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.

BATURA IIIb 期试验的积极高水平结果表明，阿斯利康的Airsupra（沙丁胺醇/布地奈德）达到了主要终点，与按需使用沙丁胺醇相比，在用作应对症状的按需救援药物时，严重恶化的风险具有统计学和临床​​意义的降低。1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-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

哮喘是一种慢性炎症性呼吸道疾病，症状各异，影响着全球多达 2.62 亿人，2其中包括超过 2500 万人在美国。3轻度哮喘患者占美国哮喘人口的至少 50%，并且有严重恶化的风险。

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.”

北卡罗来纳大学肺科名誉教授、独立数据监测委员会主席 James Donohue 表示：“无论哮喘患者的病情严重程度或控制程度如何，他们都面临严重恶化的风险。通过专注于间歇性或轻度持续性哮喘患者，BATURA 试验的强劲结果进一步证明了抗炎救援方法具有临床意义，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部执行副总裁 Sharon Barr 表示：“令人印象深刻的 BATURA 试验结果进一步证明Airsupra是一流的救援治疗药物，并且能够降低患者（无论其病情严重程度如何）哮喘发作的风险，并减少对全身性皮质类固醇的需求。”

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 26 October 2024

Airsupra在 BATURA 试验中的安全性和耐受性与其既定概况一致，没有报告新的安全问题。这些数据将与卫生当局共享，并将在 2024 年 10 月 26 日举行的美国过敏、哮喘和免疫学学院 (ACAAI) 年度科学会议上作为最新口头报告进行介绍。

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是美国首个也是唯一一个获批的抗炎急救药物，用于按需治疗或预防支气管收缩，并降低 18 岁及以上哮喘患者的病情恶化风险。6美国的批准是基于MANDALA 和 DENALI III 期试验的结果。7,8 Airsupra还在 ACADIA III 期试验中针对青少年哮喘患者（12 至 <18 岁）进行研究，并在 BAIYUN III 期试验中针对中国患者进行研究。9,10 Airsupra由阿斯利康和 Avillion 共同开发。