Published in:
Open Access 01-12-2015 | Research
The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in chronic obstructive pulmonary disease
Published in: Respiratory Research | Issue 1/2015
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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.
Trial registration
Clinicaltrials.gov identifier NCT01551758.