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

Nawar Diar Bakerly; Ashley Woodcock; John P New; J Martin Gibson; Wei Wu; David Leather; Jørgen Vestbo

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

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

Authors

Nawar Diar Bakerly¹, Ashley Woodcock², John P New³, J Martin Gibson⁴, Wei Wu⁵, David Leather⁶, Jørgen Vestbo^{7

8}

Affiliations

¹ Salford Royal NHS Foundation Trust, Salford, UK. [email protected].
² Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK. [email protected].
³ Salford Royal NHS Foundation Trust, Salford, UK. [email protected].
⁴ Salford Royal NHS Foundation Trust, Salford, UK. [email protected].
⁵ GlaxoSmithKline, Research Triangle Park, Durham, NC, USA. [email protected].
⁶ GSK Respiratory Centre of Excellence, GlaxoSmithKline UK Ltd, Uxbridge, UK. [email protected].
⁷ Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK. [email protected].
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. [email protected].

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.

Publication types

Clinical Trial, Phase III
Multicenter Study
Pragmatic Clinical Trial
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Administration, Inhalation
Adult
Aerosols
Androstadienes / administration & dosage*
Androstadienes / adverse effects
Benzyl Alcohols / administration & dosage*
Benzyl Alcohols / adverse effects
Bronchodilator Agents / administration & dosage*
Bronchodilator Agents / adverse effects
Chlorobenzenes / administration & dosage*
Chlorobenzenes / adverse effects
Clinical Protocols
Disease Progression
Drug Administration Schedule
Drug Combinations
Dry Powder Inhalers
Electronic Health Records
England
Female
Glucocorticoids / administration & dosage*
Glucocorticoids / adverse effects
Humans
Lung / drug effects*
Lung / physiopathology
Male
Pulmonary Disease, Chronic Obstructive / diagnosis
Pulmonary Disease, Chronic Obstructive / drug therapy*
Pulmonary Disease, Chronic Obstructive / physiopathology
Research Design
Time Factors
Treatment Outcome

Substances

Aerosols
Androstadienes
Benzyl Alcohols
Bronchodilator Agents
Chlorobenzenes
Drug Combinations
Glucocorticoids
vilanterol
fluticasone furoate

Associated data

ClinicalTrials.gov/NCT01551758