GlaxoSmithKline plc (GSK) and Innoviva, Inc. announced positive headline results from a non-inferiority lung function study, which demonstrated that patients with well-controlled asthma were able to switch 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.

Patients randomised to FF/VI taken once-daily maintained lung function comparable with those randomised to the twice-daily FP/SAL [difference +19mL (95% CI: -11mL, +49mL], meeting the study’s primary endpoint, based on the lower bound (-11ml) of the 95% confidence interval falling above the non-inferiority margin of -100mL.

A third treatment arm with fluticasone propionate (FP), ICS monotherapy, was included to detect a lung function difference between treatments. Results demonstrated statistically significant differences in favour of the ICS/LABA combinations to FP (p<0.001).

The incidences of on-treatment serious adverse events (SAEs) and adverse events (AEs) of special interest were consistent with the known safety profile of FF/VI, established in asthma patients from other studies.

Eric Dube, SVP and global head of respiratory franchise, GSK said: At GSK we are constantly searching for ways in which we can help patients better manage their asthma. 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.”

Mike Aguiar, CEO of Innoviva, Inc., added: “We believe the results of this study are important for patients and physicians. 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.”

The study design was agreed with European regulatory authorities. GSK now intends to submit this data to the European Medicines Agency (EMA).

Results from the study will be shared in future publications and presentations.

Following a 4-week open-label treatment period with FP/SAL 250/50 twice-daily, patients with well controlled asthma were randomised to receive 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.

The primary objective of the study was to demonstrate 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, well controlled on twice-daily ICS/LABA. 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.

To demonstrate the non inferiority of FF/VI vs FP/SAL the lower limit of the 95% confidence interval for the mean difference in change from baseline for evening FEV1 needed to be greater than the pre defined margin of -100mL. This was to rule out the possibility that FF/VI was more than -100mL inferior to FP/SAL.

Relvar Ellipta is a once-daily dual combination treatment comprising fluticasone furoate, an inhaled corticosteroid and vilanterol, a long-acting beta2-agonist, in a single inhaler, the Ellipta.

Relvar Ellipta is indicated in Europe in the regular treatment of patients aged 12 and over with asthma, where use of a combination product (long-acting ß2–agonist, LABA, and inhaled corticosteroid, ICS) is appropriate: Patients not adequately controlled on both ICS and 'as-needed' short-acting ß2-agonist (SABA).