Formoterol Fumarate

5月2日，阿斯利康宣布固定剂量三联组合疗法Breztri Aerosphere（布地奈德+福莫特罗+格隆溴铵）在III期KALOS和LOGOS研究中达到所有主要终点，与吸入性糖皮质激素/长效 β2 受体激动剂（ICS/LABA）药物相比，该三联组合疗法在改善肺功能方面具有统计学意义和临床意义。Breztri包含吸入糖皮质激素布地奈德、长效抗胆碱能药物格隆溴铵、长效β2受体激动剂富马酸福莫特罗三种药物成分。该药已在中国、美国、欧洲和日本获批用于慢性阻塞性肺疾病（COPD）患者的维持治疗。KALOS和LOGOS研究是随机、双盲III期临床研究，旨在评估Breztri作为潜在哮喘治疗方法，对比维持ICS/LABA治疗在成人和青少年未控哮喘患者中的疗效和安全性。安全性方面，KALOS或LOGOS研究中未发现Breztri新的安全性或耐受性信号。两项III期研究的完整结果将在未来的医学会议上公布，并与监管机构共享。哮喘是一种常见的慢性呼吸道疾病，其特征是气道炎症和肌肉紧缩（支气管收缩），可能导致呼吸困难。全球有多达2.62亿人受哮喘影响，估计近一半接受双重疗法的患者仍未得到控制，这会显著限制肺功能并降低生活质量。阿斯利康生物制药研发执行副总裁Sharon Barr表示：“我们对KALOS和 LOGOS研究的结果感到兴奋，这些结果表明Breztri可能有助于改善全球数百万哮喘患者的生活。这些哮喘数据在Breztri于慢性阻塞性肺病（COPD）中的成熟应用基础上更进一步，我们期待与监管机构分享，以将这种重要药物带给更广泛的患者群体。”Copyright © 2025 PHARMCUBE. All Rights Reserved.欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

Positive high-level results from the Phase III KALOS and LOGOS trials in patients with uncontrolled asthma showed that AstraZeneca’s fixed-dose triple-combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) met all primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in lung function compared with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines. KALOS and LOGOS were replicate, randomised, double-blind trials designed to investigate Breztri as a potential treatment for asthma.1,2 The trials evaluated the efficacy and safety of Breztri versus maintenance treatment with ICS/LABA in adults and adolescents with uncontrolled asthma.1,2 Asthma is a common, chronic respiratory disease characterised by inflammation and muscle tightening in the airway (bronchoconstriction), which can make it difficult to breathe.3 As many as 262 million people worldwide are affected by asthma,3 and it is estimated that nearly half of those treated with dual therapy remain uncontrolled, which can significantly limit lung function and decrease quality of life.4,5 Alberto Papi, Professor and Chair of Respiratory Medicine at the University of Ferrara, and Director of the Respiratory Unit, CardioRespiratory Department, S. Anna University Hospital, Ferrara, Italy, and primary investigator, said: “Despite advancements in asthma treatments, millions of patients remain uncontrolled, which can cause frequent breathlessness, coughing and wheezing, significantly impacting their ability to perform daily activities. The results from the KALOS and LOGOS trials are exciting and demonstrate the potential of budesonide/glycopyrronium/formoterol to evolve the standard of care to more effectively treat asthma in a single inhaled triple therapy for patients who remain uncontrolled with dual maintenance therapy.” Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “We are excited by the positive results from the KALOS and LOGOS trials, which demonstrate that Breztri could help improve the lives of the millions of patients living with asthma. These asthma data build on the well-established profile of Breztri in COPD, and we look forward to sharing with regulatory authorities to bring this important medicine to a wider group of patients.” There were no new safety or tolerability signals identified for Breztri in KALOS or LOGOS. Full results from the two Phase III trials will be shared with regulatory authorities and presented at an upcoming medical meeting. Breztri is an inhaled triple-combination therapy approved for the treatment of chronic obstructive pulmonary disease (COPD) in adults in more than 80 countries worldwide including the US, EU, China and Japan. Notes Asthma Asthma is a prevalent, chronic respiratory disease affecting as many as 262 million people worldwide,3 including over 25 million in the US.6 When uncontrolled, inflammation and muscle tightening in the airway (bronchoconstriction) may cause wheezing, breathlessness, chest tightness, coughing, and even death.3,7 Many patients remain uncontrolled despite the availability of standard of care medicines and continue to experience significant limitations on lung function and reduced quality of life.4,5 KALOS and LOGOS Phase III trials KALOS and LOGOS are replicate confirmatory, randomised, double-blind, double-dummy, parallel group, multi-centre, 24-to-52-week variable length Phase III trials to assess the efficacy and safety of BGF (320/28.8/9.6μg and 320/14.4/9.6μg) compared with two fixed-dose, dual-combination therapies of budesonide, an ICS, and formoterol fumarate, a LABA: PT009 (in an Aerosphere inhaler) and Symbicort pressurised metered-dose inhaler (pMDI).1,2 KALOS and LOGOS included approximately 4,400 randomised patients. The trial design was optimised to evaluate the 320/28.8/9.6μg dose of BGF. The primary efficacy endpoints for the two individual trials were a change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24 and trough FEV1 over 12-24 weeks and over 24 weeks.1,2 In addition to the two registrational trials (KALOS and LOGOS),two qualifying trials, LITHOS and VATHOS, also met their primary endpoints.8,9 LITHOS and VATHOS included approximately 1,000 randomised patients. Breztri/Trixeo Aerosphere Budesonide/glycopyrronium/formoterol fumarate (BGF), approved under the brand name Breztri Aerosphere in Japan, China and the US, and Trixeo Aerosphere in the EU, is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a LABA, glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA), with budesonide, an ICS, and delivered via the Aerosphere pMDI. Breztri/Trixeo Aerosphere is approved to treat adults with COPD in more than 80 countries worldwide including the US, EU, China, Japan, and was prescribed to more than 5.5 million patients globally in 2024.10 AstraZeneca in Respiratory & Immunology Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company. 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. 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. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Matthew Bowden Company Secretary AstraZeneca PLC You are now leaving AstraZeneca.com You have selected a link that will take you to a site maintained by a third party who is solely responsible for its contents. AstraZeneca provides this link as a service to website visitors. 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