forename: Eric D
authors.initials: ED
authors.lastname: Bateman
authors.affiliation: Respiratory Medicines Development Centre, GlaxoSmithKline, London, England.
authors.forename: Hilary
authors.initials: H
authors.lastname: Medley
authors.affiliation: Quantitative Sciences Division, GlaxoSmithKline, Research Triangle Park, NC.
authors.forename: Anna
authors.initials: A
authors.lastname: Ellsworth
authors.affiliation: Respiratory Medicines Development Centre, GlaxoSmithKline, London, England.
authors.forename: Loretta
authors.initials: L
authors.lastname: Jacques
authors.affiliation: Department of Medicine, University of Wisconsin-Madison, Madison, WI.
authors.forename: William W
authors.initials: WW
authors.lastname: Busse
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000420:Albuterol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D001592:Benzyl Alcohols / Q000008:administration & dosage*; D002648:Child; D002722:Chlorobenzenes / Q000008:administration & dosage*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D000730:Androstadienes; D001592:Benzyl Alcohols; D002722:Chlorobenzenes; D004338:Drug Combinations; D000068297:Fluticasone-Salmeterol Drug Combination; C550468:vilanterol; C523187:fluticasone furoate; D000420:Albuterol