GlaxoSmithKline and Innoviva have announced that data from the real world Salford Lung Study show that asthma patients using Relvar (Breo) Ellipa fluticasone furoate/vilanterol 100/25μg or 200/25μg had improved asthma control compared to those using their usual care, either ICS or ICS/LABA combinations. Relvar Ellipta was approved for the treatment of asthma in the EU in 2013.
The Phase 3, open-label, randomized Salford Lung Study in asthma enrolled 4,233 patients who were treated by their usual medical professionals in their usual settings. Patients using Relvar Ellipta had better statistically significantly better control of their asthma than patients given usual care at 12, 24, 40, and 52 weeks. The incidence of serious adverse events was the same for patients using Relvar Ellipta vs usual care.
Lead Investigator Ashley Woodcock of the University of Manchester commented, “I am really excited to see the results from SLS asthma. Asthma control continues to be a real challenge for patients and the healthcare community. Poor control can have a major impact on the lives of asthma patients. The effectiveness of different treatments on asthma control is difficult to investigate in a traditional double-blind randomized control trial, where the study design and intrusive monitoring can influence the behavior of patients. In SLS, patient relevant outcomes are the major endpoints. GSK should be congratulated for running this unique study, designed to understand how asthma medicines work in everyday clinical practice.”
GSK Senior VP and Head, Global Respiratory Franchise Eric Dube said, “Despite medical advances, more than half of patients with asthma continue to experience poor control and significant symptoms. The primary endpoint of this study showed that patients initiated with Relvar Ellipta treatment had twice the odds of achieving an improvement in asthma control compared with patients continuing usual care in this study in everyday clinical practice. This study has been a tremendous partnership effort between healthcare professionals, patients, academics and GSK and we would like to thank everyone who has helped to make this unique study possible.”
Read the GSK and Innoviva press release.
