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

Respiratory Research
Nawar Diar BakerlyJørgen Vestbo

Abstract

New treatments need to be evaluated in real-world clinical practice to account for co-morbidities, adherence and polypharmacy. 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. The Salford Lung Study is the world's first pragmatic randomised controlled trial of a pre-licensed medication in COPD. Clinicaltrials.gov identifier NCT01551758.

References

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Citations

Apr 1, 2016·Annals of Oncology : Official Journal of the European Society for Medical Oncology·M KoehlerM L Rothenberg
Sep 7, 2016·The New England Journal of Medicine·Jørgen VestboUNKNOWN Salford Lung Study Investigators
May 16, 2017·Journal of Clinical Epidemiology·Paco M WelsingUNKNOWN Work Package 3 of the GetReal Consortium
May 16, 2017·Journal of Clinical Epidemiology·Elaine IrvingUNKNOWN GetReal Work Package 3
Jul 8, 2017·Journal of Evaluation in Clinical Practice·Rafael Dal-Ré
May 2, 2018·Therapeutic Innovation & Regulatory Science·Olga MarchenkoQi Jiang
Aug 11, 2018·Clinical Pharmacology and Therapeutics·Alasdair Breckenridge
Jun 2, 2016·European Respiratory Review : an Official Journal of the European Respiratory Society·Jørgen Vestbo
Feb 23, 2018·The European Respiratory Journal·Ashley WoodcockJørgen Vestbo
Jul 13, 2016·Journal of the American Society of Nephrology : JASN·Laura M DemberMichael F Flessner
Jan 14, 2020·Advances in Therapy·David A LeatherMike Thomas
Jun 27, 2020·The International Journal of Pharmacy Practice·David A LeatherLinda Stephens
Feb 8, 2019·European Clinical Respiratory Journal·Andreas HeddiniChrister Janson
Jun 26, 2020·International Journal of Chronic Obstructive Pulmonary Disease·Donald P TashkinEdward M Kerwin
Apr 9, 2021·Clinical Pharmacology and Therapeutics·Jonathan H WatanabeRobert M Califf
Jun 5, 2021·ERJ Open Research·Catherine HarveyJoanne Fletcher
Oct 23, 2021·Fundamental & Clinical Pharmacology·Mathieu CharvériatUNKNOWN SFPT Translational Research in Pharmacology group

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Clinical Trials Mentioned

NCT01551758

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