The clinical trial demonstrated that Relvar Ellipta (fluticasone furoate and vilanterol) could reduce exacerbations compared to usual care, for people with COPD. Usual care involved long-acting muscarinic antagonists (LAMA), long-acting beta2-agonists (LABA), and inhaled corticosteroids (ICS) given as monotherapy in any combination.
The effectiveness analysis showed a significant drop (8%) in the rate of serious exacerbations versus those who were given usual care of FF/VI 100/25mcg of the therapy.
Patrick Vallance, president of Pharmaceuticals R&D, GSK, called the study “genuinely groundbreaking.”
“We have worked closely with the local NHS clinical community to study patients in their everyday setting. 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,” Vallance said. “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 announced today.”
Senior Vice President and Head of Global Respiratory Franchise, GSK, Eric Dube said: “The Salford Lung Study COPD results support the effectiveness of Relvar. As we move beyond the headline results, we will learn so much more about the medicine and disease management. We believe the results could transform understanding of how patients in everyday clinical practice respond to COPD treatments.”
Jørgen Vestbo, a professor of Respiratory Medicine at the Centre for Respiratory Medicine and Allergy at the University Hospital South Manchester NHS Foundation Trust and the University of Manchester, said the trial is just the tip of the iceberg when it comes to understanding drugs used on a daily basis.
“Over the coming months we will understand more about the day-to-day effectiveness of FF/VI and how treatment choice, patient behavior, co-morbidities and other factors combine to influence COPD outcomes,” Vestbo said.
Study results are currently under evaluation. A second Salford Lung Study is also being conducted in patients with asthma.
The Salford Lung Study is an open-label, Phase 3b, controlled, multi-centre, randomized clinical trial mainly aimed at comparing the safety profile and effectiveness of FF/VI treatment and the current COPD therapy/
Included in the study are 2,802 people with COPD who received once a day 100/25mcg FF/VI via the Ellipta inhaler, with or without a LAMA, or on usual therapy.
Participants ratio at 1:1 male and female; the average age was 67. For enrollment, patients were required to have COPD, been given maintenance therapy, and experienced at least one exacerbation over the previous three years with a 12- month-long follow-up period.
The clinical trial is conducted by unique cooperation between GSK, North West e-Health, Salford Royal NHS Foundation Trust, The University of Manchester, NHS Salford and GPs, University Hospital of South Manchester, and community pharmacists in Salford, Trafford and South Manchester.