GSK and Innoviva Present Positive Results from Pioneering Asthma Study

Salford Lung Study’s Results Presented to European Respiratory Congress.

GlaxoSmithKline plc (GSK and Innoviva, Inc. announced the recent presentation and publication of positive results from its Salford Lung Study in Asthma, which demonstrated that Breo Ellipta, the company’s fluticasone furoate/vilanterol combination (called Relvar Ellipta in Europe and elsewhere) outperformed other treatments in controlling asthma symptoms.

The study showed that the combination asthma drug administered in 92/22mcg or 184/22mcg doses was “superior to usual care” in achieving better control of patient’s asthma symptoms over the 12-month duration of the study. Compared to patients taking their present standard-of-care medications, the symptoms of patients taking Breo Ellipta (as measured by the Asthma Control Test or ACT) garnered an ACT total score greater than 20 or an increase from the baseline greater than 3. The companies reported statistically significant findings were also seen at 12, 40 and 52 weeks.

According to GSK and Innoviva, the study was designed to help better understand the effectiveness of an asthma medicine and its performance across broad patient groups, to better reflect how asthma patients are typically managed in everyday clinical care. The open-label, randomized study was carried out in 4,233 patients treated by their own physicians in everyday clinical settings. GSK explained the study had “minimal exclusion criteria, minimal intervention, and involved a broad demographic of patients.” As such said GSK, “90% of screened patients were included in the study, making it more representative of everyday clinical practice than traditional randomized control trials.” At the 24-week primary endpoint, a “significantly higher” percentage (71%) of patients had improved control over symptoms compared to 56% of patients under usual care treatment.

Ashley Woodcock, Clinical Director for Respiratory Medicine, University Hospital of South Manchester and University of Manchester, said living with asthma has a significant negative impact on people’s day to day lives. “Unfortunately, people with asthma often don’t realize 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.”

 

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