WILMINGTON, Del.--(BUSINESS WIRE)--Positive high-level results from the BATURA Phase IIIb trial showed AstraZeneca’s AIRSUPRA ® (albuterol/budesonide) met the primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk of a severe exacerbation when used as an as-needed rescue medication in response to symptoms compared to as-needed albuterol.1 The trial included patients with intermittent or mild persistent asthma, including those on short-acting beta2-agonist (SABA) alone, low-dose inhaled corticosteroid (ICS) maintenance therapy, or leukotriene receptor antagonist (LTRA) maintenance therapy..

威尔明顿，Del。--（商业新闻短讯）--巴图拉IIIb期试验的阳性高水平结果显示，阿斯利康的AIRSUPRA®（沙丁胺醇/布地奈德）达到了主要终点，表明与需要的沙丁胺醇相比，当用作对症状作出反应的必要救援药物时，严重恶化的风险具有统计学意义和临床意义。该试验包括间歇性或轻度持续性哮喘患者，包括单独使用短效β2受体激动剂（SABA），低剂量吸入皮质类固醇（ICS）维持治疗或白三烯受体拮抗剂（LTRA）维持治疗的患者。。

Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide,2 including over 25 million in the US.3 Patients with mild asthma comprise at least 50% of the US asthma population and are at risk of severe exacerbations.4,5

哮喘是一种慢性炎症性呼吸系统疾病，症状多样，影响全球2.62亿人，其中包括美国2500多万人。3轻度哮喘患者至少占美国哮喘人群的50%，有严重恶化的风险。4,5

James Donohue, Emeritus Professor of Pulmonary Medicine, University of North Carolina, and Chair, Independent Data Monitoring Committee, said: “People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control. By focusing on patients with intermittent or mild persistent asthma, the strong BATURA trial results further demonstrate the clinically meaningful benefit of an anti-inflammatory rescue approach to reduce the risk of severe exacerbations by treating both symptoms and inflammation at the same time.”.

北卡罗莱纳大学肺医学名誉教授、独立数据监测委员会主席詹姆斯·多诺霍（JamesDonohue）说：“哮喘患者无论疾病严重程度或控制程度如何，都有严重恶化的风险。通过关注间歇性或轻度持续性哮喘患者，strong BATURA试验结果进一步证明了抗炎救援方法的临床意义，通过同时治疗症状和炎症来降低严重恶化的风险。”。

Sharon Barr, Executive Vice-President, BioPharmaceuticals R&D, AstraZeneca, said: “The impressive BATURA trial results add to the body of evidence supporting AIRSUPRA as a first-in-class rescue treatment and its role in reducing the risk of asthma exacerbations in patients regardless of their disease severity, and reducing the need for systemic corticosteroids.”.

阿斯利康生物制药研发执行副总裁莎伦·巴尔（SharonBarr）表示：“令人印象深刻的巴图拉试验结果增加了支持AIRSUPRA作为一流救援治疗的证据，以及它在降低患者哮喘恶化风险方面的作用，无论其疾病严重程度如何，并减少对全身皮质类固醇的需求。”。

The safety and tolerability of AIRSUPRA in the BATURA trial was consistent with its established profile and no new safety concerns were reported. The data will be shared with health authorities and will be presented as a late-breaker oral presentation at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting on October 26 2024..

在巴图拉试验中，AIRSUPRA的安全性和耐受性与其既定的概况一致，没有新的安全问题报道。这些数据将与卫生部门共享，并将于2024年10月26日在美国过敏，哮喘与免疫学学院（ACAAI）年度科学会议上作为最新的口头报告提交。。

AIRSUPRA is the first and only anti-inflammatory rescue medication approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older.6 The US approval was based on results from the MANDALA and DENALI Phase III trials.7,8 AIRSUPRA is also being studied in adolescents with asthma (12 to <18 years old) in the ACADIA Phase III trial and in patients in China in the BAIYUN Phase III trial.9,10 AIRSUPRA is being developed by AstraZeneca and Avillion..

AIRSUPRA是美国批准的第一种也是唯一一种抗炎救援药物，用于根据需要治疗或预防支气管收缩，并降低18岁及以上哮喘患者恶化的风险。6美国的批准是基于MANDALA和DENALI III期试验的结果。7,8 AIRSUPRA也正在ACADIA III期试验中对哮喘青少年（12至18岁）和中国白云III期试验中的患者进行研究。9,10 AIRSUPRA正在由阿斯利康和Avillion开发。。

APPROVED USE

批准使用

AIRSUPRA combines 2 medicines to be used as needed as a rescue inhaler in people 18 years of age and older to:

AIRSUPRA结合了两种药物，可根据需要用作18岁及以上人群的救援吸入器，以：

treat or prevent symptoms of asthma

治疗或预防哮喘症状

help prevent sudden severe breathing problems (asthma attacks or exacerbations)

帮助预防突然出现的严重呼吸问题（哮喘发作或恶化）

IMPORTANT SAFETY INFORMATION

重要安全信息

Do not use AIRSUPRA if you are allergic to albuterol, budesonide, or any of the ingredients in AIRSUPRA

如果您对沙丁胺醇、布地奈德或艾苏普拉中的任何成分过敏，请不要使用艾苏普拉

Before using AIRSUPRA, tell your healthcare provider about all your medical conditions and about all the medicines you take

在使用AIRSUPRA之前，请告知您的医疗保健提供者您的所有医疗状况以及您服用的所有药物

A dose of AIRSUPRA is 2 inhalations (puffs) as needed. Use AIRSUPRA exactly as your healthcare provider tells you to use it. Do not use AIRSUPRA more than 12 puffs (which equals 6 doses) within a 24-hour period

根据需要，AIRSUPRA的剂量为2次吸入（抽吸）。按照医疗保健提供者的指示使用AIRSUPRA。在24小时内使用AIRSUPRA的次数不要超过12次（相当于6次剂量）

AIRSUPRA is not to be used as a maintenance treatment for asthma. If you are currently taking medicine long-term to maintain control of asthma symptoms, you should continue to take that medicine as directed by your healthcare provider

AIRSUPRA不可用作哮喘的维持治疗。如果您目前正在长期服用药物以维持哮喘症状的控制，您应该按照医疗保健提供者的指示继续服用该药物

Do not change or stop other inhaled medicines or asthma medicines (oral or inhaled) without first talking to your healthcare provider

未事先与您的医疗保健提供者交谈，请勿更换或停止其他吸入药物或哮喘药物（口服或吸入）

Call your healthcare provider or get emergency medical care right away if your breathing problems get worse, you need to use AIRSUPRA more often than usual, or AIRSUPRA does not work as well to relieve your asthma

如果你的呼吸问题恶化，你需要比平时更频繁地使用AIRSUPRA，或者AIRSUPRA不能很好地缓解你的哮喘，请立即致电你的医疗保健提供者或获得紧急医疗护理

AIRSUPRA can cause serious side effects, including:

AIRSUPRA可能会产生严重的副作用，包括：

worsening trouble breathing, coughing, and wheezing (paradoxical bronchospasm). If this happens, stop using AIRSUPRA and call your healthcare provider or get emergency medical care right away.

呼吸、咳嗽和喘息（反常的支气管痉挛）恶化。如果发生这种情况，请停止使用AIRSUPRA，并致电您的医疗保健提供者或立即获得紧急医疗护理。

This is more likely to happen with your first use of a new canister of medicine

这种情况更有可能发生在你第一次使用新的药物罐时

heart problems, including faster heart rate and higher blood pressure

心脏问题，包括心率加快和血压升高

possible death in people who use too much AIRSUPRA

使用过量AIRSUPRA的人可能死亡

serious allergic reactions. Tell your healthcare provider or get emergency medical care right away if you have a skin rash, redness, or swelling; severe itching; swelling of the face, mouth, or tongue; trouble breathing or swallowing; or chest pain

严重过敏反应。如果你有皮疹、发红或肿胀，请告诉你的医疗保健提供者或立即获得紧急医疗护理；严重瘙痒；面部、口腔或舌头肿胀；呼吸或吞咽困难；或胸痛

changes in laboratory blood levels. Low levels of potassium (hypokalemia) may cause abnormal heart rhythms

实验室血液水平的变化。低钾（低钾血症）可能导致心律异常

weakened immune system and increased chance of getting infections

免疫系统减弱，感染机会增加

fungal infection in your mouth and throat (thrush). This is a common side effect. Rinse your mouth with water, if available, without swallowing after using AIRSUPRA to help reduce your chance of getting thrush

口腔和喉咙的真菌感染（鹅口疮）。这是一种常见的副作用。如果可以的话，用清水漱口，使用AIRSUPRA后不要吞咽，以帮助减少鹅口疮的机会

reduced adrenal function (adrenal insufficiency). This can happen when you start taking a medicine containing an inhaled corticosteroid (such as AIRSUPRA)

肾上腺功能降低（肾上腺功能不全）。当你开始服用含有吸入性皮质类固醇的药物（如AIRSUPRA）时，就会发生这种情况

bone thinning or weakness (osteoporosis)

eye problems, including glaucoma and cataracts. Your healthcare provider may suggest having regular eye exams while using AIRSUPRA. Discuss any eye problems with your healthcare provider

眼部问题，包括青光眼和白内障。您的医疗保健提供者可能建议在使用AIRSUPRA时定期进行眼科检查。与您的医疗保健提供者讨论任何眼部问题

Common side effects include headache, cough, and hoarseness. These are not all the side effects of AIRSUPRA. For more information, ask your healthcare provider or pharmacist

常见的副作用包括头痛、咳嗽和声音嘶哑。这些并不是AIRSUPRA的全部副作用。有关更多信息，请咨询您的医疗保健提供者或药剂师

Please see full Prescribing Information and Patient Information and discuss with your doctor.

请查看完整的处方信息和患者信息，并与您的医生讨论。

You may report side effects related to AstraZeneca products.

您可能会报告与阿斯利康产品有关的副作用。

Notes

注释

Asthma

哮喘

Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide,2 including over 25 million in the US.3

哮喘是一种慢性炎症性呼吸系统疾病，症状多样，影响全球2.62亿人，其中包括美国2500多万人。3

Patients with asthma experience recurrent breathlessness and wheezing, which varies over time, and in severity and frequency.11 These patients are at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control.12,13 There are an estimated 136 million asthma exacerbations globally per year,14 including more than 10 million in the US;3 these are physically threatening and emotionally significant for many patients15 and can be fatal.2,16.

哮喘患者反复出现呼吸困难和喘息，随着时间的推移以及严重程度和频率的变化而变化[11]。这些患者无论其疾病严重程度，坚持治疗或控制水平如何，都有严重恶化的风险[12,13]。估计全球每年有1.36亿哮喘恶化，其中14例在美国超过1000万；。

Inflammation is central to both asthma symptoms12 and exacerbations.17 Many patients experiencing asthma symptoms use a SABA (e.g. albuterol) as a rescue medicine;18-20 however, taking a SABA alone does not address inflammation, leaving patients at risk of severe exacerbations,21 which can result in impaired quality of life,22 hospitalisation23 and frequent oral corticosteroid (OCS) use.23 Treatment of exacerbations with as few as 1-3 short courses of OCS are associated with an increased risk of adverse health conditions including type 2 diabetes, depression/anxiety, renal impairment, cataracts, cardiovascular disease, pneumonia and fracture.24 International recommendations from the Global Initiative for Asthma no longer recommend SABA alone as the preferred rescue therapy.11.

炎症是哮喘症状12和恶化的核心.17许多患有哮喘症状的患者使用SABA（例如沙丁胺醇）作为救援药物；18-20然而，单独服用SABA并不能解决炎症问题，使患者有严重恶化的风险[21]，这可能导致生活质量受损[22]，住院[23]和频繁使用口服皮质类固醇（OCS）[23]。治疗急性发作少至1-3个短期OCS疗程与不良健康状况的风险增加有关，包括2型糖尿病，抑郁/焦虑，肾功能不全，白内障，心血管疾病，肺炎和骨折[24]。全球哮喘倡议的国际建议不再推荐单独使用SABA作为首选的抢救疗法。

BATURA

发票

BATURA is a Phase IIIb, US, randomised, double-blind, parallel-group, event-driven trial, comparing the efficacy and safety of using inhaled albuterol/budesonide (180mcg/160mcg) as an as-needed rescue medication in response to symptoms compared to as-needed albuterol (180mcg) for up to 12 months. Patients recruited were aged 12 years and over with intermittent or mild persistent asthma and must have been using as-needed SABA alone, or as-needed SABA on a background of either low-dose ICS or LTRA maintenance therapy.25.

BATURA是一项美国IIIb期随机、双盲、平行组、事件驱动试验，比较使用吸入沙丁胺醇/布地奈德（180mcg/160mcg）作为针对症状的必要救援药物的疗效和安全性，与需要的沙丁胺醇（180mcg）相比长达12个月。招募的患者年龄在12岁及以上，患有间歇性或轻度持续性哮喘，必须根据需要单独使用SABA，或者在低剂量ICS或LTRA维持治疗的背景下根据需要使用SABA。

The primary efficacy endpoint was the time to first severe asthma exacerbation during the study period. Secondary endpoints included severe exacerbation rate and total systemic corticosteroid use.25

主要疗效终点是研究期间首次严重哮喘恶化的时间。次要终点包括严重恶化率和全身皮质类固醇使用总量

AIRSUPRA

AIRSUPRA

AIRSUPRA (albuterol/budesonide), formerly known as PT027, is a first-in-class SABA/ICS rescue treatment for asthma in the US, to be taken as needed. It is an inhaled, fixed-dose combination rescue medication containing albuterol (also known as salbutamol), a SABA, and budesonide, a corticosteroid, and has been developed in a pressurised metered-dose inhaler (pMDI) using AstraZeneca’s Aerosphere delivery technology.6.

AIRSUPRA（沙丁胺醇/布地奈德），原名PT027，是美国一流的SABA/ICS哮喘抢救治疗药物，可根据需要服用。它是一种吸入固定剂量的联合救援药物，含有沙丁胺醇（也称为沙丁胺醇），SABA和布地奈德（一种皮质类固醇），并已使用阿斯利康的大气层输送技术在压力计量吸入器（pMDI）中开发。

Outside of the US, AIRSUPRA is also approved in the United Arab Emirates, Kuwait, Bahrain, Qatar and Oman.

在美国之外，阿拉伯联合酋长国、科威特、巴林、卡塔尔和阿曼也批准了AIRSUPRA。

AstraZeneca’s Collaboration with Avillion

阿斯利康与Avillion的合作

In March 2018, AstraZeneca and Avillion signed an agreement to advance AIRSUPRA through a global clinical development program for the treatment of asthma. Under the terms of the agreement, Avillion became the trial sponsor responsible for executing and funding the global, multicentre, clinical trial program for AIRSUPRA through NDA filing to a regulatory decision in the US.

2018年3月，阿斯利康（AstraZeneca）和Avillion签署了一项协议，通过全球哮喘治疗临床开发计划推进AIRSUPRA。根据协议条款，Avillion成为试验赞助商，负责通过向美国监管决定提交NDA，执行和资助AIRSUPRA的全球多中心临床试验计划。

Following the successful approval of AIRSUPRA, AstraZeneca is commercializing the medicine. AstraZeneca extended its agreement with Avillion in 2022 to undertake the BATURA Phase IIIb trial to further assess the role of AIRSUPRA in reducing the risk of asthma exacerbations..

。阿斯利康于2022年延长了与Avillion的协议，以进行BATURA IIIb期试验，以进一步评估AIRSUPRA在降低哮喘恶化风险方面的作用。。

AstraZeneca in Respiratory & Immunology

阿斯利康呼吸与免疫学

Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company.

呼吸与免疫学是阿斯利康生物制药的一部分，是该公司的关键疾病领域和增长驱动力。

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets.

阿斯利康是呼吸系统护理领域的公认领导者，拥有50年的历史，并且在免疫介导疾病方面的药物组合不断增加。该公司致力于通过吸入药物、生物制剂和针对以前无法达到的生物目标的新模式的管道和组合，解决这些慢性病（通常使人衰弱）的巨大未满足需求。

Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases..

我们的目标是提供改变生命的药物，帮助消除COPD作为主要死亡原因，消除哮喘发作，并实现免疫介导疾病的临床缓解。。

AstraZeneca

阿斯利康

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 125 countries, and its innovative medicines are used by millions of patients worldwide.

阿斯利康是一家以科学为主导的全球生物制药公司，专注于肿瘤学、罕见病和生物制药（包括心血管、肾脏和代谢以及呼吸和免疫学）处方药的发现、开发和商业化。阿斯利康总部位于英国剑桥，在125多个国家开展业务，其创新药物被全球数百万患者使用。

For more information, please visit www.astrazeneca-us.com and follow us on social media @AstraZeneca..

欲了解更多信息，请访问www.astrazeneca-us.com，并在社交媒体@astrazeneca上关注我们。。

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