葛兰素史克（GSK）与合作伙伴Theravance公司3月13日联合宣布，有关新复方药Relvar Ellipta（fluticasone furoate/vilanterol，FF/VI，美国商品名为Breo Ellipta）的一项具有里程碑意义的III期研究SUMMIT已完成患者招募工作。该项研究现已招募约1.6万例慢性阻塞性肺病（COPD）患者，研究的目的是调查Relvar/Breo Ellipta用于伴有心血管疾病（CVD）或CVD风险升高的中度COPD群体时，对全因死亡率（all cause mortality）的影响。

SUMMIT是一项多中心、双盲、平行组、安慰剂对照研究，涉及约1.6万名具有心血管疾病病史或心血管病风险升高的中度慢性阻塞性肺病（COPD）患者。研究中，患者随机接受fluticasone furoate/vilanterol（FF/VI，100/25mcg）、fluticasone furoate（FF，100mcg）、vilanterol（VI，25mcg）或安慰剂治疗。研究的主要目的是评价FF/VI相对于安慰剂对整体存活率（以全因死亡率评价，研究的主要终点）的影响。次要终点包括一秒用力呼气容积(FEV1)的下降速度和复合心血管终点。

FF/VI为每日1次的吸入型糖皮质激素（ICS）糠酸氟替卡松(FF)和长效β2受体激动剂（LABA）维兰特罗(VI)的复方药物，采用新型干粉吸入器（DPI）Ellipta给药，该药开发用于慢性阻塞性肺病（COPD）和哮喘（asthma）的治疗。

2013年5月，FF/VI获FDA批准，商品名为Breo Ellipta，作为每日一次的吸入性疗法，用于慢性阻塞性肺病（COPD）患者的长期维持治疗，包括慢性支气管炎和/或肺气肿。此外，该药还适用于既往有COPD病情加重(COPD exacerbation)病史患者的COPD病情加重的减少。

2013年11月，FF/VI获欧盟批准，商品名为Relvar Ellipta，做为每日一次的吸入性疗法，用于哮喘（asthma ）和慢性阻塞性肺病（COPD）的治疗。

目前，FF/VI还未获批用于降低心血管疾病-COPD并发症所致的死亡率。

Patient recruitment completes in landmark RELVAR®/ BREO® ELLIPTA® Study to Understand Mortality and MorbidITy (SUMMIT) in COPD

Issued: Thursday 13 March 2014, London UK and South San Francisco, CA, USA

GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today 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.

About FF/VI

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.

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