The Salford Lung Study protocol: a pragmatic,randomised phase III real-world effectiveness trial in chronic obstructive pulmonary disease |
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| Authors: | Nawar Diar Bakerly Ashley Woodcock John P. New J. Martin Gibson Wei Wu David Leather J?rgen Vestbo |
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| Affiliation: | .Salford Royal NHS Foundation Trust, Salford, UK ;.Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK ;.GlaxoSmithKline, Research Triangle Park, Durham, NC USA ;.GSK Respiratory Centre of Excellence, GlaxoSmithKline UK Ltd, Uxbridge, 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 |
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| Abstract: | BackgroundNew treatments need to be evaluated in real-world clinical practice to account for co-morbidities, adherence and polypharmacy.MethodsPatients 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.ConclusionsThe Salford Lung Study is the world’s first pragmatic randomised controlled trial of a pre-licensed medication in COPD.Trial registrationClinicaltrials.gov identifier {"type":"clinical-trial","attrs":{"text":"NCT01551758","term_id":"NCT01551758"}}NCT01551758. |
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