COPD三联疗法（FF/UMEC/VI)III期临床研究启动（IMPACT试验）

葛兰素史克（GSK）和Theravance公司近日联合宣布，启动慢性阻塞性肺病（COPD）三联疗法（FF/UMEC/VI）III期临床项目首个全球、关键III期IMPACT研究。该三联疗法（FF/UMEC/VI）是一种ICS/LAMA/LABA组合疗法，IMPACT研究将评估该三联疗法（FF/UMEC/VI）用于COPD治疗的疗效和安全性。

IMPACT是一项双盲、3个治疗组、平行组研究，将招募约10000例COPD患者，将评估三联疗法【FF（Fluticasone furoate，糠酸氟替卡松，一种吸入性皮质类固醇，ICS）+UMEC（umeclidinium，一种长效毒蕈碱拮抗剂，LAMA）+VI（vilanterol，维兰特罗，一种长效β2受体激动剂，LABA）】相对于2种已获批的COPD药物【Relvar/Breo Ellipta（FF/VI，一种ICS/LABA复方药物）和Anoro Ellipta（UMEC/VI，一种LAMA/LABA复方药物）】的疗效，是否能降低中度至重度发作（exacerbation）的年发作率。研究中，患者将随机分配至每日一次的FF/UMEC/VI(100/62.5/25mcg)或FF/VI（100/25mcg）或UMEC/VI（62.5/25mcg），治疗周期为52周。

该研究的共同主要终点是：比较FF/UMEC/VI治疗组和FF/VI治疗组中度和重度发作的年发作率；比较FF/UMEC/VI治疗组和UMEC/VI治疗组中度和重度发作的年发作率。关键次要终点包括：比较FF/UMEC/VI治疗组和FF/VI治疗组肺功能（FEV1）基线变化，研究中3个治疗组发生首次中度至重度发作的时间，3个治疗组重度发作的年发作率。

原始出处：
Bateman ED, Mahler DA, Vogelmeier CF, Wedzicha JA, Patalano F, Banerji D.Recent advances in COPD disease management with fixed-dose long-acting combination therapies.Expert Rev Respir Med. 2014 Jun;8(3):357-79.

相关临床试验链接：
A Study Comparing the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of FF/UMEC/VI With the FDC of FF/VI and UMEC/VI; Administered Once-daily Via a Dry Powder Inhaler (DPI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

关于Relvar/Breo Elipta：

Relvar/Breo Ellipta是COPD新复方药物FF/VI（fluticasone furoate /vilanterol）的商品名，采用新型干粉吸入器（DPI）Ellipta给药，该药为每日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，开发用于慢性阻塞性肺病（COPD）和哮喘（asthma）的治疗。该药已分别于2013年5月和11月获FDA(美国商品名为Breo Ellipta)和欧盟（商品名为Relvar Ellipta）批准。

关于Anoro Ellipta：

Anoro Ellipta是COPD新复方药物UMEC/VI（umeclidinium/vilanterol，62.5/25 mcg）的商品名，该药结合了2种长效支气管扩张剂，为长效毒蕈碱受体拮抗剂（LAMA）UMEC（umeclidinium）和长效β2受体激动剂维兰特罗(VI，vilanterol)的复方药物，通过新型干粉吸入器Ellipta给药。Anoro Ellipta是葛兰素史克的一个独特产品，已分别于2013年12月和2014年5月获FDA和欧盟批准。

英文原文：GSK and Theravance announce initiation of phase III programme with fixed dose triple combination treatment FF/UMEC/VI in patients with COPD

GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the start of a global phase III study, known as IMPACT, to evaluate the efficacy and safety of the ‘closed’ triple combination of FF/UMEC/VI in patients with chronic obstructive pulmonary disease (COPD). IMPACT is the first pivotal phase III study in a programme to evaluate a once-daily closed triple combination treatment of an inhaled corticosteroid (ICS); a long-acting muscarinic antagonist (LAMA); and a long-acting beta2-adrenergic agonist (LABA) in patients with COPD.

The IMPACT study will enrol approximately 10,000 patients and assess whether the combination of FF (fluticasone furoate, an ICS), UMEC (umeclidinium, a LAMA) and VI (vilanterol, a LABA), all delivered in GSK’s Ellipta inhaler, can reduce the annual rate of moderate and severe exacerbations compared with two approved once daily COPD treatments, Relvar/Breo Ellipta (FF/VI), which is an ICS/LABA combination, and Anoro Ellipta (UMEC/VI), which is a LAMA/LABA combination.

About the IMPACT study

IMPACT (InforMing the PAthway of COPD Treatment) is a double-blind, three-arm, parallel group study enrolling a total of 10,000 patients across 38 countries. Eligible patients will be randomised to receive either FF/UMEC/VI 100/62.5/25mcg, FF/VI 100/25mcg or UMEC/VI 62.5/25mcg once-daily for a period of 52 weeks.

The co-primary endpoints of the study are: the annual rate of moderate and severe exacerbations comparing FF/UMEC/VI with FF/VI; and the annual rate of moderate and severe exacerbations comparing FF/UMEC/VI with UMEC/VI. Key secondary endpoints include baseline changes in lung function (trough FEV1) comparing FF/UMEC/VI and FF/VI; time to first moderate or severe exacerbation in all three arms of the study; and the annual rate of severe exacerbations in all three arms of the study.

About COPD

Chronic obstructive pulmonary disease is a disease of the lungs that includes chronic bronchitis, emphysema or both. COPD is characterised by obstruction to airflow that interferes with normal breathing.

Long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD1. Cigarette smoke, breathing in second-hand smoke, air pollution, chemical fumes or dust from the environment or workplace can all contribute to COPD1. Most people who have COPD are at least 40 years old when symptoms begin.

About Relvar®/Breo® Ellipta® (fluticasone furoate + vilanterol)

Relvar/Breo Ellipta is a once-daily dual combination treatment comprising fluticasone furoate, an inhaled corticosteroid and vilanterol, a long-acting beta2-agonist, in a single inhaler, the Ellipta®. Full US prescribing information, including BOXED WARNING and Medication Guide is available at us.gsk.com or US Prescribing Information for Breo Ellipta.

About Anoro® Ellipta® (umeclidinium + vilanterol)

Anoro Ellipta is a once-daily combination treatment comprising two bronchodilators: umeclidinium, a long-acting muscarinic antagonist, and vilanterol, a long-acting beta2 agonist, in a single inhaler, the Ellipta®. Full US prescribing information, including BOXED WARNING and Medication Guide is available at: http://us.gsk.com/products/assets/us_anoro_ellipta.pdf.RELVAR®, BREO®, ANORO® and ELLIPTA® are trademarks of the GlaxoSmithKline group of companies.