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Clinical Trial
. 2015 Sep 4;16(1):101.
doi: 10.1186/s12931-015-0267-6.

The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in chronic obstructive pulmonary disease

Nawar Diar Bakerly  1 , Ashley Woodcock  2 , John P New  3 , J Martin Gibson  4 , Wei Wu  5 , David Leather  6 , Jørgen Vestbo  7   8
Affiliations
Clinical Trial

The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in chronic obstructive pulmonary disease

Nawar Diar Bakerly et al. Respir Res. .

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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Figures

Fig. 1
Fig. 1
Study design. COPD = chronic obstructive pulmonary disease; DPI = dry-powder inhaler; FF = fluticasone furoate; GP = general practitioner; ICS = inhaled corticosteroid; LABA = long-acting β2-agonist; LAMA = long-acting muscarinic antagonist; Rx = treatment; VI = vilanterol
See this image and copyright information in PMC

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