Relvar Ellipta significantly improves asthma control
Positive results from the Salford Lung Study (SLS) in asthma have been announced by GlaxoSmithKline (GSK) and Innoviva, demonstrating that patients initiated on treatment with Relvar Ellipta significantly improved asthma control compared with usual care.
The open-label, randomised study was performed on 4,233 patients, who were treated by their own GP in everyday clinical practice. Patients were randomised to receive Relvar Ellipta (fluticasone furoate/vilanterol or FF/VI) or to continue on their existing asthma maintenance therapy, which comprised inhaled corticosteroid (ICS) with or without long-acting beta2-agonist (LABA).
Primary endpoint of the study was measured at week 24 in the primary effectiveness analysis population. At this point, patients receiving FF/VI therapy were found to have twice the odds of achieving an improvement in asthma control compared with those continuing treatment.
“I am really excited to see the results from SLS asthma,” said lead investigator, Ashley Woodcock, professor of respiratory medicine and clinical director for respiratory medicine, University Hospital of South Manchester and University of Manchester. “Asthma control continues to be a real challenge for patients and the healthcare community. Poor control is difficult to investigate in a traditional double-blind randomised control trial, where the study design and intrusive monitoring can influence the behaviour 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.”
In the intent-to-treat (ITT) population — those who have been randomised and received at least one prescription study medication — the incidence of serious adverse events (SAE) was the same in both arms. Two assessments relating to pneumonia, which was a safety endpoint of special interest and a regulatory post-authorisation requirement of the EMA, were also performed.
“Despite medical advances, more than half of patients with asthma continue to experience poor control and significant symptoms,” added Eric Dube, senior vice president and head, Global Respiratory Franchise, GSK. “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.”