Budesonide/Formoterol Fumarate Dihydrate

患者是对疾病状态和药物治疗的直接感受者和体验者。在药物研发和决策的全过程中，应将患者视为主动参与者，将其对疾病和相关治疗的经验、观点、需求和偏好等患者体验数据，作为药物研发设计、实施的关键考虑要素，并纳入获益-风险评估体系，为符合患者需求的有价值的药物研发和上市提供科学证据。——《以患者为中心的药物临床试验设计技术指导原则》吸入药物：药械组合      吸入药物是呼吸系统疾病的首选剂型，是一种药械组合的产品，其使用的便利性、患者的偏好度和满意度，都对其临床疗效产生重要影响。现有研究显示，吸入药物是否容易操作、容易吸入和具有良好的反馈，是患者和医护群体首要关注的特征。Priority ranking of inhaler selection for (A) HCPs prescribing and (B) patients choosing (% of HCPs or patients selecting as highest priority for inhalerLough, Graham et al. Patient and Provider Perspectives Driving Inhaler ChoiceCHEST, Volume 166, Issue 5, 934 - 937吸入器是否容易操作两项针对不同年龄段和疾病状态患者群体的研究显示：容易操作（Easy Handling）和容易吸入（Inhalation Resistance/Duration）是影响患者对吸入器偏好度的首要特征。左右滑动查看更多然而，对于不同患者群体来说，是否“容易操作”是不同维度综合影响的结果，比如吸入器设计的复杂程度，其操作步骤多少，操作顺序是否符合患者一般习惯，以及临床教育的难易程度等等。左右滑动查看更多操作错误率研究，是不同吸入药物是否容易操作最直接的证据，有研究显示：相对于DPI（吸入粉雾剂）的药物来说，pMDI（喷雾剂）和SMI（软雾剂）的用药操作错误率较高，主要发生在药物吸入阶段，即呼吸协调性错误，对药物临床疗效的稳定性产生显著影响；不同DPI装置的操作错误率有显著差异。吸入药物是否容易吸入在产品设计中，不同DPI 吸入器具有不同的流阻；在临床实践中，患者的吸气能力各有不同。患者是否能够达到吸入药物设计的"最佳吸气流速"，往往直接影响该药物的临床疗效。左右滑动查看更多我们来看一个有趣的例子：以下研究采用布地奈德和福莫特罗的复方，在不同的吸入器下，研究患者用低、中、高吸气流速吸入后，药物递送剂量的分布。Comparison of two budesonide/formoterol DPIs 160/4.5 lg/dose, Easyhaler (a) and Turbuhaler (b) regarding the consistency of the delivered dose at different inhalation flow ratesLevy,Mark L. et,al. Understanding Dry Powder Inhalers: Key Technical and Patient Preference Attributes[J].Advances in therapy.2019, 36(10).显而易见，胶囊型吸入药物（A图）在不同吸气流速下，递送剂量更加稳定，提示较高的容错率，更稳定的临床疗效以及更广泛的患者适用群体。吸入器是否具有良好的反馈对患者来讲，吸入药物后最需要获得反馈是：（1）我的吸入方法是否正确？药物是否已经安全、足量地到达了起效部位？（2）手上的药物还剩下多少次的剂量？这些信息，对患者的依从性以及药物的临床疗效，有着重要的影响。左右滑动查看更多从目前已上市及研发管线的产品来看，设计者越来越多地认识到反馈的重要性，并尝试通过听觉、视觉、味觉、可靠的计数器或者更直观的数字化工具等，来提供更有效的反馈。然而，最经济、可靠、并获得最广泛认可的方式往往最简单、最直观。从这个角度来说，胶囊型吸入器，在视觉、听觉上的反馈方式最为简单直观，并获得了广泛的认可。患者是对疾病状态和药物治疗的直接感受者和体验者；但并不是所有的患者都有相同的偏好和需求。我们应当尝试理解患者需求中同质的部分，并科学的量化，进而将其尽早地纳入研发立项的决策中来，这是帮助我们开发更具临床价值的吸入药物的关键之一。关于杭州畅溪制药有限公司畅溪是一家处于临床阶段的创新型生物制药公司，核心业务聚焦于针对包括呼吸系统疾病在内，严重影响人类日常生活质量的疾病，发现、开发创新型药物，并实现其产业化。畅溪是由一群充满激情和富有业界经验的行业专家于2015年创立，公司的愿景是充分利用和发挥呼吸系统药物递送技术的优势和特点，为全球患者提供创新型治疗方案，真正改善患者生活质量。如需更多信息，请访问 www.chancepharmaceuticals.com点击阅读畅溪制药改良型新药CXG87吸入粉雾剂III期临床方案讨论会顺利召开畅溪制药改良型新药CXG87吸入粉雾剂获CDE许可进入III期临床试验

AstraZeneca's inhaler Breztri Aerosphere, which was approved for COPD in 2020, has taken a step toward a label expansion as it has aced two asthma trials. AstraZeneca has taken a key step in advancing Breztri Aerosphere toward a potential label expansion and achieving its goal of annual sales of $3 billion to $5 billion for the 3-in-1 inhaler.Two phase 3 trials evaluating the effectiveness and safety of Breztri in a total of 4,434 patients with uncontrolled asthma have met their primary endpoints. The studies showed that Breztri delivered statistically significant and clinically meaningful improvements in lung function compared to dual-drug combinations of inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA) maintenance treatments, AZ said.Data from the KALOS and LOGOS studies will be shared with regulatory authorities and presented at an upcoming medical meeting, the company added.Breztri Aerosphere, which was approved for chronic obstructive pulmonary disorder (COPD) in 2020, is a fixed-dose combination of the corticosteroid budesonide, the LABA formoterol fumarate and the long-acting muscarinic antagonist (LAMA) glycopyrronium.With sales (PDF) of $300 million in the first quarter of 2025, an increase of 37% year over year, Breztri is on its way to blockbuster status for the first time this year.A label expansion to treat asthma would open the treatment up to another large patient population. The condition affects roughly 262 million people around the world, AZ said, with nearly half of those treated with dual therapies remaining uncontrolled. “Despite advancements in asthma treatments, millions of patients remain uncontrolled, which can cause frequent breathlessness, coughing and wheezing,” Alberto Papi, of the St. Anna University Hospital in Ferrara, Italy, said in a press release. “The results from the KALOS and LOGOS trials are exciting and demonstrate the potential of Breztri to evolve the standard of care to more effectively treat asthma in a single inhaled triple therapy.”Breztri was developed as a combination of AZ’s blockbuster Symbicort (budesonide/formoterol), which was approved for asthma in 2006, and Bevespi (formoterol fumarate/glycopyrrolate), which was approved for COPD in 2016. In its development, Breztri has trailed GSK’s triple therapy Trelegy Ellipta, which was approved for COPD in 2017 and for asthma in 2020. Trelegy generated sales of $3.5 billion in 2024, an increase of 26%. GlobalData forecasts that sales of Breztri will reach $2.3 billion in 2030.Breztri is one of several treatments AZ is developing for respiratory diseases, including Fasenra and Amgen-partnered Tezspire. Both of those drugs have been approved to treat asthma and AZ is eying potential COPD label expansions. Fasenra achieved sales of $1.7 billion last year. AZ reported sales for fast-rising Tezspire, which was approved in 2021, at $684 million.