Relvar Ellipta demonstrated non-inferiority to SeretideAccuhaler in asthma therapy.
GlaxoSmithKline (GSK) and Innoviva recently announced positive results from a non-inferiority lung function clinical trial exploring the impact of switching to an inhaled corticosteroid (ICS) long-acting beta2 antagonist (LABA) combination treatment.
Patients included in the study with well-controlled asthma were able to switch from treatment with Seretide Accuhaler (fluticasone propionate /salmeterol) to treatment with Relvar Ellipta (fluticasone furoate/vilantero), the ICS/LABA combination therapy, without impacting lung function, according to a press release.
“At GSK we are constantly searching for ways in which we can help patients better manage their asthma,” said Eric Dube, senior vice president, global head of Respiratory Franchise at GSK. “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.”
In the study, patients were randomized to receive once-daily Relvar Ellipta treatment or twice-daily Seretide Accuhaler treatment. Patients treated with the once-daily inhaler were observed to maintain lung function comparably to those treated with the twice-daily inhaler, which met the study’s primary endpoint of non-inferiority.
Non-inferiority was measured by change in baseline FEV1 at the end of 24 weeks of treatment with the inhalers, according to GSK.
A third treatment cohort included ICS monotherapy with fluticasone propionate to determine lung function between inhalers, according to the press release. The investigators noted statistically significant improvements among patients treated with Relvar Ellipta.
All grade adverse events observed in the study were consistent with the established safety profile of Relvar Ellipta. Common adverse reactions include pneumonia, upper respiratory tract infection, bronchitis, influenza, sinusitis, among others.
GSK and Innoviva plan to submit the data to the European Medicines Agency, who approved the trial design. Relvar Ellipta has already received approval in Europe to treat patients aged 12 and older with asthma.
In the United States, Relvar Ellipta is approved as Breo Ellipta to treat patients with asthma aged 18 and older.
“We believe the results of this study are important for patients and physicians,” said Mike Aguiar, CEO of Innoviva. “They provide additional evidence that patients with persistent asthma, who are currently treated with a twice-daily ICS/LABA, in this case Seretide, can experience a similar level of benefit in lung function when treated with Relvar Ellipta, which only needs to be taken once a day.”