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), ≥40years old, with exacerbation in the previous 3years are randomised 1:1 to once-daily fluticasone furoate 100μg/vilanterol 25μg 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.