UK-based pharmaceutical firm GlaxoSmithKline (GSK) and US-based healthcare firm Innoviva have reported positive headline results from a non-inferiority lung function study of relvar ellipta in patients with well-controlled asthma.
Relvar ellipta is a once-daily dual combination of inhaled corticosteroid fluticasone furoate and beta-2 agonist vilanterol in a single inhaler, the Ellipta.
The results showed that patients with well-controlled asthma were able to switch to the once-daily relvar ellipta 100/25 from the twice-daily seretide accuhaler 250/50 without any affect on their lung function.
Seretide accuhaler is a twice-daily dual combination of fluticasone propionate / salmeterol in the Accuhaler inhaler.
The randomised, double-blind, double-dummy European Medicines Agency (EMA) approved study was conducted at multiple centres in 12 countries.
The study’s primary objective was to establish the non-inferiority of relvar ellipta 100/25 once-daily, when compared to seretide accuhaler 250/50 twice-daily in adult and adolescent subjects 12 years of age and older with persistent bronchial asthma.
The study endpoint was the change from baseline during clinic visit evening FEV1 (pre-brochodilator and pre-dose) at the end of the 24-week treatment period.
The patients administered with relvar ellipta were found to maintain a better lung function when compared to patients who were given seretide accuhaler.
The study also included a third treatment arm with fluticasone propionate (FP), inhaled corticosteroid monotherapy to identify the lung function difference between treatments.
The serious adverse events (SAEs) and adverse events (AEs) were found to be consistent with the safety profile of relvar ellipta that was determined through previous studies.
Relvar ellipta is currently indicated in Europe for the regular treatment of patients aged 12 and above with asthma.