Positive Results from Pioneering Salford Lung Study Published in The Lancet

GlaxoSmithKline plc and Innoviva Inc have announced positive results from the Salford Lung Study (SLS) in asthma have been simultaneously published in The Lancet journal and presented at the European Respiratory Society (ERS) International Congress in Milan.

The innovative study, which reported headline results in May, showed that that initiation of once-daily Relvar Ellipta (fluticasone furoate ‘FF’/vilanterol ‘VI’ or ‘FF/VI’) 92/22mcg or 184/22mcg was superior to usual care in achieving a consistent improvement in patient’s asthma control over the 12 month study duration.

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The patients' conditions were measured by the Asthma Control Test (ACT) and compared with patients who continued to take their usual care medicines. Improvement was defined as an ACT total score ≥20 or an increase from baseline of ≥3. Statistically significant findings were also seen at 12, 40 and 52 weeks.

The study was designed to explore the effectiveness of an asthma medicine when used with minimal intervention in a broad group of people with asthma, closely reflecting how typical asthma patients are managed in everyday clinical care. For the primary endpoint at 24 weeks, a significantly higher percentage of patients with symptomatic asthma and initiated on treatment with FF/VI achieved better control of their asthma (71%), compared with patients continuing usual care treatment (56%). Usual care treatment included inhaled corticosteroids (ICS) administered as monotherapy or as ICS/LABA (Long Acting Beta Agonist) combinations. This improvement in asthma control for FF/VI was also consistently seen whether patients were on ICS or ICS/LABA as usual care.

Secondary analyses showed that, in addition to better asthma control, patients initiated with FF/VI also achieved higher quality of life scores (as measured by the Asthma Quality-of-Life Questionnaire, AQLQ), and lower impact on their ability to work and take part in activity (as measured by the Work Productivity and Activity Impairment Questionnaire, WPAI):

Read the full article in The Lancet here >>

Safety was also assessed and the safety profile of FF/VI in the SLS study was consistent with the product label for FF/VI. In the study for the intent-to-treat (ITT) population, the incidence of serious adverse events (SAE) was the same in both arms (FF/VI 13% and usual care 13%).

Lead Investigator, Ashley Woodcock, Professor of Respiratory Medicine and Clinical Director for Respiratory Medicine, University Hospital of South Manchester and University of Manchester said: “Living with asthma can have a significant effect on people’s day to day life, from sleeping well at night, to doing exercise, and going to work or school. Unfortunately, people with asthma often don’t realise improvements can be made to these parts of their lives. That’s why research, such as the Salford Lung Studies, are important tools to help the medical community manage asthma in a way that has a positive impact for people living with this debilitating condition. We’re delighted the Lancet has published the results of what I believe to be a pioneering study.”

This innovative open-label, randomised study, was carried out in 4,233 patients treated by their own General Practitioner in everyday clinical practice. The study had minimal exclusion criteria, minimal intervention, and involved a broad demographic of patients. As such 90% of screened patients were included in the study making it more representative of everyday clinical practice than traditional randomised control trials.

Professor Neil Barnes, Global Medical Head, Respiratory Franchise at GSK said: “The Salford Lung Study Programme is the first of its kind. Whilst we set out to measure the effectiveness of our medicine, Relvar/Breo, in every day clinical practice, we also wanted to find a way for doctors to more accurately assess how people live and manage their condition on a day to day basis. Through this unique study, we saw a meaningful impact on the daily lives of people managing asthma with FF/VI compared with usual care. Importantly, the results were consistent across the whole 12 months of the study, and when compared to patients continuing either ICS or ICS/LABA as their usual care.”

Michael W. Aguiar, President and Chief Executive Officer of Innoviva said: “We are pleased with the results of The Salford Lung Study in asthma that are being presented and published today. The Salford Lung Study is important as one of the first clinical effectiveness studies of its kind, providing interesting insights into the management of asthma in clinical care.”

The study design protocol paper can be found here.

Relvar Ellipta is known as Breo Ellipta in the United States.