Date: 2014-03-14
Type of
information: Completion of patient enrollment
phase: 3
Announcement: completion of patient enrollment
Company: GSK (UK) Theravance (USA)
Product: Relvar®/Breo® Ellipta®(fluticasone furoate, vilanterol)
Action
mechanism:
- Breo Ellipta® works by decreasing inflammation in the lungs and helping the muscles around the airways of the lungs stay relaxed to increase airflow and reduce exacerbations in patients with COPD. Relvar® is a combination of the inhaled corticosteroid, fluticasone furoate, and the long-acting beta2-agonist (LABA), vilanterol.
Breo® Ellipta® (FF/VI 100/25mcg) was licensed in May 2013 by the FDA 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.
Disease: chronic obstructive pulmonary disease (COPD)
Therapeutic
area: Respiratory diseases - Inflammatory diseases
Country: Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Israel, Italy, Japan, Republic of Korea, Latvia, Macedonia, Republic of The Former Yugoslav, Malaysia, Mexico, Netherlands, Philippines, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Taiwan, Thailand,Turkey, Ukraine, UK, USAVietnam
Trial
details:
- SUMMIT 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. (NCT01313676)
Latest
news:
- • On March 13, 2014, GSK and Theravance 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 \vilanterol ) 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.
- 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.
Is
general: Yes
