Salford Lung Study of Relvar Ellipta (fluticasone furoate/vilanterol) in chronic obstructive pulmonary disease shows treatment superior to standard care- GlaxoSmithKline and Innoviva
GlaxoSmithKline and Innoviva announced positive headline results from the innovative Salford Lung Study (SLS) in Chronic Obstructive Pulmonary Disease (COPD). The study showed that Relvar Ellipta 100/25mcg (fluticasone furoate ‘FF’/vilanterol ‘VI’ or ‘FF/VI’) achieved a superior reduction in exacerbations versus usual care, in patients with COPD, in an everyday clinical practice setting. Usual care included long-acting muscarinic antagonists (LAMA), long-acting beta2-agonists (LABA), and inhaled corticosteroids (ICS) administered as monotherapy, dual or triple combinations.
For the primary effectiveness analysis, in patients treated with FF/VI 100/25mcg there was a statistically significant reduction of 8.41% in the rate of moderate or severe exacerbations compared with those receiving usual care. Within the intent-to-treat population, the incidence of serious adverse events (SAE) was similar between the groups (29% FF/VI, 27% usual care). For pneumonia, an SAE of special interest, FF/VI demonstrated non-inferiority versus usual care (7% FF/VI versus 6% usual care). This endpoint was a regulatory post-authorisation measure requested by the European Medicines Agency (EMA). Analyses remain ongoing and will be the subject of future publications and presentations.