title: The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in asthma.
abstract: BACKGROUND
  Novel therapies need to be evaluated in normal clinical practice to allow a true representation of the treatment effectiveness in real-world settings.
  
  
  METHODS
  The Salford Lung Study is a pragmatic randomised controlled trial in adult asthma, evaluating the clinical effectiveness and safety of once-daily fluticasone furoate (100 μg or 200 μg)/vilanterol 25 μg in a novel dry-powder inhaler, versus existing asthma maintenance therapy. The study was initiated before this investigational treatment was licensed and conducted in real-world clinical practice to consider adherence, co-morbidities, polypharmacy, and real-world factors.
  
  
  METHODS
  Asthma Control Test at week 24; safety endpoints include the incidence of serious pneumonias. The study utilises the Salford electronic medical record, which allows near to real-time collection and monitoring of safety data.
  
  
  CONCLUSIONS
  The Salford Lung Study is the world's first pragmatic randomised controlled trial of a pre-licensed medication in asthma. Use of patients' linked electronic health records to collect clinical endpoints offers minimal disruption to patients and investigators, and also ensures patient safety. This highly innovative study will complement standard double-blind randomised controlled trials in order to improve our understanding of the risk/benefit profile of fluticasone furoate/vilanterol in patients with asthma in real-world settings.
  
  
  BACKGROUND
  Clinicaltrials.gov, NCT01706198; 04 October 2012.
authors.affiliation: Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK. ashley.woodcock@manchester.ac.uk.
authors.forename: Ashley
authors.initials: A
authors.lastname: Woodcock
authors.affiliation: Salford Royal NHS Foundation Trust, Salford, UK. nawar.bakerly@srft.nhs.uk.
authors.forename: Nawar Diar
authors.initials: ND
authors.lastname: Bakerly
authors.affiliation: Salford Royal NHS Foundation Trust, Salford, UK. john.new@manchester.ac.uk.
authors.forename: John P
authors.initials: JP
authors.lastname: New
authors.affiliation: Salford Royal NHS Foundation Trust, Salford, UK. Martin.Gibson@manchester.ac.uk.
authors.forename: J Martin
authors.initials: JM
authors.lastname: Gibson
authors.affiliation: GlaxoSmithKline, Research Triangle Park, Durham, NC, USA. wei.w.wu@gsk.com.
authors.forename: Wei
authors.initials: W
authors.lastname: Wu
authors.affiliation: Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK. jorgen.vestbo@manchester.ac.uk.
authors.forename: Jørgen
authors.initials: J
authors.lastname: Vestbo
authors.affiliation: GSK Respiratory Centre of Excellence, GlaxoSmithKline UK Ltd, Uxbridge, UK. david.a.leather@gsk.com.
authors.forename: David
authors.initials: D
authors.lastname: Leather
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000730:Androstadienes / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D001592:Benzyl Alcohols / Q000008:administration & dosage*; D002722:Chlorobenzenes / Q000008:administration & dosage*; D002985:Clinical Protocols; D004311:Double-Blind Method; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D008875:Middle Aged; D006113:United Kingdom
chemical_list: D000730:Androstadienes; D001592:Benzyl Alcohols; D002722:Chlorobenzenes; D005938:Glucocorticoids; C550468:vilanterol; C523187:fluticasone furoate