2014年4月26日讯  诺华（Novartis）4月25日宣布，在慢性阻塞性肺病（COPD）患者中开展的IV期INSTEAD切换研究达到了非劣性主要终点。

INSTEAD是一项全球、随机、双盲、平行组、26周IV期研究，在581例具有病情加重低风险的中度COPD患者中开展，这些患者此前一直接受Seretide（商品名：舒利迭，通用名：沙美特罗/氟替卡松（SFC），salmeterol/fluticasone，50/500mcg，每日2次）治疗至少3个月，并在过去的1年中未发生急性发作。研究中，将患者随机分配至继续接受Seretide治疗，或切换至Onbrez Breezhaler（商品名：昂润，通用名：茚达特罗，indacaterol，150mcg，每日1次）治疗。研究的主要目的是证明治疗12周后Onbrez Breezhaler相对于Seretide对肺功能（FEV1）改善的非劣性。

该项研究达到了非劣性主要终点。此外，数据还表明，Onbrez Breezhaler治疗组和Seretide治疗组在治疗12周和26周后具有类似的症状（呼吸短促和健康状况）改善。该项研究中，OnbrezBreezhaler的安全性与此前III期研究中一致，研究的详细数据将提交至2014年晚些时候举行的医疗会议。

该项研究的积极数据，有助于病情加重（exacerbation）低风险的中度慢性阻塞性肺病（COPD）群体从Seretide转向Onbrez Breezhaler治疗，同时证实对于该群体，Onbrez Breezhaler是一种有效的维持性治疗选择。此外，这些数据支持了COPD治疗的国际准则，该准则建议，鉴于吸入性糖皮质激素（inhaled corticosteroids，ICS）的长期风险，不应将ICS用于病情加重风险较低的COPD群体的治疗。

在全球范围内，约有2.1亿慢性阻塞性肺病（COPD）患者，预计到2020年，该病将成为第三大死亡病因。能有效控制COPD症状并帮助患者维持其日常活动的药物，对于解决COPD管理中为满足的医疗需求至关重要。

关于Onbrez Breezhaler（昂润）：

Onbrez Breezhaler（昂润，茚达特罗吸入粉雾剂，indacaterol）是诺华开发的一种支气管舒张剂，为每日一次的吸入性长效（24小时）β2-肾上腺素能激动剂（LABA），该药在给药5分钟内便能迅速起效，并维持24小时的支气管扩张。与噻托溴铵（tiotropuim）18 mcg相比，150 mcg剂量Onbrez Breezhaler能够提供更显著的临床利益，表现减少呼吸短促、减少急救药物的使用、改善身体状况。

Onbrez Breezhaler最初获欧盟批准，获批剂量为150 mcg和300 mcg（每日一次），用于治疗COPD成人患者的气流阻塞。目前，该药已获全球100多个国家批准，包括日本（Onbrezlnhalation Capsules，150mcg，每日一次）和美国（商品名Arcapta Neohaler 75mcg，每日一次）。

关于Seretide（舒利迭）：

Seretide（舒利迭，沙美特罗/氟替卡松干粉吸入剂）是葛兰素史克（GSK）开发的COPD药物，可产生至少持续12小时的支气管扩张作用，每日给药2次。Seretide是沙美特罗（salmeterol）和氟替卡松（fluticasone）的复方药物，2者具有不同的作用机制，美沙特罗是一种选择性长效（12小时）β2-肾上腺素能激动剂（LABA），氟替卡松是一种吸入性糖皮质激素（ICS）。

Novartis' INSTEAD study for Onbrez® Breezhaler® in patients with moderate COPD meets primary objective

—Results confirm non-inferiority of Onbrez® Breezhaler® (indacaterol) in lung function compared to Seretide®* (salmeterol/fluticasone) in the studied population

—In INSTEAD study, patients with moderate COPD and no exacerbations in the past year were switched from salmeterol/fluticasone to Onbrez Breezhaler

—Study showed similar symptomatic benefits in terms of shortness of breath and health status in patients treated with Onbrez Breezhaler compared to those on salmeterol/fluticasone

Basel, April 25, 2014 - Novartis announced today top-line results from the Phase IV INSTEAD switch study in patients with chronic obstructive pulmonary disease (COPD), which met its primary objective. Once-daily Onbrez® Breezhaler® (indacaterol) 150 mcg demonstrated non-inferiority in lung function at week 12 to twice-daily Seretide®* (salmeterol/fluticasone propionate (SFC)) 50/500 mcg in patients with moderate COPD and no exacerbations in the previous year.

The INSTEAD switch study also showed similar symptomatic benefits in terms of shortness of breath and health status after 12 and 26 weeks in patients treated with Onbrez Breezhaler compared to those on SFC. The safety profile of Onbrez Breezhalerobserved in this study was consistent with previously reported results from Phase III studies.

"These positive results help inform the switch from salmeterol/fluticasone to Onbrez Breezhaler in patients with moderate COPD and who are at low risk of exacerbations. This confirms that Onbrez Breezhalerprovides an effective maintenance treatment option for these patients," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. "In addition, these results support international guidelines, which advise against the use of inhaled corticosteroids due to long-term risks in COPD patients at low risk of exacerbations[1]".

COPD affects an estimated 210 million people worldwide[2] and is projected to be the third leading cause of death by 2020[1]. Treatments that effectively control the symptoms of COPD and allow patients to continue with their daily activities are very important in helping address the unmet needs in the management of COPD[3],[4].

INSTEAD was a global, randomized, double-blind, parallel-group, 26-week study. This study randomized 581 patients with moderate COPD who had been taking SFC* for at least three months to either continue on SFC* or switch to indacaterol. The primary objective of this study was to demonstrate the non-inferiority of indacaterolversus SFC* in lung function (trough FEV1) after 12 weeks of treatment in patients with moderate COPD who had experienced no exacerbations in the previous year. Data from this study are expected to be presented at major medical congresses later this year.

About Onbrez Breezhaler
Onbrez Breezhaler (indacaterol) is a once-daily inhaled long-acting beta2-adrenergic agonist (LABA) that offers clinically relevant 24 hour bronchodilation combined with a rapid onset of action within five minutes at first dose, as demonstrated in the INERGIZE Phase III trial program[5]-[18]. Onbrez Breezhaler 150 mcg provided greater clinical benefit in terms of reduced shortness of breath, lower use of rescue medication and improved health status, compared with blinded tiotropium 18 mcg[16]. Onbrez Breezhalerwas first approved and launched in the EU (150 mcg and 300 mcg once-daily doses) for maintenance bronchodilator treatment of airflow obstruction in adult patients with COPD[19]. It has now received approvals in more than 100 countries around the world and is available in Japan (as OnbrezInhalation Capsules 150 mcg once-daily) and in the USA (as ArcaptaTM NeohalerTM 75 mcg once-daily).

About the Novartis COPD portfolio
Novartis is committed to addressing the unmet medical needs of COPD patients and improving their quality of life by providing innovative medicines and devices. The Novartis COPD portfolio includes Onbrez® Breezhaler® / Arcapta® Neohaler® (indacaterol), Seebri® Breezhaler® (glycopyrronium bromide) and Ultibro® Breezhaler® (indacaterol / glycopyrronium bromide), which are all indicated as maintenance treatments for COPD patients. Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei.

Novartis continues development of respiratory products for delivery via the low resistance Breezhaler® inhalation device, which makes it suitable for patients with different severities of airflow limitation[20]. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly[19],[20].

About COPD
COPD is a progressive life-threatening disease that makes it hard to breathe, with symptoms that have a destructive impact on patients' function and quality of life[1],[21]. COPD is often considered to be a disease of later years, but estimates suggest that 50% of those with COPD are now less than 65 years old, resulting in increases in absenteeism, premature retirement and reductions in workforce participation[3],[4].

*In some countries, Seretide®(salmeterol/fluticasone) 50/500 mcg is indicated for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (prebronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy. The patient population in the INSTEAD study who received salmeterol/fluticasone were moderate COPD patients who had not exacerbated twelve months prior to entry. The INSTEAD study used the Accuhaler® dry powder inhaler, also known as Diskus®. Seretide®, Diskus® and Accuhaler® are registered trademarks of the GlaxoSmithKline group of companies.