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GSK, Innoviva’s Relvar Ellipta shows positive effect in non-inferiority lung function study

PBR Staff Writer Published 24 February 2017

GlaxoSmithKline (GSK) and Innoviva’s non-inferiority lung function study of Relvar Ellipta has showed positive effect in patients with well-controlled asthma.

The study showed that patients with well-controlled asthma have been able to change to the once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI) 100/25, an inhaled corticosteroid (ICS)/long-acting beta2 agonist (LABA) combination, from the twice-daily Seretide Accuhaler (fluticasone propionate /salmeterol, FP/SAL) 250/50, without compromising their lung function.

It met the primary endpoint, which was confirmed when patients randomised to FF/VI taken once-daily maintained lung function compared to those randomised to the twice-daily FP/SAL.

To detect a lung function difference between treatments, the study has included third treatment arm with fluticasone propionate (FP), ICS monotherapy.

GSK is planning to present the data from the study to the European Medicines Agency (EMA).

The patients with well controlled asthma were randomised to secure either FF/VI 100/25 once-daily, FP/SAL 250/50 twice-daily or FP 250 twice-daily in a double-blind, double-dummy manner for 24 weeks at multiple centres in 12 countries, following a four-week open-label treatment period with FP/SAL 250/50 twice-daily.

The study’s primary objective is to show non-inferiority of Relvar Ellipta 100/25 once-daily with Seretide Accuhaler 250/50 twice-daily in adult and adolescent subjects 12 years of age and older with persistent bronchial asthma and well controlled on twice-daily ICS/LABA.

According to GSK, the endpoint for the study was the change from baseline in clinic visit evening FEV1 (pre-brochodilator and pre-dose) at the end of the 24-week treatment period.

GSK respiratory franchise global head and SVP Eric Dube said: “In this positive study we have demonstrated non-inferiority for once-daily Relvar versus twice-daily Seretide on lung function.

“This gives us confidence that for patients who struggle taking a twice-daily treatment regimen, there may be a once-daily treatment option available, providing greater physician choice to help patients.”

Image: GlaxoSmithKline head office, London. Photo: courtesy of Ian Wilson.