A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)

Summary

This study is designed to compare the effectiveness and safety of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444)) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with the existing COPD maintenance therapy over twelve months in subjects diagnosed with COPD. This is a Phase III multi-centre, randomised open label study. Subjects who meet the eligibility criteria are randomised and will enter a 12 month treatment period.

Timeline

Start

2012-03-13

Primary completion

2015-11-24

Completion

2015-11-24

Publications

• Vestbo J, Waterer G, Leather D, Crim C, Diar Bakerly N, Frith L, Jacques L, Harvey C, Satia I, Woodcock A; Salford Lung Study Investigators. Mortality after admission with pneumonia is higher than after admission with an exacerbation of COPD. Eur Respir J. 2022 May 19;59(5):2102899. doi: 10.1183/13993003.02899-2021. Print 2022 May.
• Bakerly ND, Browning D, Boucot I, Crawford J, McCorkindale S, Stein N, New JP. The impact of fluticasone furoate/vilanterol on healthcare resource utilisation in the Salford Lung Study in chronic obstructive pulmonary disease. Ther Adv Respir Dis. 2021 Jan-Dec;15:17534666211001013. doi: 10.1177/17534666211001013.
• Sperrin M, Webb DJ, Patel P, Davis KJ, Collier S, Pate A, Leather DA, Pimenta JM. Chronic obstructive pulmonary disease exacerbation episodes derived from electronic health record data validated using clinical trial data. Pharmacoepidemiol Drug Saf. 2019 Oct;28(10):1369-1376. doi: 10.1002/pds.4883. Epub 2019 Aug 5.
• Bakerly ND, Woodcock A, Collier S, Leather DA, New JP, Crawford J, Harvey C, Vestbo J, Boucot I. Benefit and safety of fluticasone furoate/vilanterol in the Salford Lung Study in chronic obstructive pulmonary disease (SLS COPD) according to baseline patient characteristics and treatment subgroups. Respir Med. 2019 Feb;147:58-65. doi: 10.1016/j.rmed.2018.12.016. Epub 2019 Jan 10.
• Woodcock A, Boucot I, Leather DA, Crawford J, Collier S, Bakerly ND, Hilton E, Vestbo J. Effectiveness versus efficacy trials in COPD: how study design influences outcomes and applicability. Eur Respir J. 2018 Feb 21;51(2):1701531. doi: 10.1183/13993003.01531-2017. Print 2018 Feb.
• Vestbo J, Leather D, Diar Bakerly N, New J, Gibson JM, McCorkindale S, Collier S, Crawford J, Frith L, Harvey C, Svedsater H, Woodcock A; Salford Lung Study Investigators. Effectiveness of Fluticasone Furoate-Vilanterol for COPD in Clinical Practice. N Engl J Med. 2016 Sep 29;375(13):1253-60. doi: 10.1056/NEJMoa1608033. Epub 2016 Sep 4.
• Bakerly ND, Woodcock A, New JP, Gibson JM, Wu W, Leather D, Vestbo J. 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.
• New JP, Bakerly ND, Leather D, Woodcock A. Obtaining real-world evidence: the Salford Lung Study. Thorax. 2014 Dec;69(12):1152-4. doi: 10.1136/thoraxjnl-2014-205259. Epub 2014 Mar 6.

Drugs

Indications