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“Real-World” Breo Study: A Q&A With GSK’s David Leather

 
• By Jessica Merrill

GlaxoSmithKline is evaluating its once-daily ICS/LABA Breo Ellipta in a “real-world” trial called the Salford Lung Study, with as little intervention from the clinical trial team as possible, to see how the product impacts health outcomes versus existing treatments. David Leather, MD, global medical affairs leader for GSK’s respiratory franchise, is heading the trial and talks about the trial design, challenges, and why the company launched the study in the first place.

GlaxoSmithKline PLC is hoping to use evidence from a “real-world” trial to convince payers that Breo Ellipta (fluticasone/vilanterol) is worth paying for. The aim is to collect data showing Breo, GSK’s new, once-daily inhaled corticosteroid/long-acting beta2 agonist (ICS/LABA) for chronic obstructive pulmonary disease (COPD) improves patient adherence compared with existing twice-daily ICS/LABA treatments and that as a result it improves health outcomes.

To support its case, in 2012, the company initiated an innovative clinical trial called the Salford Lung Study, testing with...

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