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May 7, 2017

GSK and Innoviva report positive results from Phase III trial of Relvar Ellipta to treat asthma

UK-based GlaxoSmithKline (GSK) and US-based Innoviva have reported positive results from the Phase III clinical trial of Relvar Ellipta to treat patients with asthma.

UK-based GlaxoSmithKline (GSK) and US-based Innoviva have reported positive results from the Phase III clinical trial of Relvar Ellipta to treat patients with asthma.

Relvar Ellipta is a once-daily combination of an inhaled corticosteroid known as fluticasone furoate and a long-acting beta2-agonist vilanterol in a single inhaler, Ellipta.

The results showed that patients treated with Relvar Ellipta achieved better asthma control at week 24 when compared to those receiving standard of care treatments such as inhaled corticosteroids (ICS) or ICS in combination with a long-acting beta agonist (LABA).

Similar statistically significant improvement was observed at weeks 12, 40 and 52.

The multi-centre, open label randomised controlled Phase III trial known as salford lung study (SLS) evaluated 100mcg / 25mcg or 200mcg / 25mcg of Relvar Ellipta in 4,233 patients over 52 weeks.

Patients received the doses from their own general practitioner in everyday clinical practice.

GSK global respiratory franchise senior vice-president and head Eric Dube said: "The primary endpoint of this study showed that patients initiated with Relvar Ellipta treatment had double the odds of achieving an improvement in asthma control compared with patients continuing usual care in this study in everyday clinical practice.

"Relvar Ellipta is a once-daily combination of an inhaled corticosteroid known as fluticasone furoate and a long-acting beta2-agonist vilanterol in a single inhaler, Ellipta."

"This study has been a tremendous partnership effort between healthcare professionals, patients, academics and GSK and we would like to thank everyone who has helped to make this unique study possible.”

The main objective of the trial was to determine the effectiveness and safety profile of Relvar Ellipta compared to usual asthma maintenance therapy.

The incidence of serious adverse events (SAE) was found to be the same in both cases.

Previously, Relvar Ellipta also demonstrated a positive outcome in a clinical trial conducted for the treatment of patients with chronic obstructive pulmonary disease.


Image: Histopathology of asthma. Photo: courtesy of Yale Rosen/flickr.

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