The Salford Lung Study: Rethinking Clinical Trial Design by Assessing Effectiveness in Clinical Practice
Woodcock A.
RDD Europe 2017. Volume 1, 2017: 35-42.
Abstract:
The Salford Lung Study program is a pre-license pragmatic randomized controlled trial involving two studies, to evaluate the effectiveness and safety of a novel, once-daily treatment Relvar® Ellipta® (fluticasone furoate-vilanterol) for asthma, and for chronic obstructive pulmonary disease (COPD) compared with existing maintenance therapy, in everyday clinical practice.
In the COPD study, the effectiveness of fluticasone furoate-vilanterol was determined in a prospective, 12-month open-label, parallel group, randomized trial conducted in 75 general practices in Salford and South Manchester, United Kingdom. 2,802 COPD patients were randomly assigned to either a once-daily inhaled combination of 100 μg fluticasone furoate and 25 μg vilanterol or usual care. Effectiveness and safety data were monitored and collected in near real-time using an electronic health record. The once-daily treatment regimen of combined fluticasone furoate and vilanterol was associated with a lower rate of exacerbations than usual care, across all treatment groups, without a greater risk of serious adverse events. This kind of ‘real world’ study, focusing on meaningful endpoints and not using tight exclusion criteria, will reshape the future of clinical trials.
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