A Double-dummy, Double-blind, Randomized, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Compared to Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.

A double-dummy, double-blind, randomized, parallel-group, active controlled study to evaluate the efficacy and safety of QVM149 (indacaterol acetate / glycopyrronium bromide / mometasone furoate) compared to salmeterol xinafoate/fluticasone propionate in children from 12 years to less than 18 years of age with asthma.

开始日期2024-12-23

申办/合作机构

Novartis Pharmaceuticals Corp.

NCT05274425 / RecruitingN/A

A 24-week Prospective, Open-label, Multicenter, Single-arm, Observational Regulatory Post-Marketing Surveillance (rPMS) Study in Real-world Setting (Mandatory by Local HA Regulation) for Enerzair (QVM149 150/50/80 μg o.d. and QVM149 150/50/160 μg o.d. Via Breezhaler)

This surveillance was designed as a prospective, open-label, multicenter, single-arm, non-interventional, observational study to evaluate the safety and effectiveness of Enerzair inhalation capsule for up to 24 weeks under routine clinical practice.

开始日期2022-05-19

申办/合作机构

Novartis Pharmaceuticals Corp.

NCT05120986 / WithdrawnN/A

Sensor: ENhancing aSthma carE - An Observational Prospective Study to Characterize Patients Initiating Indacaterol + Glycopyrronium Bromide + Mometasone Furoate (Enerzair® Breezhaler®), With or Without Sensor, as a Maintenance Treatment for Asthma

This is an observational, descriptive, open-label, prospective, 6-month study including a group of patients with a first prescription of IND/GLY/MF with sensor and a group with a first prescription of IND/GLY/MF without sensor.

开始日期2022-02-15

申办/合作机构

Novartis Pharmaceuticals Corp.

100 项与醋酸茚达特罗/格隆溴铵/莫米松糠酸酯相关的临床结果

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100 项与醋酸茚达特罗/格隆溴铵/莫米松糠酸酯相关的转化医学

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100 项与醋酸茚达特罗/格隆溴铵/莫米松糠酸酯相关的专利（医药）

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项与醋酸茚达特罗/格隆溴铵/莫米松糠酸酯相关的文献（医药）

2023-06-29·Respiratory medicine

Efficacy of mometasone/indacaterol/glycopyrronium in patients with inadequately controlled asthma with respect to baseline eosinophil count: Post hoc analysis of IRIDIUM study.

Article

作者: Konstantinos Kostikas ; Jorge F Maspero ; Kenneth R Chapman ; Karen Mezzi ; Xavier Jaumont ; David Lawrence ; Richard van Zyl-Smit

BACKGROUND:

Baseline characteristics could potentially guide asthma treatments. We evaluated whether baseline eosinophil levels affect the efficacy of mometasone/indacaterol/glycopyrronium (MF/IND/GLY) in patients with inadequately controlled asthma.

METHOD:

In this post hoc analysis of IRIDIUM study, efficacy of high-dose MF/IND/GLY (160/150/50 μg, once-daily [o.d.]) versus high-dose MF/IND (320/150 μg o.d.) and high-dose fluticasone/salmeterol (FLU/SAL [500/50 μg, twice-daily [b.i.d.]); and efficacy of pooled MF/IND/GLY (160/150/50 μg and 80/150/50 μg) versus pooled MF/IND (320/150 μg and 160/150 μg) was evaluated in patient subgroups with baseline blood eosinophil count of <300 cells/μL or ≥300 cells/μL.

RESULTS:

Overall, 3065 patients were included. At Week 26, high-dose MF/IND/GLY showed improved trough FEV₁ versus high-dose MF/IND (Δ78mL [<300 cells/μL]; Δ54mL [≥300 cells/μL]) and FLU/SAL (Δ112mL [<300 cells/μL]; Δ98mL [≥300 cells/μL]). Similarly, pooled MF/IND/GLY also showed improved trough FEV₁ versus pooled MF/IND (Δ75mL [<300 cells/μL]; Δ68mL [≥300 cells/μL]). Over 52 weeks, high-dose MF/IND/GLY reduced the annualized rate of moderate or severe asthma exacerbations by 23% and 10%, severe exacerbations by 31% and 15%, and all exacerbation by 33% and 10% versus high-dose MF/IND for subgroups with <300 cells/uL and ≥300 cells/uL, respectively; and by 33% and 41%, 45% and 42%, 42% and 39% versus FLU/SAL, respectively. Similarly, pooled MF/IND/GLY reduced exacerbations by 22% and 8%, 21% and 7%, 27% and 8%, versus pooled MF/IND, for the respective subgroups.

CONCLUSION:

MF/IND/GLY showed improvement in lung function and reduction in asthma exacerbations over MF/IND and FLU/SAL independent of baseline eosinophil levels, indicating that eosinophil levels did not affect the efficacy of MF/IND/GLY in patients with inadequately controlled asthma.

TRIAL REGISTRATION:

ClinicalTrials.gov, NCT02571777 (IRIDIUM).

2022-11-26·Chest

Comparison of Clinical Outcomes among Different Fixed-dose Combinations of Long-acting Muscarinic Antagonists and Long-acting β₂-agonists (LAMA/LABA) in Patients with Chronic Obstructive Pulmonary Disease.

Article

作者: Ching-Fu Weng ; Chien-Chih Wu ; Mei-Hsuan Wu ; Fang-Ju Lin

BACKGROUND:

Researchers have yet to obtain conclusive evidence differentiating among fixed-dose combinations (FDCs) of long-acting muscarinic antagonists (LAMAs) and long-acting beta-agonists (LABAs) for chronic obstructive pulmonary disease (COPD) in terms of real-world clinical outcomes.

RESEARCH QUESTION:

What are the differences between available LAMA/LABA FDCs on the risk of acute exacerbation and cardiovascular events?

STUDY DESIGN AND METHODS:

This retrospective cohort study based on a national insurance claims database included COPD patients aged 40 and older who were newly prescribed glycopyrronium/indacaterol (GLY/IND), umeclidinium/vilanterol (UMEC/VI), or tiotropium/olodaterol (TIO/OLO) FDC between January 1, 2015, and June 30, 2019. Propensity score matching and Cox regression models were used to compare outcomes of acute exacerbation (AE) and cardiovascular events associated with LAMA/LABA FDC treatment.

RESULTS:

Among the 44,498 patients identified and included, 15,586 received GLY/IND, 20,460 received UMEC/VI, and 8,452 received TIO/OLO. Baseline characteristics were well balanced after 1:1 matching of UMEC/VI and GLY/IND, 2:1 matching of UMEC/VI and TIO/OLO, and 2:1 matching of GLY/IND and TIO/OLO. Risk of severe AE was lower among patients treated with UMEC/VI or GLY/IND than among those who received TIO/OLO (UMEC/VI vs. TIO/OLO: 17.85 vs. 29.32 per 100 person-years; hazard ratio [HR] 0.76, 95% confidence interval [CI] 0.68-0.84; GLY/IND vs. TIO/OLO: 15.54 vs. 25.53 per 100 person-years; HR 0.77, 95% CI 0.67-0.88). In addition, GLY/IND users tended to have a lower risk of cardiovascular events than TIO/OLO users, but the difference dissipated when restricting follow-up to a shorter duration.

INTERPRETATION:

Our results revealed that the risk of severe AE was lower among COPD patients receiving UMEC/VI or GLY/IND than among those receiving TIO/OLO, while the incidence of cardiovascular events was similar across groups but was slightly lower in GLY/IND users when compared with TIO/OLO users. Further research will be required to confirm these findings.

2022-03-29·The Journal of asthma : official journal of the Association for the Care of Asthma

Long-term safety of once-daily indacaterol acetate/glycopyrronium bromide/mometasone furoate high-dose, and indacaterol acetate/mometasone furoate high-dose, in Japanese patients with inadequately controlled asthma: Results from two open-label, 52-week studies.

Article

作者: Hironori Sagara ; Peter D'Andrea ; Ana-Maria Tanase ; Abhijit Pethe ; Yukina Tanaka ; Kazutaka Matsuo ; Motoi Hosoe ; Yoichi Nakamura

Introduction: The 52-week long-term safety of once-daily indacaterol acetate/glycopyrronium bromide/mometasone furoate (IND/GLY/MF) high-dose (150/50/160 µg) and IND/MF high-dose (150/320 µg) was evaluated in two studies enrolling Japanese patients with inadequately controlled asthma.Methods: Study 1 (IND/GLY/MF) and Study 2 (IND/MF) were 52-week, phase III, open-label, single-arm, multicenter studies conducted in Japanese adult patients with inadequately controlled asthma. The primary endpoint was incidence and severity of treatment-emergent adverse events (AEs) over 52-weeks.Results: In Study 1, 94 patients received IND/GLY/MF high-dose and 84 (89.4%) patients completed the 52-week study treatment; in Study 2, 51 patients received IND/MF high-dose and 48 (94.1%) patients completed the 52-week study treatment. In Study 1, 68.1% and 6.4% of 94 patients reported ≥1 AE and ≥1 serious AE (SAE) respectively. In Study 2, 78.4% of 51 patients reported ≥1 AE; no patients reported SAEs. The most commonly reported AEs were asthma (exacerbation; 30.9% and 54.9%) and nasopharyngitis (18.1% and 29.4%) in Study 1 and Study 2, respectively. Severe AEs including asthma (exacerbation) were reported in 13.8% and 13.7% of patients in Study 1 and Study 2, respectively. In Study 1, 10 patients (10.6%) reported treatment-related AEs, of which dysphonia (9 patients [9.6%]) was the most commonly reported; no treatment-related AEs were reported in Study 2. In Study 1, one death (not study drug-related) was reported after study discontinuation (92 days after last dose of study medication).Conclusions: Once-daily IND/GLY/MF and IND/MF high-dose were well-tolerated in Japanese patients with inadequately controlled asthma. No unexpected safety findings were observed.

项与醋酸茚达特罗/格隆溴铵/莫米松糠酸酯相关的新闻（医药）

2023-05-05

·动脉网

艾莱科劢德：瞄准亿级慢性呼吸系统疾病患者，打造吸入给药智能监测平台

或许，艾莱科劢德电子科技（以下简称为“艾莱科劢德”）创始人朱江保从来没有想到过，最终自己会进入到吸入给药智能监测领域。如今，已经是艾莱科劢德走过的第五个年头。对于朱江保来说，一切就像是在昨天发生的一样。但这家公司会发展成什么样子，或许早已在过去埋下“种子”，他在更早时已经看到了这家公司的未来。用互联网思维，做好慢病患者用药管理投身吸入给药智能监测领域，与艾莱科劢德创始人朱江保的个人经历有关。他身患慢性病的母亲，在身体状况较好时常常忘记服药。但是诸如高血压等慢性心脑血管疾病，由于用药不及时可能会导致脑出血等现象发生。为了避免这样的情况出现，他也曾做过很多努力，包括购买智能药盒帮助家中长者避免忘记用药。在一次医疗行业从业者的聚会上，朋友说到慢性呼吸系统疾病患者的现状给了他启发。他意识到，部分有着呼吸系统疾病的慢性病患者，其吸入给药效果往往依赖于患者用药时吸入流速和吸入持续时间。“如果可以监测吸入流速和吸入持续时间，精确记录当时用药姿态、用药情况，再和后期的预后效果相结合，可以给医生、患者、药企等带来比较大的价值。”慢性呼吸系统疾病患者的困境也让他联想到了自己的母亲，太过相似的困境，让朱江保想要解决这个问题，艾莱科劢德也就此诞生。实际上，这并非是一小部分群体面临的问题。当前，我国慢性患者数量在逐年增多，全国慢性病患者已超过3亿人。而以慢性呼吸系统疾病来看，罹患疾病人数也超亿人。慢性疾病给整个社会带来了巨大的疾病负担。而需求的增长，也进一步带来了包括慢病监测、慢病用药等细分市场规模的持续增长。“利用电子装置对患者的用药情况、用药效果进行监控，帮助用户形成良好的用药习惯，市场潜力巨大。”朱江保补充道，“当前，独生子女一代是照顾老年人的主力军，但是正在上班的中年人很难抽出时间照顾老人，用药监测等可以很好地协助中年人照顾年迈的父母。老人用药监测、慢性病用药监测一定会成为主流。”基于个人经历与对市场的洞悉，让朱江保一脚踏入了慢病管理用药监测领域。但是如何做？这是大多数人需要思考的第二个问题。对朱江保来说，此前的从业经历则很大程度决定了他如何做。在2006年毕业后，朱江保便投身到了产品研发等工作中，在消费电子制造领域、医疗领域、互联网、工业互联网领域有着多年的积淀。一方面，其曾经参与启信宝公司的组建、海致星图数据团队的组建，并在流式细胞监测全球排名第二的公司负责流式细胞仪产品的研发，有着丰富的产品开发经验。另一方面，他也曾先后参与多个APP开发工作，累积了大量的APP开发经验，具有很好的大数据管理经验，尤其是前端交互设计和开发、数据平台搭建、企业画像挖掘、客户需求挖掘、用户留存、数据挖掘清洗等细节方面都有很深入地探索。最终，他选择了用互联网思维，来实现患者的用药监测和管理。为了更好地达成这一目标，艾莱科劢德组建了一支熟悉医疗行业慢病管理、熟悉互联网的团队，包括诸如东南大学教授佟振博、原瑞士科莱恩医疗包装部门亚太区研发与项目总监任红贤等。此外，其还拥有两位具有20年经验的产品开发工程师。在团队组建完毕后，艾莱科劢德专注于呼吸领域的智能流速监测器与用药管理平台的建立，意图帮助更多医疗产品实现智能化升级，并通过电子流速监测器和网络APP平台来提高医疗装置的患者依从性和使用便捷性。打造吸入用药智能监测平台，适配多家药企产品针对部分慢性呼吸系统疾病患者，干粉吸入制剂患者往往用药依从性较低：很少有患者可以精准实现对吸入流速、吸入持续时间、吸入起始速度的精确把控。此外，大部分患者往往需要进行长期治疗。而这也进一步对药品的治疗效果和安全性提出了更高的要求。在老龄化日益严重的当下，如何帮助对应的老年慢性呼吸疾病患者更好地提升用药效果、提供用药提醒等服务显得愈加重要。从2018年12月成立开始，艾莱科劢德相继推出了各项产品：2019年9月推出舒利迭配套气流监测装置，2020年9月推出Handihaler配套气流监测装置，2021年3月推出Breezhaler配套气流监测装置，2022年6月推出基于声音的Handihaler监测装置。截至2022年底，艾莱科劢德完成了干粉吸入类电子装置基础开发。对于企业来说，如何实现盈利无疑是需要思考的点。而目前，艾莱科劢德将吸入给药智能监测平台免费提供给用户，除了帮助用户实现用药监测功能外，还可提供用药提醒等服务。与此同时，为了更好地实现患者依从性的提升，平台也允许将家人、医生纳入成员组实现患者用药监督。据悉，未来平台也不排除提供在线购药等增值服务。目前，艾莱科劢德的营利方式，主要是配合仿制药厂商（目前相关药品还未上市，部分企业处于仿制药阶段）缩短临床时间；同时配合医生对所开出的药品进行跟踪、做好用药效果的监测等。通过构建生态基础，在部分实现商业化的同时为后续商业化的推进进一步打好基础。据朱江保表示，未来艾莱科劢德也计划对接国外的原研药厂，以求在药品上市之初就可以搭配电子流速监测装置一块进行销售。目前，其与正大天晴、京卫制药等都在开展临床合作，协助这些仿制药企业进行他们的生物等效性试验；此外，其也在与浙江大学附属儿童医院合作，加速临床进展。市面上其实也有其他竞争者加入这一行业。但是对于艾莱科劢德来说，其独特的优势点有两个：一是可以实现监测吸入流速和吸入持续时间；二是针对市场上主流的吸入干粉给药器械做了对应的用药流速监测装置开发。从另一个侧面或许可以做些佐助说明。目前，艾莱科劢德围绕吸入式电子监测装置形成了多个专利。其中外观专利7个，新型发明专利2个。其主要围绕电子流速监测和声音监测两个领域展开，同时其气雾式专利也在进行布局中、将逐步形成慢性肺阻塞吸入给药监测领域的专利覆盖。据悉，艾莱科劢德也计划进一步补齐产品线，改变目前仅有干粉吸入式电子装置的局面，“下一步我们会补齐压力气雾剂类呼吸药的电子装置，做全慢性呼吸全系列用药过程电子监控装置。同时，我们将把我们现有的装置推进到临床阶段并进行医疗认证。此外，通过提供语音等低成本的解决方案，我们将形成通用化和高性价比的产品。我们也在进一步研发注射笔等电子监测装置等。”目前，艾莱科劢德也计划进一步推进融资，推动新产品的开发和技术的升级，进一步提高公司的竞争力，补齐产品线；并通过扩充研发团队，达到跨越式发展，加速推进临床试验及产品获批。“哮喘患者和慢阻肺患者正确地使用吸入给药器械面临很大的负担。中国的医生每天接诊量巨大，很多患者都无法得到良好的用药教育，吸入疗效要远远差于欧美的患者。我们希望通过我们的给药装置、用药监测平台，帮助患者实现更好的疾病管理效果。”朱江保提到。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

2022-06-07

·CPhI制药在线

给药 | 吸入制剂中的递送装置创新

{关注并星标 CPhI制药在线} 吸入制剂是指利用吸入装置将药物递送进入呼吸道发挥局部或全身治疗作用的制剂。吸入装置是吸入制剂中的药物递送工具，对药物在肺部递送效率和治疗效果具有重要的影响。有效的药物递送装置能在期望的治疗靶点递送最佳剂量的药物。要获得最佳的肺部沉积，需要先进的装置和最佳的配方。药物制剂和给药装置还需要优化协调，以获得能实现特定靶向沉积的效果。目前，新型药物递送装置的开发正在引起潜在研究者和生产企业的重视。 1. 吸入装置的起源吸入疗法最早可以追溯到4000多年前，人们使用罐子或者烟管等加热药物产生烟雾或蒸汽以供吸入，用以治疗哮喘等疾病。而到1956年3月，Riker Laboratories（现3M制药公司）将氟利昂（CFC）12和CFC14的混合物作为抛射剂，与异丙肾上腺素或肾上腺素填充于耐压喷雾装置Medihaler中，利用抛射剂气化将药物分散为气溶胶以供吸入，开创了药物配方联合吸入装置的药械组合式pMDI吸入制剂，该装置的诞生也成为了吸入药物开发的一个里程碑事件。 2. 吸入装置的创新 2.1 压力定量吸入气雾剂（pMDI） pMDI是一种主动吸入给药装置，其抛射剂为气雾产生的能量来源，药物输出受吸气流速的影响较小，目前是全球吸入给药中使用最广泛的剂型。针对使用过程存在需要患者手口协调性好和递送剂量不准确等问题，制药企业在新产品中推出改良的pMDI和呼吸驱动的pMDI作为解决方案。吸入装置的改良主要包括：研发非预装阀门以解决传统预装阀门的装量损失和剂量波动问题，改进垫圈材料降低对配方成分的吸附，应用罐体氟碳涂层材料和气体等离子涂层技术降低罐体和配方之间的相互作用，优化激发器喷嘴直径和形状、吸嘴外形以减少气溶胶在咽喉的沉积等。呼吸驱动型pMDI能通过呼吸触发罐体的响应机制喷出气溶胶。3M制药公司推出了呼吸驱动pMDI-Maxair Autohaler，患者仅需达到30L/min的吸气流速，即可触发罐体的响应机制而喷出气溶胶。TAVA制药公司生产的Easi-Breathe inhaler为无CFC的呼吸驱动pMDI，适用于成人、青少年和4岁以下婴幼儿。相较于传统pMDI和DPI吸入装置，呼吸驱动型pMDI能缓解手口协调问题，更受患者欢迎。 2.2 干粉吸入装置（DPI） DPI作为一种被动吸入装置，不含抛射剂，它由药物颗粒和/或与载体混合组成，贮存于胶囊、泡囊或多剂量储库中，通过患者主动吸气与装置内部阻力产生的湍流将药物转化为气溶胶，吸入肺部达到治疗作用。DPI的改进主要体现在进一步简化操作步骤，改善装置的易操作性，降低吸气峰流速要求，提高剂量均一性，增加吸入反馈功能等。葛兰素史克研发的Ellipta仅有开-吸-关3个步骤，吸入装置操作简单，患者接受度更高，并且患者的吸气流速在30~90L/min范围内，激发药量可控制在87.6%~96.9%，细颗粒占比控制在20.7%~25.4%，剂量均一性较好，目前使用Ellipta的双支扩吸入剂已经在国内上市。意大利凯西公司研发的NEX Thaler，除吸气峰流速要求低、剂量均一性高外，还具有一个新颖的全剂量反馈系统，在全剂量被吸出后，装置会发出提示声音，同时剂量计数器减少一个计数。MEDA制药公司研发的Novolizer有一个可视化、声音和味觉提示的吸入反馈系统，当吸气流速达到35L/min的阈值后，药物即可从装置中释放，形成气溶胶，此时指示窗颜色变化，发出提示音，患者尝到乳糖的甜味，这些都可以提醒患者正确地完成了一次药物吸入。 2.3 软雾吸入装置（SMI）软雾吸入装置是一种的新型吸入制剂，一方面通过旋转底座的压缩弹簧所产生的机械能为动力，为药物释放气溶胶提供能量，另一方面通过毛细管精准定量和独特的两束药液射流对撞原理，以特定角度撞击形成独特“软雾”。德国勃林格殷格翰公司开发的软雾装置Respimat于2004年在德国批准上市，它综合了pMDI和雾化器的优点。Respimat采用一种小型、便携式手持装置，无需电源就可使无抛射剂的药物溶液通过雾化器缓慢雾化成软雾，减少患者吸入时药物在口咽部的沉积。相对于传统的pMDI和DPI，Respimat可显著提高药物的肺部沉积率，从而减少药物的治疗剂量。然而，由于SMI在首次使用前需进行一些基本的组装和启动，而且价格较其他的吸入装置更高，此外，目前SMI尚无含吸入性糖皮质激素的药物，以上的诸多因素也限制了SMI在临床上广泛应用，但不阻碍其成为今后吸入装置研制与发展的热点。 2.4 新型高效递送装置 Aeroneb是爱尔兰Aerogen公司研发的一系列新型高效便携的雾化吸入给药装置，可用于自主呼吸和呼吸机依赖者。Aeroneb®Go是小型便携手持式雾化器，Aeroneb®Solo通过有创或非侵入式进行气溶胶输送，Aeroneb®NIVO是与荷兰Philips Healthcare公司联合开发的专用无创机械通气气溶胶输送装置。这些装置均具有组装方便、操作静音、雾化治疗时间短、容易清洁等特点。eFlow装置采用英国ODEM公司的TouchSpray雾化头，包含带有4000个激光钻孔的薄膜，周围是一个压电驱动器，可产生气溶胶，是一种电池驱动、紧凑、便携式雾化器，雾化效率高、雾化时间短，能提高患者的依从性。 2.5智能吸入装置智能吸入装置利用电子监控系统与互联网或其他设备相连接，通过外接或自身整合方式，提高患者的用药依从性，减少因设备或患者操作造成的服药错误。美国Propeller Health公司开发了一套具有综合监控和反馈功能的外接智能系统，能记录患者的用药信息，实现医患间数据共享，以便于医生及时调整治疗方案。该系统于2012年经FDA批准上市，适用于诺华公司生产的Breezhaler，勃林格殷格翰公司生产的Respimat，葛兰素史克公司生产的Diskus和Ellipta等DPI装置。新西兰Adherium公司研发的外接式Hailie吸入药物智能管理器也于2014年经FDA批准上市，除具有提醒、记录、管理等功能外，还可将信息上传到手机,适用于葛兰素史克公司生产的Ventolin、阿斯利康公司生产的Turbuhaler等装置，并可通过蓝牙将信息传送至手机。荷兰Philips Respironics公司研发的自身集成式智能雾化器采用自适应雾化输送（AAD）技术，通过分析患者的呼吸模式，确定雾化药物在吸入过程中的雾化传输时间。 3M公司于2016年推出的Intelligent Control Inhaler吸入装置，操作简便（打开-吸入-关闭三步），并具有呼吸驱动功能，患者不需要接受技术培训，通过屏幕提示和吸气流速控制即可完成吸入过程，降低了患者吸入操作和吸气曲线的变异度。同时，该设备还具有记录和管理功能，可将患者使用吸入药物的信息远程传递给医务人员。结语吸入装置通过不同的气溶胶发生原理，结合相应的药物形态形成了现有的药械组合式吸入制剂，是目前防治哮喘、慢性阻塞性肺疾病等呼吸道疾病的首选。但在临床使用过程中传统吸入装置也逐渐暴露出一些问题，新型吸入装置致力于通过装置性能的创新弥补吸入装置目前存在的缺点，并结合智能化和云端管理扩展功能等，提高患者的使用依从性，从而进一步提高临床治疗效果。参考文献： [1]何明欣,周向东,徐立,张娜,周明,骆丁,张华,李琪.呼吸道吸入药物递送系统的研究进展[J/OL].海南医学院学报:1-9[2022-06-03].DOI:10.13210/j.cnki.jhmu.20220506.002. [2]鲁成浩,刘阿利,王庆娟,冯中,张贵民.经口吸入制剂的研究进展[J].中国医药工业杂志,2022,53(02):175-183. [3]张玮,丁楠,曹兆流,舒萍,高申,王卓.吸入装置的演变过程及研究进展[J].药学服务与研究,2021,21(01):52-56. 作者简介：沙罗，中药研发工作者，现就职于国内某大型药物研发公司，致力于中药新药的研究开发。{ 推荐阅读 }智药研习社6月线上培训会报名来源：CPhI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多精彩制药资讯，请关注CPhI制药在线▼点击阅读原文，进入智药研习社~

2021-09-03

·BioSpace

Novartis Scuttles Kidney Transplant Drug Study

Harold Cunningham/Getty Images Novartis announced that after conducting an interim analysis from its CIRRUS-1 trial of CFZ533 (iscalimab), it is discontinuing the trial in kidney transplant patients. The drug is dosed with tacrolimus and other immunosuppressive therapies to prevent organ rejection. The company indicated the drug would continue to be developed to treat hidradenitis suppurativa and Sjögen’s syndrome and other autoimmune diseases. It is currently being evaluated in the Phase II CONTRAIL trial in liver transplant patients and other studies in type 1 diabetes and lupus nephritis. The study data apparently indicated that iscalimab was not as effective as tacrolimus at preventing organ rejection in kidney transplant patients when both were added to standard immunosuppressive therapies. Those therapies included drugs such as mycophenolate mofetil and corticosteroids. Earlier studies suggested iscalimab might be more effective than tacrolimus. In those studies, patients had kidney biopsies as healthy as normal kidneys about one year after transplant. Studies show that less than 50% of donated kidneys last 10 years. Any therapy that can extend the life of donated kidneys would have a significant impact on patients and donor organ availability. Worldwide, there are approximately 3.2 million people with end-stage renal disease. The CIRRUS-1 trial evaluated 418 transplant patients and studied three different doses of iscalimab. The drug is a fully human antibody that targets the CD40 antigen. It is engineered to inhibit immune reactions to foreign transplanted tissue. The study was expected to run to at least 2023. Novartis also announced that it is presenting abstracts at the upcoming European Respiratory Society (ERS) International Congress 2021 from September 5 to 8 on its 12 Enerzair Breezhaler and Atectura Breezhaler. The data continues to support the efficacy of Enerzair Breezher, and there will also be an interim analysis of patient engagement and adherence levels of the Enerzair Breezhaler’s optional digital companion. “Our presence at ERS this year reiterates our commitment to patients through the further development of first-in-class therapies like Enerzair Breezhaler, as well as by exploring the potential of digital health companions and the carbon footprint of our solutions,” said Dominic Brittain, Respiratory Global Program Head, Novartis Pharmaceuticals. “As a global leader in respiratory and allergy, we remain committed to reimagining medicine for patients living with chronic respiratory diseases like asthma.” And on September 1, Novartis inked a commercial agreement with the National Health Service (NHS) in England as part of a collaboration to develop a population health management approach for high cholesterol levels in patients with atherosclerotic cardiovascular disease (ASCVD). This deal comes after a positive final recommendation from the National Institute for Health and Care Excellence (NICE) for using inclisiran in primary care for adults for its licensed indication. It is licensed in Europe for adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, in addition to diet modification. “High cholesterol is a major cause of cardiovascular disease—disease of the heart and blood vessels,” said Jules Payne, chief executive at HEART UK, the cholesterol charity. “It is very common and can affect anyone including those who are young, slim, fit and active. HEART UK looks forward to continuing our leading role in helping people effectively manage their cholesterol and we warmly welcome the collaboration between Novartis and the NHS to enable more people to access this innovative medicine.”

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02571777 (CTgov)	临床3期	哮喘	3,092	QVM149 150/50/160 (QVM149 150/50/160 µg o.d.)	(壓繭糧築觸製鬱膚範淵) = 鹽觸艱簾膚膚鬱構襯廠衊壓簾衊獵繭範鹽憲窪 (鏇襯鬱獵廠鑰齋壓觸觸, 範鏇簾鹽夢廠繭襯選鬱 ~ 簾醖鹹衊簾蓋夢構範獵) 更多	-	2020-07-22
				QVM149 150/50/80 (QVM149 150/50/80 µg o.d.)	(壓繭糧築觸製鬱膚範淵) = 壓積顧襯壓餘蓋壓憲餘衊壓簾衊獵繭範鹽憲窪 (鏇襯鬱獵廠鑰齋壓觸觸, 顧築鬱遞淵鏇鑰構範壓 ~ 顧獵夢獵餘蓋壓獵積範) 更多
ERS2011	N/A	慢性阻塞性肺疾病	208	Tiotropium	繭膚獵積膚鹹鹹蓋蓋淵(構窪網壓齋壓簾餘繭願) = 網餘鏇衊鏇築憲鑰齋蓋憲鏇獵齋餘遞窪鏇顧襯 (遞鏇廠齋願蓋網淵齋膚 )	-	2011-09-01
				Salmeterol/Fluticasone	繭膚獵積膚鹹鹹蓋蓋淵(構窪網壓齋壓簾餘繭願) = 範齋蓋鬱窪製繭醖膚鹽憲鏇獵齋餘遞窪鏇顧襯 (遞鏇廠齋願蓋網淵齋膚 )
ERS2019	N/A	-	10	salmeterol/fluticasone	範糧網鏇鹽鏇築餘餘窪(憲築範衊觸鬱範夢顧齋) = 鹽觸鬱夢衊糧鏇廠簾鏇製齋憲願積鑰遞襯繭繭 (衊壓簾獵簾鹹餘壓鑰網 )	积极	2019-09-28
				salmeterol/fluticasone	範糧網鏇鹽鏇築餘餘窪(憲築範衊觸鬱範夢顧齋) = 襯膚網願鬱蓋襯糧鏇顧製齋憲願積鑰遞襯繭繭 (衊壓簾獵簾鹹餘壓鑰網 )
NCT03158311 (CTgov)	临床3期	哮喘	1,426	QVM149 (QVM149 150/50/80 μg)	鬱顧壓繭構鑰淵齋繭衊(膚簾醖鏇鑰鹽鏇餘淵夢) = 築鹽膚觸廠鏇憲築蓋蓋鑰構簾構鏇鏇醖獵構願 (憲襯壓憲構製製積餘壓, 網淵艱襯鏇顧齋顧醖積 ~ 齋積壓顧範齋遞齋範夢) 更多	-	2020-10-14
				QVM149 (QVM149 150/50/160 μg)	鬱顧壓繭構鑰淵齋繭衊(膚簾醖鏇鑰鹽鏇餘淵夢) = 壓製鹽遞觸憲憲觸蓋遞鑰構簾構鏇鏇醖獵構願 (憲襯壓憲構製製積餘壓, 鏇襯鑰蓋獵繭廠糧醖鹹 ~ 餘鹹齋獵醖遞艱糧願鹽) 更多
NCT03100825 (CTgov)	临床3期	哮喘	96	QVM149	(鑰廠鑰餘觸糧鹽醖糧夢) = 夢壓膚鏇齋艱艱齋簾範簾網憲壓觸鹽蓋鏇觸構 (獵築簾構憲蓋齋衊簾壓, 齋淵觸築網繭範夢獵廠 ~ 選鹽繭繭衊繭夢衊窪製) 更多	-	2020-04-07
NCT03108027 (CTgov)	临床2期	哮喘	38	placebo+glycopyrronium bromide+indacaterol acetate+QVM149 (QVM149 am)	膚顧艱艱鑰鏇衊繭鏇鬱(鹽顧範範壓願積積製齋) = 衊膚壓獵餘顧艱鹽襯鬱淵遞觸壓醖遞齋醖選鬱 (積淵餘網壓選網獵醖積, 廠艱鏇製壓觸遞糧餘網 ~ 廠醖襯範網製窪齋網觸) 更多	-	2019-05-21
				indacaterol acetate150+glycopyrronium bromide+QVM149 (QVM149 pm)	膚顧艱艱鑰鏇衊繭鏇鬱(鹽顧範範壓願積積製齋) = 構築餘願蓋鏇淵膚齋積淵遞觸壓醖遞齋醖選鬱 (積淵餘網壓選網獵醖積, 齋願醖鹽築衊繭願觸醖 ~ 築觸蓋顧齋餘衊鹽齋淵) 更多
NCT02571777 (IRIDIUM, Pubmed)	临床3期	-	1,930	Medium-dose MF/IND/GLY	(齋鹹製積鏇餘壓顧鏇壓) = 構餘製齋淵餘醖觸簾醖築憲壓選獵構鹽襯鹹衊 (獵糧簾遞獵積鬱衊積鬱, -7 ~ 90)	积极	2023-08-01