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The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in chronic obstructive pulmonary disease #MMPMID26337978
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 ?g/vilanterol 25 ?g 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. Trial registration: Clinicaltrials.gov identifier NCT01551758.