Format

Send to

Choose Destination
BMC Pulm Med. 2015 Dec 10;15:160. doi: 10.1186/s12890-015-0150-8.

The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in asthma.

Author information

1
Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK. ashley.woodcock@manchester.ac.uk.
2
Salford Royal NHS Foundation Trust, Salford, UK. nawar.bakerly@srft.nhs.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
Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK. jorgen.vestbo@manchester.ac.uk.
7
GSK Respiratory Centre of Excellence, GlaxoSmithKline UK Ltd, Uxbridge, UK. david.a.leather@gsk.com.

Abstract

BACKGROUND:

Novel therapies need to be evaluated in normal clinical practice to allow a true representation of the treatment effectiveness in real-world settings.

METHODS/DESIGN:

The Salford Lung Study is a pragmatic randomised controlled trial in adult asthma, evaluating the clinical effectiveness and safety of once-daily fluticasone furoate (100 μg or 200 μg)/vilanterol 25 μg in a novel dry-powder inhaler, versus existing asthma maintenance therapy. The study was initiated before this investigational treatment was licensed and conducted in real-world clinical practice to consider adherence, co-morbidities, polypharmacy, and real-world factors.

PRIMARY ENDPOINT:

Asthma Control Test at week 24; safety endpoints include the incidence of serious pneumonias. The study utilises the Salford electronic medical record, which allows near to real-time collection and monitoring of safety data.

DISCUSSION:

The Salford Lung Study is the world's first pragmatic randomised controlled trial of a pre-licensed medication in asthma. Use of patients' linked electronic health records to collect clinical endpoints offers minimal disruption to patients and investigators, and also ensures patient safety. This highly innovative study will complement standard double-blind randomised controlled trials in order to improve our understanding of the risk/benefit profile of fluticasone furoate/vilanterol in patients with asthma in real-world settings.

TRIAL REGISTRATION:

Clinicaltrials.gov, NCT01706198; 04 October 2012.

PMID:
26651333
PMCID:
PMC4676141
DOI:
10.1186/s12890-015-0150-8
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for BioMed Central Icon for PubMed Central
Loading ...
Support Center