预约演示

更新于：2026-05-19

Beclometasone Dipropionate/Formoterol fumarate Dihydrate/Glycopyrronium Bromide

二丙酸倍氯米松/富马酸福莫特罗二水合物/格隆溴铵

更新于：2026-05-19

概要

基本信息

药物类型

小分子化药

别名

Beclometasone Dipropionate Anhydrous/Formoterol Fumarate Dihydrate/Glycopyrronium、Beclometasone dipropionate anhydrous/formoterol fumarate dihydrate/glycopyrronium bromide、Beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium

+ [10]

靶点

GR x mAChRs x β2-adrenergic receptor

作用方式

激动剂、拮抗剂

作用机制

GR激动剂(糖皮质激素受体激动剂)、mAChRs拮抗剂(毒蕈碱型乙酰胆碱受体家族拮抗剂)、β2-adrenergic receptor激动剂(β2-肾上腺素能受体激动剂)

治疗领域

免疫系统疾病呼吸系统疾病

在研适应症

哮喘慢性阻塞性肺疾病

非在研适应症

新型冠状病毒感染肺气肿

原研机构

CHIESI Farmaceutici SpA

在研机构

CHIESI Farmaceutici SpA

凯西医药咨询（上海）有限公司

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

欧盟 (2017-07-17),

哮喘慢性阻塞性肺疾病

最高研发阶段(中国)批准上市

特殊审评-

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结构/序列

分子式C28H37ClO7

InChIKeyKUVIULQEHSCUHY-XYWKZLDCSA-N

CAS号5534-09-8

查看全部结构式(3)

关联

项与二丙酸倍氯米松/富马酸福莫特罗二水合物/格隆溴铵相关的临床试验

NCT07406048

/ RecruitingN/A

A Real-World Study Evaluates the Clinical Characteristics and Effectiveness of COPD Patients Treated With the Triple Combination Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (BDP/FF/GB) in a Single Pressurised Metered Dose Inhaler (Trimbow® pMDI) in Brazil

This multicenter, retrospective-prospective, cohort study aims to evaluate the effectiveness and safety of Extra-fine Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (EF-BDP/FF/GB) therapy in adults with severe or very severe COPD in Brazil. Around 400 patients will be enrolled across approximately 15 sites. Eligible patients must have started treatment on the day of enrollment or up to three months before enrollment. Data will be collected both retrospectively and prospectively, with baseline information covering up to 12 months before treatment initiation. All assessments will occur during routine medical visits, with follow-up expected at approximately 3 ± 1 month and 6 months ± 2 months. The medication Trimbow® will not be provided as part of the study and must be prescribed and used according to the institution's standard clinical practice, regardless of participation in the study.

开始日期2026-04-01

申办/合作机构

Chiesi Farmacêutica Ltda.

NCT07282886

/ Recruiting临床2期IIT

Open-label, Prospective, Crossover, Proof-of-concept Study to Evaluate the Effect of Triple Therapy With Extrafine Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrrolate (BDP/FF/G) Via pMDI Compared With Non-extrafine Fluticasone Furoate/Umeclidinium/Vilanterol (FluF/UMEC/VI) Via DPI on Lung Ventilation and Clinical Outcomes in Subjects With Moderate to Severe Asthma

The purpose of the study is to enroll participants with uncontrolled asthma to evaluate the large and small airways and drug delivery utilizing two study drugs:
* Beclometasone dipropionate/Formoterol fumarate dihydrate/Glycopyrronium bromide (BDP/FF/G) or Trimbow
* Fluticasone furoate/Umeclidinium/Vilanterol (FluF/UMEC/VI ) or Trelegy Ellipta

开始日期2026-03-15

申办/合作机构

The University of Alabama at Birmingham

NCT07301736

/ Recruiting临床2期

A Phase II Multinational, Multicentre, Double-blind, Randomised, Active-controlled, 3-way Cross-over Study to Evaluate the Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a Versus CHF5993 pMDI 100/6/12.5 µg HFA-134a in Subjects With Mild to Moderate Asthma

This study will compare an asthma inhaler that uses a new climate friendly alternative propellant to an asthma inhaler with an existing propellant. We want to make sure both versions of the inhaler work the same way for people with mild to moderate asthma.

开始日期2025-12-17

申办/合作机构

CHIESI Farmaceutici SpA

100 项与二丙酸倍氯米松/富马酸福莫特罗二水合物/格隆溴铵相关的临床结果

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100 项与二丙酸倍氯米松/富马酸福莫特罗二水合物/格隆溴铵相关的转化医学

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100 项与二丙酸倍氯米松/富马酸福莫特罗二水合物/格隆溴铵相关的专利（医药）

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项与二丙酸倍氯米松/富马酸福莫特罗二水合物/格隆溴铵相关的文献（医药）

2026-04-01·Lancet Respiratory Medicine

Budesonide–glycopyrronium–formoterol fumarate dihydrate in uncontrolled asthma (KALOS and LOGOS): twin multicentre, double-blind, double-dummy, parallel-group, randomised, phase 3 trials

Article

作者: Bondoc, Marco ; Springer, Katarzyna ; Shah, Mihir ; Jackson, David J ; Papi, Alberto ; Obasi, Chidi ; Helman, Jesse ; Wise, Robert A ; Bowen, Karin ; Patel, Mehul ; Salter, Patricia ; Movitz, Charlotta ; Chen, Ruchong ; Lugogo, Njira ; Pandya, Hitesh ; Megally, Ayman ; Trasieva, Teodora ; Knappenberger, Katharine

BACKGROUND:

Long-acting muscarinic antagonists (LAMA) can be added to inhaled corticosteroid- (ICS)-long-acting β₂-agonist (LABA) therapy for inadequately controlled asthma. We aimed to evaluate the efficacy and safety of budesonide-glycopyrronium-formoterol fumarate dihydrate (BGF) versus budesonide-formoterol fumarate dihydrate using Aerosphere co-suspension delivery technology (BFF_A) and the current suspension formulation (Symbicort, BFF_S).

METHODS:

Two multicentre, randomised, double-blind, double-dummy, phase 3 studies (KALOS and LOGOS) recruited participants aged 12-80 years with inadequately-controlled asthma despite daily medium-dose or high-dose ICS-LABA use from across 378 sites in 20 countries (KALOS), and 324 sites in 15 countries (LOGOS). Participants were randomly assigned (1:1:1:1) to BGF 320 μg, 28·8 μg, 10 μg (BGF 28·8); BGF 320 μg, 14·4 μg, 10 μg (BGF 14·4); BFF_A 320 μg, 10 μg; or BFF_S 320 μg, 9 μg, twice a day via pressurised metered-dose inhaler for 24-52 weeks. Primary lung function endpoints were change from baseline in FEV₁ area under the curve from 0 h to 3 h (AUC_0-3) and in morning pre-dose trough FEV₁ from day 1 to week 24 (over 24 weeks; depending on regional health authority guidance). The primary pooled analysis across both studies was annualised severe exacerbations. The efficacy analysis set and safety set included all randomly assigned participants receiving any amount of study treatment but were analysed according to randomly assigned treatment and received treatment, respectively. The KALOS and LOGOS studies are registered with ClinicalTrials.gov (NCT04609878 and NCT04609904, respectively) and are complete.

FINDINGS:

Between Dec 15, 2020, and March 21, 2025 (KALOS), and between March 1, 2021, and March 20, 2025 (LOGOS), 8820 participants were recruited and 4311 received treatment (1179 received BGF 28·8, 726 received BGF 14·4, 1210 received BFF_A, and 1196 received BFF_S). In each study, the pre-specified multiplicity-adjusted primary endpoints for all regulatory comparisons were met. Least squares mean differences favoured BGF 28·8 for change from baseline in trough FEV₁ and FEV₁ AUC_0-3 across all comparisons (all p<0·05). Least squares mean differences in change from baseline in morning pre-dose trough FEV₁ and in FEV₁ AUC_0-3 over 24 weeks for BGF 28·8 versus BFF_combined were 76 mL (95% CI 57-94; p<0·0001) and 90 mL (72-108; p<0·0001), respectively. BGF 28·8 reduced severe exacerbation rates versus BFF_combined (incidence rate ratio 0·86, 95% CI 0·76-0·97; p=0·012) and versus BFF_S (0·82, 0·71-0·94; p=0·0043). Exacerbation rate ratio for BGF 28·8 versus BFF_A was 0·90 (95% CI 0·78-1·03; p=0·12). 627 (53·2%) adverse events were observed with BGF 28·8, 436 (60·0%) with BGF 14·4, 666 (55·2%) with BFF_A, and 698 (58·4%) with BFF_S. No deaths were treatment related.

INTERPRETATION:

These findings show that BGF improves lung function and reduces severe exacerbation rates in a broad population with asthma inadequately controlled despite medium-dose or high-dose ICS-LABA use. Given that these findings were observed regardless of recent exacerbation history, BGF could benefit individuals with inadequately controlled asthma without requiring a recent episode of acute deterioration on ICS-LABA before escalation.

FUNDING:

AstraZeneca.

2026-03-01·Pulmonary Therapy

Real-World Outcomes in Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate After Dual and Triple Therapy in Spain: A Sub-Study of the ORESTES Study

Article

作者: Fitas, Eunice ; Sánchez-Covisa, Joaquín ; Pallarés-Sanmartín, Abel ; Alcázar-Navarrete, Bernardino ; Pascual-Guardia, Sergi ; Gotera-Rivera, Carolina María ; González, Jessica ; Margallo-Iribarnegaray, Juan ; Corregidor-García, Carmen ; Casitas-Mateo, Raquel ; Martín-Lana, Marta ; Saura-Vinuesa, Alberto ; Herrejón-Silvestre, Alberto ; Figueira-Gonçalves, Juan Marco

INTRODUCTION:

Chronic obstructive pulmonary disease (COPD) is a progressive lung condition associated with high morbidity and mortality. Single-inhaler triple therapy (SITT), such as budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF), is recommended for patients with COPD who are not adequately controlled by dual therapy (DT). Escalation from DT or switching from triple therapy (TT)-SITT or multiple-inhaler TT (MITT)-are key real-world treatment pathways.

METHODS:

The observational, retrospective, multicenter ORESTES study included adults (≥ 40 years) with COPD initiating BGF in routine clinical practice. This secondary analysis focuses on the following treatment pathways: escalation from DT and switch from TT. Patients' characteristics, exacerbations, additional COPD treatments, and healthcare resource utilization (HCRU) were assessed.

RESULTS:

A total of 295 patients escalated from DT and 356 switched from TT (SITT: 147; MITT: 209) to BGF. 66.8% of patients escalating from DT and 78.5% switching from TT showed a high-risk GesEPOC phenotype; 77.9% and 80.0% had mMRC grade ≥ 2, and 91.2% and 96.1% had ≥ 3 comorbidities. Following BGF initiation, the annualized exacerbation rate decreased by 11.6% (from 1.06 to 0.94) in patients escalating from DT and by 15.5% (from 1.60 to 1.35) in patients switching from TT (after SITT: 17.8% reduction; after MITT: 14.1%). Rescue medication use declined overall, and specifically short-acting beta-2 agonists (SABA) use declined by 23.2% and 19.4% (SITT: 21.9%; MITT: 18.4%). Emergency room visits and hospitalizations decreased by 19.7% and 19.0% in patients escalating from DT, and by 29.4% and 25.5% among those switching from TT (SITT: 25.0%/18.3%; MITT: 32.4%/29.9%).

CONCLUSIONS:

In this real-world Spanish cohort of patients with COPD not adequately controlled with DT or TT, reductions in exacerbations, rescue medication use, and HCRU were observed after BGF initiation, supporting the potential value of earlier introduction of BGF in patients with persistent symptoms and/or frequent exacerbations despite high-intensity therapy.

CLINICAL TRIAL REGISTRATION:

NCT06321731.

2026-03-01·CLINICAL THERAPEUTICS

Safety Assessment of Budesonide/Formoterol: Real-World Pharmacovigilance Analysis Using the FAERS, JADER, and CVAR Databases

Article

作者: Zou, Fan ; Chen, Zhenyong ; Zhu, Chengyu ; Lan, Yuanbo ; Cui, Zhiwei

BACKGROUND:

Asthma and chronic obstructive pulmonary disease are common respiratory disorders with significant global health implications. Budesonide/formoterol (Symbicort) is a fixed-dose inhaler combining budesonide and formoterol fumarate dihydrate, widely used for disease management. While its clinical efficacy is well established, there is an increasing number of adverse drug event (ADE) reports, highlighting the need for thorough real-world safety evaluations.

METHODS:

We performed a retrospective pharmacovigilance study using three major spontaneous reporting systems: the US Food and Drug Administration Adverse Event Reporting System (FAERS), the Japanese Adverse Drug Event Report (JADER), and the Canada Vigilance Adverse Reaction Database (CVARD). We used multiple disproportionality algorithms, including reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker for signal detection. Additionally, subgroup and sensitivity, along with logistic regression, were performed. Weibull distribution and log-rank testing were used to assess event timing.

RESULTS:

A total of 30,689 ADEs were identified in FAERS, spanning 27 system organ classes. Expected signals such as cough, dysphonia, and bronchitis were confirmed. Unexpected events included dyspnea, visual and memory impairment, coronary artery embolism, and asthmatic crisis. Sex-stratified analysis revealed female-specific risks (eg, malaise, bronchitis, alopecia, weight gain) and male-specific risks (eg, dysuria, myocardial infarction). Younger patients (<18 years) were at higher risk for asthmatic crisis, whereas older patients (>65 years) showed a protective effect. The median onset of ADEs was 55 days. Distinctive signals emerged from JADER (eg, pneumonia, liver injury) and CVARD (eg, hemoptysis, hypothyroidism).

CONCLUSIONS:

This multi-database analysis highlights the need for continuous pharmacovigilance for budesonide/formoterol. The identification of novel ADE signals emphasizes the importance of vigilant monitoring, especially during early treatment, to enhance safety and therapeutic outcomes.

项与二丙酸倍氯米松/富马酸福莫特罗二水合物/格隆溴铵相关的新闻（医药）

2026-05-08

·米内网

【市场】21个新药进院可期，独家品种成爆款

精彩内容日前，什邡市中医医院公告称，将引进21个新药以满足临床用药需求，“中化生”领域皆有涉及。其中，独家品种（含剂型独家，下同）占比超40%，不乏异甘草酸镁注射液等2025年在中国公立医疗机构终端销售额超20亿元的畅销药，以及注射用重组人TNK组织型纤溶酶原激活剂等销售额增速达三位数的潜力品种。 21个进院的新药包含14个化药、6个中成药和1个生物药；从剂型上看，片剂和注射剂为主力军，分别占8个和5个席位；按治疗大类统计，神经系统药物、血液和造血系统药物均以3个产品在数量上领跑；医保分类方面，医保甲类药、医保乙类药和非医保药各有7个、11个和3个。进院新药名单来源：什邡市中医医院，米内网整理注：带*为独家品种异甘草酸镁注射液是正大天晴药业的独家品种，属于第四代甘草酸制剂，用于慢性病毒性肝炎以及改善肝功能异常，目前已纳入国家医保乙类药目录。在中国城市公立医院、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，该药2022-2025年销售规模均在24亿元以上，连续多年摘下胆、肝疾病治疗药（化+生）产品TOP1桂冠，市场份额均超14%。 2025年中国公立医疗机构终端胆、肝疾病治疗药（化+生）产品格局来源：米内网中国公立医疗机构药品终端竞争格局注射用重组人TNK组织型纤溶酶原激活剂属于第三代溶栓药，用于急性心肌梗死患者的溶栓治疗，目前国内仅石药集团拥有生产批文。米内网数据显示，自2015年首次获批上市以来，该产品在中国公立医疗机构终端销售额增速均达两位数及以上；2025年更拿下创新高的超11亿元，同比暴涨309.12%，在酶类（化+生）产品格局中攀升至第二位，产品潜力在持续释放。近年来中国公立医疗机构终端注射用重组人TNK组织型纤溶酶原激活剂销售趋势（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局此外，新增进院的药品还包括：用于腰腿疼痛的腰痹通胶囊、治疗急/慢性肝炎的肝爽颗粒、用于干眼症的维生素A棕榈酸酯眼用凝胶等独家品种，以及复方电解质醋酸钠葡萄糖注射液、尼可地尔片等2025年在中国公立医疗机构终端销售额超9亿元的畅销药，盐酸氢吗啡酮缓释片、倍氯福格吸入气雾剂等销售额增速达三位数及以上的潜力品种。资料来源：米内网数据库、什邡市中医医院注：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。数据统计截至5月8日，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

上市批准

2026-03-12

·自由鼻肺站

慢阻肺老发作？阿奇霉素抗生素或许能帮上忙，但这4类人别碰！

自由鼻肺站导读咳嗽咳痰突然加重、呼吸困难加剧，急诊、住院接踵而至——这是许多慢阻肺患者最怕的"急性加重"。当规范吸入治疗仍挡不住频繁发作时，医生可能会提出一个方案：长期小剂量服用阿奇霉素。但这绝非"没事吃两颗防感冒"的用法。用对了，急性加重可能减少30%-40%；用错了，心脏、听力都可能出问题。今天说清谁能用、怎么用、怎么避坑。谁能用？四大门槛缺一不可 1. 频繁加重是硬指标过去一年至少3次需要医疗干预的急性加重（用抗生素、激素或急诊/住院），或每年2次以上中度加重、1次需住院的重度加重。 2. 基础治疗已到位必须已规范使用长效支气管扩张剂（LABA/LAMA）和/或吸入激素，且病情仍控制不住。 3. 能配合监测需在具备心电图、听力、肝功能监测能力的医疗中心启动，并承诺定期随访。 4. 吸烟者获益有限当前仍在吸烟的患者，疗效可能大打折扣。研究数据显示，吸烟者使用20年净获益概率仅36.8%，而戒烟者可达99.9%。怎么用？剂量和疗程有讲究推荐方案： l 每日方案：250mg，每日一次，连续12个月 l 脉冲方案：500mg，每周3次，持续12个月关键提醒：这是预防维持剂量，与治疗肺炎的短期大剂量完全不同。疗程暂定为1年，满期后需由医生根据加重频率、耐受情况重新评估是否继续。目前缺乏超过1年的长期安全性数据，不建议无限期服用。这4类人千万别碰 l 对大环内酯类药物过敏者 l 已有明显QT间期延长或严重心律失常病史 l 正在合用其他显著延长QT间期的药物 l 严重肝功能不全、已有听力障碍者需格外谨慎指南怎么说？ GOLD 2024/2026报告：认可阿奇霉素在减少特定人群急性加重方面的证据（A级），但明确指出需权衡耐药、心脏及耳毒性风险，且缺乏超过1年的安全性数据。英国NICE指南：推荐阿奇霉素作为一线预防用药（250mg每周3次），但强调仅限戒烟者，且需满足频繁加重、基础治疗已优化等严格条件。西班牙GesEPOC 2025指南：对充分吸入治疗后仍≥3次加重的患者，可考虑长期大环内酯类治疗（弱推荐），强调个体化决策与严密监测。一句话总结长期小剂量阿奇霉素是慢阻肺管理中的一把双刃剑：用对人、用对法，可能显著减少急性加重；用错人、缺监测，则可能带来耐药、心脏、听力等多重风险。核心原则：严格筛选患者，采用指南推荐剂量，在专业中心启动并定期复查，满1年必须重新评估。新药分享胸闷气短咳不停？4项慢阻肺新药临床全国招募，为您呼吸带来新希望！针对过敏性鼻炎、慢性鼻窦炎、哮喘、慢阻肺等疾病，国内外仍有多种新药处于临床试验阶段。包括礼来Lebrikizumab来瑞组单抗/特泽鲁单抗同靶点/美泊利珠单抗同原理生物制剂、国外上市脱敏喷剂含片等。既往治疗效果不佳，经济困难的患者不妨多给自己一次机会。临床均在三甲医院开展，专家随访，符合条件的患者体检用药均不收费，部分项目补贴1万多。新药临床扫码报名进美泊利珠患者群参考文献： 1.Albert RK, et al. Azithromycin for prevention of exacerbations of COPD. N Engl J Med. 2011;365:689-98. 2.NICE Guideline NG115. Chronic obstructive pulmonary disease in over 16s: diagnosis and management. 2018; updated 2024. 3.Thorax. 获益-危害分析研究. 2021. 4.GOLD 2026 Report. Global Strategy for the Diagnosis, Management, and Prevention of COPD. 5.呼吸界. 防感染？当心旧病未愈又添新疾. 2025. 6.eBiotrade. 综述：通过抗菌治疗减少COPD急性加重频率. 2025. 7.ERS 2025 Guidelines for Bronchiectasis. 8.医学界呼吸频道. 阿奇霉素预防慢阻肺急性加重：剂量与疗程. 2025. 本文仅做参考，不构成对任何药物或诊疗方案的推荐、推广或宣传，也不可替代专业医疗建议。如有问题，请咨询医疗卫生专业人士。材料图片等源自网络，侵删。往期回顾美泊利珠单抗最新用法用量，这些注意事项别忽略（哮喘/慢阻肺/鼻窦炎）布地格福vs倍氯福格，慢阻肺患者怎么选？（不良反应/成分价格/使用方式）点赞分享本文，让更多患者受益~ 点分享点收藏点在看点点赞

2026-03-12

·米内网

【市场】3款国谈药拟遴选进院

精彩内容日前，四川省内江市第六人民医院发布公告，拟对5个药品进行公开院内遴选采购，报名时间截至3月13日17:30。经梳理，5个药品均为化学药，且均已纳入国家医保乙类目录，包括非奈利酮片、倍氯福格吸入气雾剂等2025年前三季度销售额增速达三位数的高增长品种。此次拟遴选进院的药品均为化学药，且均已纳入国家医保乙类目录，其中盐酸拉贝洛尔氯化钠注射液、非奈利酮片、倍氯福格吸入气雾剂均为国谈药（以2025版国家医保目录计）。 5个药品中，心脑血管系统药物有2个，呼吸系统用药、肌肉-骨骼系统、消化系统及代谢药各有1个；剂型上较为丰富，注射剂、片剂、吸入剂、口服溶液剂均有。院内遴选药品名单来源：内江市第六人民医院，米内网数据库米内网数据显示，在2025年前三季度中国城市公立医院、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，非奈利酮片、倍氯福格吸入气雾剂、氯化钾口服溶液销售额增速均达三位数。非奈利酮片是拜耳开发的一款新型非甾体选择性盐皮质激素受体(MR)拮抗剂，主要用于治疗与2型糖尿病相关的慢性肾脏疾病。该药近年来在中国公立医疗机构终端快速放量，2024年其销售额超过4亿元，同比增长约258%；2025年前三季度超过6亿元，同比增长约133%。近年来中国公立医疗机构终端非奈利酮片销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局目前国内针对非奈利酮片的仿制药开发一片火热。湖南明瑞制药的产品已于2025年11月获批上市，顺利拿下首仿；此外，上海现代制药、华北制药、甘李药业、青峰医药、石家庄四药、科伦药业等40余家企业的产品报产在审。倍氯福格吸入气雾剂是是由糖皮质激素丙酸倍氯米松、长效β2受体激动剂福莫特罗和长效毒蕈碱受体拮抗剂格隆溴铵组成的三复方吸入气雾剂，适用于慢性阻塞性肺疾病(COPD)患者的维持治疗。Chiesi的倍氯福格吸入气雾剂最早于2022年获批进入国内市场，2024年及2025年前三季度在中国公立医疗机构终端的销售额增速均达三位数。近年来中国公立医疗机构终端倍氯福格吸入气雾剂销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围：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。数据统计截至3月12日，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

100 项与二丙酸倍氯米松/富马酸福莫特罗二水合物/格隆溴铵相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	R03AL09	-

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
哮喘	欧盟	CHIESI Farmaceutici SpA	2017-07-17
哮喘	冰岛	CHIESI Farmaceutici SpA	2017-07-17
哮喘	列支敦士登	CHIESI Farmaceutici SpA	2017-07-17
哮喘	挪威	CHIESI Farmaceutici SpA	2017-07-17
慢性阻塞性肺疾病	欧盟	CHIESI Farmaceutici SpA	2017-07-17
慢性阻塞性肺疾病	冰岛	CHIESI Farmaceutici SpA	2017-07-17
慢性阻塞性肺疾病	列支敦士登	CHIESI Farmaceutici SpA	2017-07-17
慢性阻塞性肺疾病	挪威	CHIESI Farmaceutici SpA	2017-07-17

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
肺气肿	临床3期	比利时	CHIESI Farmaceutici SpA	2021-05-18
肺气肿	临床3期	匈牙利	CHIESI Farmaceutici SpA	2021-05-18
新型冠状病毒感染	临床2期	巴西	CHIESI Farmaceutici SpA	2021-06-28

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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


NCT04876677 (DARWiIN, CTgov)	临床3期	慢性阻塞性肺疾病 \| 肺气肿	25	CHF5993 (CHF5993 DPI 100/6/12.5 μg - PP Population)	膚醖蓋衊衊遞網簾淵壓(範繭壓糧遞憲鏇獵築壓) = 繭蓋網糧夢膚鹽襯憲願顧鏇齋觸鹹遞糧鹽簾襯 (繭衊選鬱製獵壓鬱獵蓋, 0.6647) 更多	-	2026-04-09
				SAF+CHF5993 DPI (CHF5993 DPI 100/6/12.5 μg - SAF Population)	艱鹹簾範觸繭願範廠製(蓋積網醖衊選簾艱蓋憲) = 餘鑰齋鑰餘廠齋網鏇窪壓憲膚夢夢積廠網選鬱 (獵夢憲獵範廠遞願憲願, 艱蓋膚簾窪願鏇齋膚繭 ~ 顧網獵鏇窪餘淵遞齋鹹) 更多
NCT04876677 (Pubmed \| Respir Res)	临床3期	慢性阻塞性肺疾病	-	Fluticasone propionate/salmeterol (FP/SLM)	鑰構醖淵齋繭繭窪網鹹(糧顧廠膚艱膚艱壓鑰鑰) = 膚製襯窪鬱蓋築鬱齋蓋夢製選淵襯壓顧鬱艱遞 (範繭觸構選蓋壓艱製廠 )	-	2023-10-06
NCT01917331 (TRILOGY, ERS2020)	临床3期	严重慢性阻塞性肺疾病维持	445	extra-fine BDP/FF/GB pMDI	觸膚窪顧醖壓廠鏇願繭(鹽製膚構襯襯築鹽襯鏇): 0.769 (95% CI, 0.632 ~ 0.936), P-Value = 0.009	积极	2020-09-07
				non-triple maintenance therapies
TRIMARAN (ERS2019)	临床3期	哮喘追加	1,155	extrafine MS beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FF/GB)	築顧顧艱繭網築遞製繭(艱鹹鑰願醖鏇艱膚鹹鏇) = 鑰廠願範鑰糧鹽膚齋窪鬱繭築鏇簾齋顧積窪遞 (夢壓顧淵鬱簾齋壓鑰廠 )	-	2019-09-28
				BDP/FF	築顧顧艱繭網築遞製繭(艱鹹鑰願醖鏇艱膚鹹鏇) = 蓋衊網鹽範淵糧積鏇廠鬱繭築鏇簾齋顧積窪遞 (夢壓顧淵鬱簾齋壓鑰廠 )
NCT01917331 (TRILOGY, Pubmed \| Lancet) 人工标引	临床3期	慢性阻塞性肺疾病	1,368	beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide	鏇鹹顧鑰艱醖艱範壓製(鏇構艱憲獵觸齋築範鹹) = 壓憲廠選夢鏇顧窪繭鹹築選壓壓顧壓壓鑰選遞 (蓋積壓齋憲鏇選獵齋壓 ) 更多	优效	2016-09-03
				beclometasone dipropionate and formoterol fumarate	鏇鹹顧鑰艱醖艱範壓製(鏇構艱憲獵觸齋築範鹹) = 鏇鑰遞遞夢糧襯糧衊淵築選壓壓顧壓壓鑰選遞 (蓋積壓齋憲鏇選獵齋壓 ) 更多