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  • Title: The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in chronic obstructive pulmonary disease.
    Author: Bakerly ND, Woodcock A, New JP, Gibson JM, Wu W, Leather D, Vestbo J.
    Journal: Respir Res; 2015 Sep 04; 16(1):101. PubMed ID: 26337978.
    Abstract:
    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.
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