What is the Salford Lung Study in COPD (SLS COPD)?
SLS COPD was a 52-week, prospective, comparative, open-label, randomised controlled trial (RCT) conducted in the city of Salford in the UK. The study generated effectiveness and safety data for Relvar▼ (fluticasone furoate/vilanterol [FF/VI], 92/22 mcg) in a population of patients with COPD intended to represent that seen in everyday clinical practice. It was the first study of its kind, and had a broad and inclusive patient population with varied lifestyles and comorbidities.1-4
This pioneering study was formed through an innovative and close collaboration between GSK, academia and the entire regional healthcare community (pharmacies, primary care physicians, hospital etc.) of Salford.2
Why was SLS COPD conducted?
Healthcare decision-makers and professional bodies are calling for data in patient populations that are more representative of everyday clinical practice.5,6
SLS COPD helps us to assess the clinical value and potential benefits of Relvar as compared with usual care* for patients with COPD in an everyday practice setting.1,3
When conducting the trial, GSK maintained the scientific rigour of an RCT, but kept as close to an everyday practice experience as possible, through:1,3
- embracing patient population heterogeneity;
- collecting endpoints relevant to patients and healthcare decision-makers;
- comparing Relvar with usual care* treatment.
Data from effectiveness trials can complement traditional RCTs1,3
SLS COPD is intended to provide information on how various factors, such as treatment choice and comorbidities, influence COPD outcomes. The results add to the existing body of Relvar efficacy and safety evidence, in that they provide complementary data in a population intended to represent patients seen in everyday clinical practice.1,3,4 Therefore, this pioneering, new study has the potential to drive change and improve patient wellbeing.1,3
As a leader in therapeutics for respiratory disease, GSK strives to develop products that offer valuable improvements in treatment for patients and healthcare providers.
Hear about one patient’s experience in SLS COPD below:
* Usual care was a physician-determined COPD maintenance treatment in accordance with usual clinical practice. Of all ITT patients with ≥1 moderate/severe exacerbation in the year prior to randomisation (n=2,269), at baseline 88% were on an ICS-containing regimen, 54% were on triple therapy (ICS/LABA + LAMA) and 12% were on a bronchodilation therapy only (LAMA, LABA or LAMA + LABA).1,2
- Bakerly ND et al. The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in chronic obstructive pulmonary disease. Respir Res. 2015; 16:101–1065.
- New JP et al. Obtaining real-world evidence: the Salford Lung Study. Thorax 2014; 69: 1152—1154
- Vestbo J et al. Effectiveness of Fluticasone Furoate-Vilanterol in COPD in Clinical Practice. NEJM. 2016. DOI: 10.1056/NEJMoa1608033.
- Relvar™ Ellipta™ Summary of Product Characteristics. GlaxoSmithKline; 2016.
- ABPI. The Vision for Real World Data – Harnessing the Opportunities in the UK. Sep 2011 (available from: http://www.abpi.org.uk/our-work/library/industry/Documents/Vision-for-Real-World-Data.pdf).
- Treweek S & Zwarenstein M. Making trials matter: pragmatic and explanatory trials and the problem of applicability. Trials 2009; 10: 37.
AB: Last Updated January 2017: MLT_GIB/FFT/0010/17