GlaxoSmithKline and Innoviva have unveiled data from a second ground-breaking Salford Lung Study (SLS) showing that Relvar Ellipta significantly improved asthma control versus patients’ standard therapy.
Patients initiated with Relvar Ellipta (fluticasone furoate/FF and vilanterol/VI) had twice the odds of achieving an improvement in asthma control than those continuing with their usual care, which included inhaled corticosteroids (ICS) administered as monotherapy or as ICS/LABA (long acting beta agonist) combinations.
The SLS is a 4,000-patient-plus Phase III multi-centre, open label randomised controlled trial, designed to compare the effectiveness and safety profile of initiating treatment with FF/VI with usual asthma maintenance therapy over a 52 week period.
The trial, which adds to the existing data set from double blind randomised clinical studies, is intended to enable healthcare professionals to more accurately assess the potential value of FF/VI by providing data collected in a normal clinical practice setting, which is representative of how healthcare professionals and patients may use the medicine in everyday life.
According to the data, at 24 weeks patients with uncontrolled asthma initiated on treatment with FF/VI achieved better control of their asthma (71 percent) measured by the Asthma Control Test (ACT), compared with the control group (56 percent).
Also, in the study for the intent-to-treat population, the incidence of serious adverse events (SAE) was the same in both arms (13 percent).
“Asthma control remains a significant unmet medical need in the daily lives for many patients. We believe that this positive real world data successfully builds upon the previous clinical data to provide strong evidence of the benefits of Relvar Ellipta for the treatment of asthma,” said Michael W. Aguiar, Innoviva’s president and chief executive.
The first SLS study in patients with COPD demonstrated that the inhaled therapy achieved a superior reduction in exacerbations versus usual care.