The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in chronic obstructive pulmonary disease.
BACKGROUND
New treatments need to be evaluated in real-world clinical practice to account for co-morbidities, adherence and polypharmacy.


METHODS
Patients with chronic obstructive pulmonary disease (COPD), ≥ 40 years old, with exacerbation in the previous 3 years are randomised 1:1 to once-daily fluticasone furoate 100 μg/vilanterol 25 μg in a novel dry-powder inhaler versus continuing their existing therapy. The primary endpoint is the mean annual rate of COPD exacerbations; an electronic medical record allows real-time collection and monitoring of endpoint and safety data.


CONCLUSIONS
The Salford Lung Study is the world's first pragmatic randomised controlled trial of a pre-licensed medication in COPD.


BACKGROUND
Clinicaltrials.gov identifier NCT01551758.
Salford Royal NHS Foundation Trust, Salford, UK. nawar.bakerly@srft.nhs.uk.
Nawar Diar
ND
Bakerly
Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK. ashley.woodcock@manchester.ac.uk.
Ashley
A
Woodcock
Salford Royal NHS Foundation Trust, Salford, UK. john.new@manchester.ac.uk.
John P
JP
New
Salford Royal NHS Foundation Trust, Salford, UK. Martin.Gibson@manchester.ac.uk.
J Martin
JM
Gibson
GlaxoSmithKline, Research Triangle Park, Durham, NC, USA. wei.w.wu@gsk.com.
Wei
W
Wu
GSK Respiratory Centre of Excellence, GlaxoSmithKline UK Ltd, Uxbridge, UK. david.a.leather@gsk.com.
David
D
Leather
Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK. jorgen.vestbo@manchester.ac.uk.|Centre for Respiratory Medicine and Allergy, 2nd Floor Education and Research Centre, University Hospital of South Manchester NHS Foundation Trust, Manchester, M23 9LT, UK. jorgen.vestbo@manchester.ac.uk.
Jørgen
J
Vestbo
D000280:Administration, Inhalation; D000328:Adult; D000336:Aerosols; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects; D001592:Benzyl Alcohols / Q000008:administration & dosage* / Q000009:adverse effects; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002722:Chlorobenzenes / Q000008:administration & dosage* / Q000009:adverse effects; D002985:Clinical Protocols; D018450:Disease Progression; D004334:Drug Administration Schedule; D004338:Drug Combinations; D058995:Dry Powder Inhalers; D057286:Electronic Health Records; D004739:England; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome
D000336:Aerosols; D000730:Androstadienes; D001592:Benzyl Alcohols; D001993:Bronchodilator Agents; D002722:Chlorobenzenes; D004338:Drug Combinations; D005938:Glucocorticoids; C550468:vilanterol; C523187:fluticasone furoate