A "ground-breaking" UK study has shown that GlaxoSmithKline's Relvar Ellipta is better than the standard of care in reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).
Headline results from the 2,802-patient Salford Lung Study (SLS) in COPD demonstrated that the inhaled therapy achieved a superior reduction in exacerbations versus usual care - which included long-acting muscarinic antagonists (LAMA), long-acting beta2-agonists (LABA), and inhaled corticosteroids (ICS) - in an everyday clinical practice setting.
In patients given Relvar Ellipta (fluticasone/vilanterol, FF/VI) there was a statistically significant reduction of 8.41 percent in the rate of moderate or severe exacerbations compared with those receiving usual care, according to the study, which also showed a similar rate of adverse events between the different treatment groups.
"In this genuinely ground-breaking study we have worked closely with the local NHS clinical community to study patients in their everyday setting," said Patrick Vallance, president of pharmaceuticals R&D at GSK.
"To ensure the results from Salford were as robust as possible, we made a long-term financial investment in the study, including supporting local infrastructure and training. Innovation often means you have to ask challenging questions to make significant advances, and I believe this is what we have achieved in these positive results."
Lead investigator, Jørgen Vestbo, Professor of Respiratory Medicine at the Centre for Respiratory Medicine and Allergy, University Hospital South Manchester NHS Foundation Trust, also noting that, over the coming months, "we will understand more about the day-to-day effectiveness of FF/VI and how treatment choice, patient behaviour, co-morbidities and other factors combine to influence COPD outcomes".
The findings will be particularly sweet for GSK given that in a Phase III trial last year the treatment failed to hit its key survival target.
The drugmaker and its US partner Theravance were assessing whether the therapy (called BREO Ellipta across the Atlantic) lowered the risk of death versus placebo in COPD patients who also have a history of or are at higher risk from cardiovascular disease. But data showed that, while the risk of all-cause mortality was 12.2 percent lower in the treatment arm, this difference was not statistically significant.