Post-marketing Phase IV, Multicenter, Prospective Study to Observe the Safety and Tolerability of Breztri aerosphereTM Containing a Fixed Dose Combination of Budesonide 160 mcg/ Glycopyrronium 7.2 mcg/ Formoterol Fumarate Dehydrate 5 mcg in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The purpose of this study is to observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD.

开始日期2025-07-30

申办/合作机构

AstraZeneca PLC

NCT06712563

/ RecruitingN/A

Pooled Analysis of Multi-country, Open-label Single-arm, Non-interventional, Multi-center, Cohort Studies of Real-world Outcomes in New Users of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting

The CHOROS pooled analysis is a retrospective secondary data use analysis of integrated individual participant data from a series of planned and on-going primary prospective, non-interventional, multi-center studies sponsored by AstraZeneca and conducted in the pulmonary/primary care practitioner setting in multiple countries and may include data from the following countries: United Kingdom, Germany, Italy, Greece, Japan, Canada and Romania.

开始日期2025-04-17

申办/合作机构

AstraZeneca PLC

NCT06905483

/ Recruiting临床4期IIT

Comparative Effects of Triple Inhaled Therapy With Budesonide/Glycopyrronium/Formoterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol on Small Airway Disease in COPD Patients: A Randomized Crossover Study

The goal of this clinical trial is to determine if triple inhaled therapy with Budesonide/Glycopyrronium/Formoterol (BGF) and Fluticasone Furoate/Umeclidinium/Vilanterol (FUV) are effective in treating patients with stable chronic obstructive pulmonary disease (COPD). It will also assess the safety of both drugs.
The main questions it aims to answer are:
* Does BGF demonstrate a comparable effect to FUV in COPD participants?
* What medical problems do participants experience when taking BGFand FUV?

开始日期2025-04-01

申办/合作机构

Thammasat University

100 项与布地格福相关的临床结果

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100 项与布地格福相关的转化医学

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100 项与布地格福相关的专利（医药）

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项与布地格福相关的文献（医药）

2025-09-01·Respiratory Investigation

Real-world effectiveness of budesonide/glycopyrronium/formoterol fumarate metered dose inhaler on symptoms and quality of life in patients with COPD: EBISU study

Article

作者: Kawayama, Tomotaka ; Nishida, Kenichiro ; Kato, Yuki ; Yoshida, Yuri ; Hirai, Takehiro ; Sugiura, Hisatoshi ; Makita, Naoyuki ; Muro, Shigeo ; Hozawa, Soichiro

BACKGROUND:

There are limited real-world data regarding triple therapy with inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β₂-agonist on symptoms and patient-reported outcomes (PROs) in patients with chronic obstructive pulmonary disease (COPD), without current/history of asthma. We investigated the effects of budesonide/glycopyrronium/formoterol fumarate (BGF) metered dose inhaler (MDI) triple therapy on health status and PROs in patients with COPD in daily clinical practice.

METHODS:

This was a 12-week, prospective, multicenter, observational study (NCT05219630). The primary endpoint was mean change from baseline in the COPD Assessment Test (CAT) over 12 weeks. Secondary and exploratory endpoints included mean change from baseline in the St George's Respiratory Questionnaire (SGRQ) over 12 weeks and CAT score subgroup analyses.

RESULTS:

In total, 102 patients were analyzed; mean age at baseline was 73.8 years, mean forced expiratory volume in 1 s was 57.7 %, CAT total score was 15.6, and SGRQ score was 33.3. The adjusted mean change from baseline over 12 weeks in CAT was -2.9 (standard error [SE] 0.5) (P < 0.001), and in SGRQ was -2.7 (SE 0.9) (P = 0.004). As early as Week 4, these scores were significantly improved from baseline. In subgroup analyses, CAT scores were improved, regardless of blood eosinophil counts at baseline and exacerbation history in the previous year.

CONCLUSIONS:

Triple therapy with a BGF MDI significantly improved CAT and SGRQ scores over 12 weeks. BGF MDI could be a suitable option for patients living with COPD who have persistent symptoms without current asthma or a history of asthma.

TRIAL REGISTRATION:

ClinicalTrials.gov (NCT05219630).

2025-04-01·Translational Lung Cancer Research

Budesonide/glycopyrronium/formoterol fumarate co-suspension metered dose inhaler relieves cough after lobectomy: a randomized controlled study

Article

作者: He, Miao ; Lao, Shen ; Hao, Zhexue ; Xie, Zixian ; Xv, Xin ; Cui, Fei ; Jiang, Shunjun ; Liang, Hengrui ; He, Jianxing ; Zhang, Man ; Li, Jingpei ; Qiu, Yuan ; Huang, Jun ; Dong, Junguo ; He, Huanghe ; Wang, Wei ; Zhang, Yuan

Background:

Cough after pulmonary resection (CAP) has emerged as a prevalent complication. However, existing treatment protocols for CAP lack standardization. The components of the budesonide/glycopyrronium/formoterol fumarate co-suspension metered dose inhaler (BGF MDI) have been consistently documented for their effectiveness in cough management. Consequently, we initiated this clinical trial to evaluate the efficacy and safety of BGF MDI in mitigating CAP.

Methods:

Enrolled participants exhibited no pre-existing cough before undergoing lobectomy. The patients were randomly assigned in a 1:1 ratio to either the BGF MDI group or the Control group. The BGF MDI group received BGF MDI for 14 consecutive days postoperatively; each participant in both groups underwent continuous follow-up for 60 days. Cough severity, duration, and cough-related quality of life were evaluated. The primary endpoints were focused on the occurrence of obvious CAP lasting ≥14 days.

Results:

Finally, 51 patients in the BGF MDI group and 52 patients in the Control group were included in the analysis after accounting for dropout. The BGF MDI group demonstrated a reduction in the incidence of obvious CAP lasting ≥14 days (13.7% vs. 40.4%). The cough-related quality of life for the BGF MDI group on the 14th and 30th days after surgery was higher. Three participants in the BGF MDI group reported palpitations, with no other complications noted.

Conclusions:

BGF MDI has shown efficacy and safety in reducing CAP severity and duration. Using BGF MDI after lobectomy helps to alleviate cough symptoms and speed up postoperative recovery.

Trial Registration:

Clinicaltrials.gov. Clinical Trial Registry Number: NCT05472350.

2025-04-01·AMERICAN JOURNAL OF MEDICINE

Effectiveness of Single Versus Multiple Inhaler Triple Therapy on Mortality and Cardiopulmonary Risk Reduction in COPD: The SKOPOS-MAZI Study

Article

作者: Müllerová, Hana ; Vogelmeier, Claus F. ; Hawkins, Nathaniel M ; Rhodes, Kirsty ; Vogelmeier, Claus F ; Marshall, Jonathan ; Pollack, Michael ; Hawkins, Nathaniel M. ; Anzueto, Antonio ; Rapsomaniki, Eleni

BACKGROUND:

Patients with chronic obstructive pulmonary disease (COPD) have elevated cardiopulmonary and mortality risk, particularly following exacerbations. While single inhaler triple therapies (SITTs), such as budesonide/glycopyrrolate/formoterol fumarate (BGF), reduce cardiopulmonary risk versus dual bronchodilator therapy, there is limited evidence comparing outcomes with SITTs versus multiple inhaler triple therapies (MITTs).

METHODS:

SKOPOS-MAZI was a retrospective comparative effectiveness study in patients with COPD aged ≥40 years using US administrative claims data from Optum's deidentified Clinformatics® Data Mart Database. The primary and secondary endpoints were time to all-cause mortality and time to first severe cardiopulmonary event following initiation of BGF or MITT (identification period: October 1, 2020-June 30, 2023; index date: first prescription fill). Relative hazards of outcomes were assessed until a censoring event using Cox proportional hazards models, with inverse propensity treatment weighting accounting for between-group imbalances (standardized mean difference >0.1) in baseline characteristics.

RESULTS:

In the primary cohort, risk (hazard ratio [95% confidence intervals]) of all-cause mortality and a first severe cardiopulmonary event were 18% (0.82 [0.75, 0.91]) and 12% (0.88 [0.83, 0.93]) lower in patients initiating BGF versus MITT; results were consistent across censoring definitions, landmark periods, and sensitivity cohorts.

CONCLUSION:

In this real-world comparative effectiveness study of patients with COPD initiating BGF or MITT, BGF was associated with lower all-cause mortality and severe cardiopulmonary event risk versus MITT after accounting for between-group differences in baseline sociodemographic and clinical characteristics. This study supports the benefits of BGF over MITT and the need to consider proactive use of SITTs in COPD management.

105

项与布地格福相关的新闻（医药）

2025-06-19

·米内网

第十一批集采5个吸入剂备战，2个20亿大品种在列！正大天晴、普锐特、齐鲁……猛攻超200亿市场

精彩内容近日，吸入剂市场波澜再起。普锐特的瑞维那新吸入溶液、南新制药的盐酸左沙丁胺醇雾化吸入溶液报产在审，海南斯达制药的硫酸特布他林雾化吸入用溶和北京柏雅联合药物研究所的盐酸丙卡特罗吸入溶液获批上市。截至目前，吸入剂有超过40个品种报产在审，普锐特、正大天晴、齐鲁制药、长风药业等多家企业冲刺首仿。米内网数据显示，吸入剂在近年中国公立医疗机构终端销售规模均超过200亿元，2024年同比下滑1%。第十一批集采蓄势待发，5个吸入剂备战，其中2个品种销售额超过20亿元。40个吸入剂接连获批，5个产品备战第十一批集采今年以来获批上市的吸入剂来源：米内网中国申报进度（MED）数据库日前，海南斯达制药的硫酸特布他林雾化吸入用溶和北京柏雅联合药物研究所的盐酸丙卡特罗吸入溶液均以新分类报产同日获批。米内网数据显示，今年以来，吸入剂已有40个新产品获批上市。截至目前，吸入剂已有24个品种（274个品规）通过/视同通过一致性评价，吸入用乙酰半胱氨酸溶液、硫酸特布他林雾化吸入用溶液、吸入用异丙托溴铵溶液、吸入用硫酸沙丁胺醇溶液、盐酸左沙丁胺醇雾化吸入溶液过评企业均超过20家，吸入用地氟烷（恒瑞医药）、氮䓬斯汀氟替卡松鼻喷雾剂/盐酸氮䓬斯汀丙酸氟替卡松鼻喷雾剂（长风药业）、沙美特罗替卡松吸入粉雾剂（健康元药业）等8个品种为独家过评。从集团过评品种数量来看，仁合益康、倍特药业各有10个，健康元药业有9个，海南斯达制药、山东京卫制药各有6个，科伦药业、湖南华纳大药厂、苏州弘森药业、天津医药、合肥力成药业、长风药业各有5个。满足7家及以上的吸入剂产品竞争格局来源：米内网中国上市药品（MID）数据库5个吸入剂产品满足7家及以上的竞争格局，涉及康恩贝、葫芦娃药业、倍特药业、鲁南制药、长风药业等数十家企业。其中，吸入用七氟烷和吸入用乙酰半胱氨酸溶液在2024年中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端是20亿元级别大品种，分别是吸入剂TOP2、TOP3产品。TOP20洗牌！60亿大品种“腰斩”后回升，6个品牌大涨近年中国公立医疗机构终端吸入剂（化+生+中）保持200亿元以上销售规模，2024年同比略有下滑。从TOP20集团来看，阿斯利康、葛兰素史克、恒瑞医药、正大制药、健康元药业位居前五，济南景笙科技增速翻倍，倍特药业、长风药业、仁合益康等增速均超过10%。2024年中国公立医疗机构终端吸入剂产品TOP20来源：米内网中国公立医疗机构药品终端竞争格局注：标红为增速超10%产品TOP20中，吸入用布地奈德混悬液、吸入用七氟烷、吸入用乙酰半胱氨酸溶液位居前三，富马酸福莫特罗吸入溶液凭借超过300%的强劲增速上榜，也是TOP20增速最快的产品。2024年中国公立医疗机构终端吸入剂品牌TOP20来源：米内网中国公立医疗机构药品终端竞争格局注：标红为增速超10%品牌TOP20中，阿斯利康的布地奈德福莫特罗吸入粉雾剂(Ⅱ)以超20亿元销售规模领跑，上海恒瑞医药的吸入用七氟烷、阿斯利康的吸入用布地奈德混悬液和布地格福吸入气雾剂、葛兰素史克的沙美特罗替卡松吸入粉雾剂、正大天晴药业集团的吸入用布地奈德混悬液均超过10亿元。从企业品牌数量来看，阿斯利康（布地奈德福莫特罗吸入粉雾剂(Ⅱ)、吸入用布地奈德混悬液、布地格福吸入气雾剂）和葛兰素史克（沙美特罗替卡松吸入粉雾剂、氟替美维吸入粉雾剂、丙酸氟替卡松雾化吸入用混悬液）各有3个上榜，健康元（吸入用布地奈德混悬液、盐酸左沙丁胺醇雾化吸入溶液）和正大天晴药业集团（吸入用布地奈德混悬液、噻托溴铵粉雾剂）各有2个上榜。6个品牌销售额有双位数增速，阿斯利康的布地格福吸入气雾剂和葛兰素史克的氟替美维吸入粉雾剂均大涨超过30%。6个集采品种近年中国公立医院终端市场份额变化来源：米内网中国公立医疗机构药品终端竞争格局目前，吸入剂已有6个产品被纳入集采，除了吸入用复方异丙托溴铵溶液外，其余5个均在吸入剂产品TOP20之列。其中，吸入用布地奈德混悬液在中国公立医疗机构终端吸入剂产品中连续多年稳居“销冠”宝座，2021年销售规模超过60亿元，2022年受集采影响下跌超过50%，2023年-2024年止跌回升，分别同比增长22.61%、6.34%。在品牌TOP20中，吸入用布地奈德混悬液占据5个席位，4个国产品牌均为正增长，四川普锐特药业大涨27.08%、长风药业大涨26.86%、正大天晴药业集团大涨16.84%。首仿、1类新药蜂拥而至，正大天晴、普锐特、齐鲁……猛攻超200亿市场6月19日，CDE官网显示，四川普锐特药业的瑞维那新吸入溶液以仿制4类报产在审，该产品用于慢性阻塞性肺病（COPD）的维持治疗。在此之前，广州南新制药的盐酸左沙丁胺醇雾化吸入溶液以仿制3类报产在审。截至目前，吸入剂有超过40个品种（超过150个受理号）报产在审，4个产品火热，吸入用乙酰半胱氨酸溶液、富马酸福莫特罗吸入溶液、盐酸丙卡特罗吸入溶液、盐酸左沙丁胺醇雾化吸入溶液均超过10家企业报产。瑞维那新吸入溶液、乌美溴铵维兰特罗吸入粉雾剂、布地奈德福莫特罗吸入粉雾剂(Ⅱ)、沙美特罗替卡松吸入气雾剂、糠酸氟替卡松鼻用喷雾剂、酒石酸阿福特罗雾化吸入溶液等多个品种暂无仿制药获批，四川普锐特药业、正大天晴药业集团、上海新黄河制药、齐鲁制药、长风药业等多家企业冲刺首仿。今年以来获批临床的吸入剂1类新药来源：米内网中国申报进度（MED）数据库今年以来，吸入剂1类新药已有6个产品获批临床，包括四川普锐特药业的PRT-064040鼻喷雾剂、北京泰德制药的CPD704吸入混悬液、西藏海思科制药的HSK39004吸入粉雾剂等。目前，吸入剂1类新药已有29个获批临床，其中25个是呼吸系统用药。资料来源：米内网数据库、公司公告等注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

一致性评价上市批准医药出海带量采购

2025-06-10

·摩熵医药

5月141款新药获批临床！65款纳入特殊审评，涉及阿斯利康，正大天晴…

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。5月全球在研新药月报内容亮点5月国内新药获批临床情况2025年5月共有141款新药获批临床，较上个月减少了25款；5月获批临床受理号数量最多的新药为抗肿瘤药和免疫机能调节药物，有92个；5月获批剂型主要为注射剂与片剂，分别有94个，81个。全球获孤儿药/突破性/快速通道资格认定品种盘点5月共有65款药物获孤儿药/突破性/快速通道资格认定品种。全球在研创新药积极/失败临床结果最新动态速递阿斯利康开发的 Breztri Aerosphere 达到两项3期临床试验主要终点；阿斯利康与第一三共开发的 Enhertu 在 DESTINY-Breast11 临床3期试验中取得积极结果；正大天晴1类新药盐酸安罗替尼胶囊组合疗法3期临床试验数据公布，疾病进展风险降低48%；默沙东公布 zilovertamab vedotin 联合疗法2/3期临床试验积极结果。每月相关创新药最新政策速递、国内新药注册申报、全球获孤儿药/突破性/快速通道资格认定品种盘点、全球在研创新药积极/失败临床结果TOP20、全球创新药研发进展TOP20等，摩熵咨询团队基于真实可溯源的全球医药数据，将每月推出「全球在研新药月报」，以期帮助业内人士通盘把握每月全球范围内的新药开发情况，全面而深入的了解全球新药开发动态。015月国内新药获批临床/上市情况根据摩熵医药数据库统计，2025年5月共有141款新药获批临床（共计221个受理号），较上个月减少了25款，其中包括65款化药，72款生物制品，4款中药。截图来源：摩熵咨询月报5月获批临床受理号数量最多的新药为抗肿瘤药和免疫机能调节药物，有92个，占比为42%，消化系统与代谢药物获批数量也比较多，有35个。获批剂型主要为注射剂与片剂，分别有94个，81个。截图来源：摩熵咨询月报在5月份，国内医药市场迎来了10款创新药物的获批上市，涉及辽宁海思科制药有限公司的HSK-21542注射液，用于治疗成人维持性血液透析患者的慢性肾脏疾病相关的中度至重度瘙痒；恒瑞医药申报的1类创新药瑞格列汀二甲双胍片（I）/（II），该药配合饮食控制和运动，适用于适合接受磷酸瑞格列汀和盐酸二甲双胍治疗的2型糖尿病成人患者改善血糖控制；此外还有深圳信立泰药业的沙库巴曲阿利沙坦钙片，用于治疗原发性高血压。截图来源：摩熵咨询月报02全球获孤儿药/突破性/快速通道资格认定品种盘点5月共有65款药物获孤儿药/突破性/快速通道资格认定。其中值得注意的是：5月16日，据CDE官网显示，默克与四川科伦药业股份有限公司共同研发的sacituzumab tirumotecan（注射用芦康沙妥珠单抗）拟纳入优先审评，用于成人既往接受过内分泌治疗，且在晚期或转移性阶段接受过其他系统治疗的不可切除局部晚期或转移性激素受体阳性（HR+）、人表皮生长因子受体2阴性（HER2-）乳腺癌的治疗。5月本月全球孤儿药/突破性/快速通道资格认定品种（部分）一览表备注：完整数据识别文末二维码下载查看03全球在研创新药积极/失败临床结果TOP20在5月全球创新药研发动态中，5月8日，阿斯利康（AstraZeneca）与第一三共（Daiichi Sankyo）宣布，双方联合开发的重磅抗体偶联药物 Enhertu（trastuzumab deruxtecan）在DESTINY-Breast11临床3期试验当中取得积极结果。分析显示，在高风险、局部晚期HER2阳性早期乳腺癌患者中，于术前新辅助治疗阶段使用 Enhertu 联合紫杉醇、曲妥珠单抗和帕妥珠单抗（THP），在病理完全缓解（pCR）方面相较于标准治疗方案（剂量密集的阿霉素和环磷酰胺，后使用THP，即ddAC-THP）实现了具有统计学显著性和临床意义的提升。病理完全缓解被定义为治疗后在切除的乳腺组织和淋巴结中未发现浸润性癌细胞。根据新闻稿，这是首个3期临床试验证实Enhertu在早期乳腺癌中具有治疗益处。Enhertu 是阿斯利康和第一三共联合开发的ADC疗法。它采用第一三共专有的DXd ADC技术平台设计，由靶向HER2的人源化单克隆抗体通过四肽可裂解连接子，与拓扑异构酶1抑制剂有效载荷连接组成。截图来源：摩熵医药全球药物研发数据库此外，5月31日，默沙东（MSD）公布了2/3期waveLINE-003研究的积极结果，该研究评估其在研抗体偶联药物（ADC）zilovertamab vedotin 联合标准治疗利妥昔单抗和吉西他滨-奥沙利铂（R-GemOx）治疗复发或难治性弥漫性大B细胞淋巴瘤（DLBCL）的效果。在预设分析中，1.75 mg/kg剂量的 zilovertamab vedotin 联合 R-GemOx 在复发或难治性DLBCL患者（n=16）中实现了56.3%的客观缓解率（ORR），包括8例完全缓解（CR）和1例部分缓解（PR）。Zilovertamab vedotin 是一种靶向受体酪氨酸激酶样孤儿受体1（ROR1）的潜在“first-in-class”抗体偶联药物。ROR1是一种在多种血液系统恶性肿瘤中过度表达的跨膜蛋白。该疗法目前正在3期waveLINE-010研究和2期waveLINE-007研究中评估用于初治DLBCL患者。此外，2期waveLINE-011研究也在近期启动，旨在评估该疗法联合利妥昔单抗和环磷酰胺、多柔比星及泼尼松（R-CHP）对比获批ADC疗法polatuzumab vedotin联合R-CHP治疗DLBCL患者的效果。全球在研创新药积极/失败临床结果TOP20备注：完整数据识别文末二维码下载查看04全球创新药研发进展TOP20在5月全球创新药研发进展TOP20榜单中，亮点纷呈。5月6日，中国国家药监局药品审评中心（CDE）官网公示，百济神州申报的1类新药 BGB-45035片就新适应症获得临床试验默示许可，拟开发治疗结节性痒疹。BGB-45035片是一款靶向IRAK4的蛋白降解剂（IRAK4 CDAC），该产品此前于2024年8月首次在中国获批IND，用于治疗中重度特应性皮炎。IRAK4是一种支架激酶，处于先天性免疫反应与适应性免疫反应的交汇点，通过其激酶活性和支架功能执行多重作用。有研究表明，IRAK4是Toll样受体（TLRs）和IL-1受体介导的炎症发生中的关键性蛋白。据百济神州公开资料介绍，BGB-45035 具有多个优势，有希望开发成为“best-in-class”药物：IRAK4降解更快更深层次，对细胞因子抑制更强，在多种细胞类型中实现了更完全的IRAK4降解；在疾病模型中药效更好；无心血管风险。截图来源：摩熵医药全球药物研发数据库5月29日，中国国家药监局（NMPA）官网公示，复星医药1类新药芦沃美替尼（曾用名：复迈替尼）上市申请已获得批准，该药适用于朗格汉斯细胞组织细胞增生症（LCH）和组织细胞肿瘤成人患者；2岁及2岁以上伴有症状、无法手术的丛状神经纤维瘤（PN）的I型神经纤维瘤病（NF1）儿童及青少年患者。芦沃美替尼（FCN-159）是复星医药自主研发的新型小分子化学药物，为一款MEK1/2选择性抑制剂，可以抑制RAS通路异常引起的肿瘤增殖，拟主要用于晚期实体瘤、I型神经纤维瘤、树突状细胞和组织细胞肿瘤、低级别脑胶质瘤等的治疗。截图来源：摩熵医药全球药物研发数据库2025年5月全球在研新药月报完整报告识别下方二维码获取完整《2025年5月全球在研新药月报》PDF版本报告在每月初定期发布，敬请期待END本文为原创文章，转载请留言获取授权近期热门资源获取数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-2025042023H2-2024H1中国药品分析报告-2025042024年中国1类新药靶点白皮书-202503中国AI医疗健康企业创新发展百强榜单-202502解码护肤抗衰：消费偏好洞察与市场格局分析-2025022024年FDA批准上市的新药分析报告-2025012024年NMPA批准上市的新药分析报告-2025012024年医保谈判及市场分析报告-2025.012024年中国医疗健康投融资全景洞察报告-202501小分子化药白皮书（上）-2025012024医美注射材料市场发展分析报告-202412中国放射性药物产业白皮书-202410近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

2025-05-13

·Pharmaceutical Technology

MHRA approves AstraZeneca’s Trixeo Aerosphere inhaler for COPD

AstraZeneca plans to transition its pMDI portfolio to the near-zero GWP propellant by 2030. Credit: Elzbieta Krzysztof / Shutterstock. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved AstraZeneca’s Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF) inhaler for use with a propellant with near-zero Global Warming Potential (GWP), to treat adults with chronic obstructive pulmonary disease (COPD). This step marks the first time a medicine delivered by a pressurised metered-dose inhaler (pMDI) utilises a propellant with a 99.9% lower GWP compared to currently used propellants. The approval was based on the propellant clinical development programme outcomes, which confirmed bioequivalence between Trixeo with the new propellant, HFO-1234ze(E), and the existing propellant, HFA-134a. Trixeo’s tolerability and safety profile were found to be consistent with its known characteristics. Trixeo, known as Breztri Aerosphere in the US, China, and Japan, is a fixed-dose triple-combination therapy for COPD. The therapy combines a long-acting β2 agonist (LABA), a long-acting muscarinic antagonist (LAMA), and an inhaled corticosteroid (ICS), delivered through the Aerosphere pMDI. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence AstraZeneca plans to transition its pMDI portfolio to the near-zero GWP propellant by 2030, aligning with its Ambition Zero Carbon strategy. The transition of Trixeo Aerosphere in the UK is set to begin in the coming months. Regulatory applications for Trixeo/Breztri Aerosphere with the next-generation propellant are also under review in China, Europe, and other nations. AstraZeneca biopharmaceuticals business unit executive vice-president Ruud Dobber said: “The UK approval of Trixeo Aerosphere with the next-generation propellant is an industry first and a major milestone in AstraZeneca’s commitment to transition our pMDI portfolio to the propellant with near-zero GWP. “Starting with Trixeo, we are addressing the needs of both patients and the environment in devastating diseases like COPD, which affects hundreds of millions of people and is a leading cause of death globally.” Honeywell-developed medical-grade HFO-1234ze(E) is pivotal for decreasing the climate impact of pMDI medicines. In 2022, AstraZeneca announced a partnership with Honeywell to develop respiratory inhaled medicines with the new propellant. As part of its Ambition Zero Carbon strategy, AstraZeneca is progressing towards net zero emissions, targeting a 98% reduction in greenhouse gas emissions from its operations by 2026, from a 2015 baseline.

上市批准

100 项与布地格福相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	R03AL11	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
慢性支气管炎	日本	AstraZeneca KK	2019-06-18
慢性阻塞性肺疾病	日本	AstraZeneca KK	2019-06-18
肺气肿	日本	AstraZeneca KK	2019-06-18

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
中度慢性阻塞性肺疾病	临床3期	美国	阿斯利康投资（中国）有限公司	2015-08-20
中度慢性阻塞性肺疾病	临床3期	美国	AstraZeneca Dunkerque Production SCS	2015-08-20
中度慢性阻塞性肺疾病	临床3期	美国	Pearl Therapeutics, Inc.	2015-08-20
中度慢性阻塞性肺疾病	临床3期	日本	阿斯利康投资（中国）有限公司	2015-08-20
中度慢性阻塞性肺疾病	临床3期	日本	Pearl Therapeutics, Inc.	2015-08-20
中度慢性阻塞性肺疾病	临床3期	日本	AstraZeneca Dunkerque Production SCS	2015-08-20
中度慢性阻塞性肺疾病	临床3期	加拿大	阿斯利康投资（中国）有限公司	2015-08-20
中度慢性阻塞性肺疾病	临床3期	加拿大	AstraZeneca Dunkerque Production SCS	2015-08-20
中度慢性阻塞性肺疾病	临床3期	加拿大	Pearl Therapeutics, Inc.	2015-08-20
严重慢性阻塞性肺疾病	临床3期	美国	阿斯利康投资（中国）有限公司	2015-08-20

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临床结果

适应症

分期

评价

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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


NCT05477108 (CTgov)	临床1期	慢性阻塞性肺疾病	108	BGF (Treatment A)	蓋膚艱夢簾構簾構築繭(獵遞選鏇簾艱積願選淵) = 襯積積壓鏇餘鬱襯顧艱選夢壓繭顧鬱襯廠鏇醖 (遞觸簾獵鹹範鑰願觸網, 61.09) 更多	-	2025-05-28
				BGF (Treatment B (Replicate 1))	蓋膚艱夢簾構簾構築繭(獵遞選鏇簾艱積願選淵) = 鏇願築鏇築壓蓋觸構膚選夢壓繭顧鬱襯廠鏇醖 (遞觸簾獵鹹範鑰願觸網, 63.42) 更多
Arctos Study (ATS2025)	N/A	慢性阻塞性肺疾病维持	461	Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	艱鬱鹹憲鹹醖齋願廠鏇(遞網築製襯壓醖鑰範鬱) = 衊選齋鑰簾艱齋膚糧壓蓋夢鏇遞醖鏇襯餘襯夢 (淵鹽築醖鑰願衊壓選憲, 3284) 更多	积极	2025-05-16
MITOS EROS+CP (US) Study (ATS2025)	N/A	哮喘-慢性阻塞性肺疾病重叠综合征	8,837	Prompt initiation of Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	選鑰願糧艱壓網蓋觸網(願壓積憲窪憲觸鏇艱蓋) = 築範獵膚鏇製淵襯顧衊襯糧築齋餘鹽艱願鹹範 (淵衊鬱廠顧醖衊顧觸鹹, 1.30 ~ 1.45)	积极	2025-05-16
				Delayed initiation of Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	選鑰願糧艱壓網蓋觸網(願壓積憲窪憲觸鏇艱蓋) = 窪廠淵顧積顧鬱齋願鹽襯糧築齋餘鹽艱願鹹範 (淵衊鬱廠顧醖衊顧觸鹹, 1.85 ~ 1.94)
NCT04609878 (KALOS, Company_Website) 人工标引	临床3期	哮喘	-	Breztri Aerosphere	壓鑰簾醖糧衊範鏇觸遞(願鹽構構醖夢糧構鬱築) = met all primary endpoints 觸糧襯簾鏇醖淵構獵淵 (蓋艱範壓觸襯襯觸齋鏇 ) 达到	积极	2025-05-02
				Budesonide and formoterol fumarate
NCT04609904 (LOGOS, Company_Website) 人工标引	临床3期	哮喘	-	Breztri Aerosphere	製鏇艱衊醖鑰夢願獵獵(蓋鏇糧築餘築憲醖壓鑰) = met all primary endpoints 築願餘餘艱蓋鑰襯鑰構 (網夢齋顧壓艱遞遞淵製 ) 达到	积极	2025-05-02
				Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg
NCT05569421 (CTgov)	临床1期	慢性阻塞性肺疾病	108	BAB+BGF (Treatment A)	齋選醖衊淵餘獵窪齋鏇(觸顧夢網鬱衊網構觸範) = 餘積鏇蓋鏇構構願醖醖醖醖餘艱窪繭艱齋獵顧 (鹽鬱鏇獵鏇構積夢鏇窪, 46.71) 更多	-	2025-04-29
				BAB+BGF (Treatment B (Replicate 1))	齋選醖衊淵餘獵窪齋鏇(觸顧夢網鬱衊網構觸範) = 鹽網蓋夢鹹蓋鬱選淵醖醖醖餘艱窪繭艱齋獵顧 (鹽鬱鏇獵鏇構積夢鏇窪, 40.78) 更多
ATS2024	N/A	慢性阻塞性肺疾病	-	Budesonide/Glycopyrrolate/Formoterol (BGF)	憲蓋淵獵膚鹽鹽蓋簾網(獵艱製鏇積膚壓糧淵鏇) = 夢衊選廠遞糧蓋窪淵蓋繭顧糧範願糧壓窪顧齋 (願餘憲餘選淵鹽選願壓 )	-	2024-05-19
				Multiple Inhaler Triple Therapy (MITT)	憲蓋淵獵膚鹽鹽蓋簾網(獵艱製鏇積膚壓糧淵鏇) = 襯蓋遞顧艱願繭繭鏇夢繭顧糧範願糧壓窪顧齋 (願餘憲餘選淵鹽選願壓 )
ATS2023	N/A	慢性阻塞性肺疾病	-	Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	膚憲築簾繭願窪構鹹蓋(餘獵網糧壓鹹餘範範廠): HR = 0.61 (95% CI, 0.38 ~ 0.95), P-Value = 0.030	-	2023-05-21
				Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)
ATS2023	N/A	慢性阻塞性肺疾病	-	Prompt BGF initiation (≤30 days)	襯餘鹹構艱壓鬱築襯憲(繭網鑰襯網鹽遞簾鬱醖) = 選製顧獵繭製鏇鹽願糧醖鹹築淵窪醖膚鹹壓淵 (鏇憲衊艱獵憲膚壓遞積, 0.04 ~ 0.09) 更多	-	2023-05-21
				Delayed BGF initiation (31-180 days)	襯餘鹹構艱壓鬱築襯憲(繭網鑰襯網鹽遞簾鬱醖) = 壓襯齋鑰繭範蓋醖襯窪醖鹹築淵窪醖膚鹹壓淵 (鏇憲衊艱獵憲膚壓遞積, 0.06 ~ 0.10) 更多
NCT02497001 (Pubmed \| Appl Health Econ Health Policy)	临床3期	严重慢性阻塞性肺疾病	1,902	Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	艱襯網選淵憲夢觸築觸(積糧鑰廠窪衊襯範艱製) = 廠廠鬱襯顧艱襯選憲網壓鹹簾壓網鹹夢製衊築 (餘餘廠膚願夢齋積憲觸 ) 更多	-	2022-09-01
				Long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA)	艱襯網選淵憲夢觸築觸(積糧鑰廠窪衊襯範艱製) = 積膚鹽夢蓋衊衊艱衊網壓鹹簾壓網鹹夢製衊築 (餘餘廠膚願夢齋積憲觸 ) 更多