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Respir Res. 2015 Sep 4;16:101. 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.

Author information

1
Salford Royal NHS Foundation Trust, Salford, UK. nawar.bakerly@srft.nhs.uk.
2
Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK. ashley.woodcock@manchester.ac.uk.
3
Salford Royal NHS Foundation Trust, Salford, UK. john.new@manchester.ac.uk.
4
Salford Royal NHS Foundation Trust, Salford, UK. Martin.Gibson@manchester.ac.uk.
5
GlaxoSmithKline, Research Triangle Park, Durham, NC, USA. wei.w.wu@gsk.com.
6
GSK Respiratory Centre of Excellence, GlaxoSmithKline UK Ltd, Uxbridge, UK. david.a.leather@gsk.com.
7
Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK. jorgen.vestbo@manchester.ac.uk.
8
Centre for Respiratory Medicine and Allergy, 2nd Floor Education and Research Centre, University Hospital of South Manchester NHS Foundation Trust, Manchester, M23 9LT, UK. jorgen.vestbo@manchester.ac.uk.

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.

PMID:
26337978
PMCID:
PMC4558879
DOI:
10.1186/s12931-015-0267-6
[Indexed for MEDLINE]
Free PMC Article

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