GlaxoSmithKline plc (GSK) and biopharmaceutical company Theravance, Inc. have announced that recruitment of patients into the “Study to Understand Mortality and MorbidITy”, known as SUMMIT, has completed enrolment. The aim of this study, which has now enrolled approximately 16,000 patients, is to determine the impact of Relvar/Breo Ellipta (fluticasone furoate ‘FF’/vilanterol ‘VI’) on all cause mortality amongst patients with moderate chronic obstructive pulmonary disease (COPD) who have cardiovascular disease (CVD) or are at increased risk for CVD.
SUMMIT (NCT01313676) is a multicentre, double-blind, parallel-group, placebo-controlled study of approximately 16,000 patients with moderate COPD and a history of or increased risk for cardiovascular disease who are randomised to receive either once daily treatment with fluticasone furoate/vilanterol (100/25mcg), fluticasone furoate (100mcg), vilanterol (25mcg) or placebo. The primary objective is to evaluate the effect of FF/VI compared with placebo on survival evaluated by the primary endpoint of all-cause mortality. The secondary endpoints are rate of decline in forced expiratory volume in 1 second (FEV1) and a composite cardiovascular endpoint.
As an event-driven study, the exact duration of the treatment phase will depend on the mortality rate within the study. However, it is anticipated that each patient will participate in the study for between 16-53 months.
Darrell Baker, SVP and Head, Global Respiratory Franchise, GSK said, “We are very pleased to have completed recruitment in this large study and initiated the final patient onto treatment. We hope that results from this study will increase our understanding of cardiovascular comorbidity in COPD, and of the effects of Relvar/Breo Ellipta when used to manage COPD.”
Rick E Winningham, chief executive officer of Theravance said, “There is limited understanding of the relationship between COPD and cardiovascular disease or the potential to affect patient outcomes. We believe that, once available, the results from this landmark study will enhance our knowledge of these co-morbid conditions and provide important information about treatment with Relvar/Breo in a COPD population with cardiovascular risk factors.”
Breo Ellipta (FF/VI 100/25mcg) was licensed in May 2013 by the US Food and Drug Administration for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Breo Ellipta is not indicated for the relief of acute bronchospasm or the treatment of asthma in the US.
Relvar Ellipta was also approved by the European Medicines Agency (EMA) in November 2013 for the symptomatic treatment of adults with chronic obstructive pulmonary disease (COPD) with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy. One strength has been licensed for the treatment of COPD (92/22 mcg) and is administered once-daily using Ellipta, a dry powder inhaler (DPI). EMA EPAR including summary of product characteristics.
FF/VI is not approved or licensed anywhere in the world to reduce mortality due to CV co-morbidities associated with COPD.
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies.