Guidelines on the management of chronic obstructive pulmonary disease (COPD) are based on numerous randomized, controlled trials of efficacy, which are usually generated for registration purposes. However, these trials have included patients who were selected with the use of strict criteria and were closely monitored, and therefore the results have limited relevance to everyday clinical practice. To counter this, it has been proposed that integrated comparative effectiveness trials involve more representative patients and be conducted in much less restricted environments.
The Salford Lung Study was designed to evaluate the effectiveness and safety of the once-daily inhaled combination of fluticasone furoate and vilanterol (fluticasone furoate–vilanterol) as compared with existing maintenance therapy (usual care) in a large, real-world population of patients with COPD in conditions of normal care. The trial was initiated before the approval of fluticasone furoate–vilanterol in the United Kingdom and was conducted in and around Salford, United Kingdom, a community served mainly by a single hospital with an established electronic health record (EHR) system that connects primary and secondary care. This setting permits the unobtrusive observation of patients for effectiveness and safety monitoring, blended into routine clinical care.
Authors: Jørgen Vestbo, D.M.Sc., David Leather, M.B., Ch.B., Nawar Diar Bakerly, M.D., John New, M.B., B.S., J. Martin Gibson, Ph.D., Sheila McCorkindale, M.B., Ch.B., Susan Collier, M.B., Ch.B., Jodie Crawford, M.Sc., Lucy Frith, M.Sc., Catherine Harvey, D.Phil., Henrik Svedsater, Ph.D., and Ashley Woodcock, M.D., for the Salford Lung Study Investigators
The New England Journal of Medicine, September 4, 2016DOI: 10.1056/NEJMoa1608033