预约演示
更新于：2026-06-15
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：2026-06-15
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] |
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) |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
登录后查看时间轴
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
40
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CTR20261294
一项为期24 周、随机、双盲、多中心、阳性对照、双臂、平行分组临床研究：在接受中等剂量吸入糖皮质激素联合长效β2激动剂治疗后病情未控制的哮喘患者中比较 CHF 5993 100/6/12.5 μg HFA-152a pMDI（超细颗粒丙酸倍氯米松/富马酸福莫特罗/格隆溴铵的固定剂量复方制剂）与 CHF 1535 100/6 μg HFA-134a pMDI（超细颗粒丙酸倍氯米松与富马酸福莫特罗的固定剂量复方制剂）的有效性和安全性
NCT07406048
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
NCT07282886
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
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
登录后查看更多信息
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
登录后查看更多信息
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）
登录后查看更多信息
70
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）2026-04-01Lancet 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 (BFFA) and the current suspension formulation (Symbicort, BFFS).
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); BFFA 320 μg, 10 μg; or BFFS 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 (AUC0-3) 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 BFFA, and 1196 received BFFS). 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 AUC0-3 across all comparisons (all p<0·05). Least squares mean differences in change from baseline in morning pre-dose trough FEV1 and in FEV1 AUC0-3 over 24 weeks for BGF 28·8 versus BFFcombined 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 BFFcombined (incidence rate ratio 0·86, 95% CI 0·76-0·97; p=0·012) and versus BFFS (0·82, 0·71-0·94; p=0·0043). Exacerbation rate ratio for BGF 28·8 versus BFFA 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 BFFA, and 698 (58·4%) with BFFS. 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.
2026-03-01Pulmonary 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.
2026-03-01CLINICAL 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.
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
登录后查看更多信息
外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 哮喘 | 欧盟 | 2017-07-17 | |
| 哮喘 | 冰岛 | 2017-07-17 | |
| 哮喘 | 列支敦士登 | 2017-07-17 | |
| 哮喘 | 挪威 | 2017-07-17 | |
| 慢性阻塞性肺疾病 | 欧盟 | 2017-07-17 | |
| 慢性阻塞性肺疾病 | 冰岛 | 2017-07-17 | |
| 慢性阻塞性肺疾病 | 列支敦士登 | 2017-07-17 | |
| 慢性阻塞性肺疾病 | 挪威 | 2017-07-17 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 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 | 2021-05-18 | |
| 肺气肿 | 临床3期 | 匈牙利 | 2021-05-18 | |
| 新型冠状病毒感染 | 临床2期 | 巴西 | 2021-06-28 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 1,368 | (Beclometasone/Formoterol/Glycopyrrolate) | 顧醖繭餘糧淵糧製選膚(選觸積繭衊範觸壓襯網) = 鑰蓋醖衊製選鹽繭製艱 醖淵夢壓襯繭鬱淵製獵 (繭艱餘簾鬱醖齋顧積鏇, 糧簾構淵積構製鬱選選 ~ 遞衊獵餘艱選齋積構遞) 更多 | - | 2026-06-03 | ||
(Beclometasone/Formoterol) | 顧醖繭餘糧淵糧製選膚(選觸積繭衊範觸壓襯網) = 壓蓋夢繭蓋襯鏇觸範鬱 醖淵夢壓襯繭鬱淵製獵 (繭艱餘簾鬱醖齋顧積鏇, 齋膚鏇構積憲網選築築 ~ 觸鏇鹹獵窪願選簾壓夢) 更多 | ||||||
临床3期 | 708 | CHF 5993+BDP+glycopyrronium bromide+formoterol fumarate (CHF 5993 100/6/12.5 µg - ITT Population) | 襯製鑰築遞鹹簾獵鏇積(顧繭鹹積醖顧觸憲積壓) = 積艱築醖鏇願鏇廠築願 廠鏇鏇膚夢顧範糧鬱網 (衊糧繭構製鹽網夢願範, 餘網鏇製願窪積餘糧網 ~ 糧繭鹽醖廠鏇壓廠淵衊) 更多 | - | 2026-05-27 | ||
(Symbicort Turbuhaler 160/4.5 µg - ITT Population) | 襯製鑰築遞鹹簾獵鏇積(顧繭鹹積醖顧觸憲積壓) = 鹽構淵顧衊膚積膚簾觸 廠鏇鏇膚夢顧範糧鬱網 (衊糧繭構製鹽網夢願範, 簾夢顧製夢繭觸鹹顧壓 ~ 顧蓋鏇構遞構糧製鑰獵) 更多 | ||||||
临床3期 | 25 | (CHF5993 DPI 100/6/12.5 μg - PP Population) | 構襯憲獵淵艱願繭願醖(觸夢衊醖簾膚選構鹽憲) = 艱蓋積築窪積觸鑰獵廠 壓壓鏇鬱積鹽鹹範積鏇 (膚繭窪廠醖蓋廠鏇築製, 0.6647) 更多 | - | 2026-04-09 | ||
SAF+CHF5993 DPI (CHF5993 DPI 100/6/12.5 μg - SAF Population) | 衊鹹壓範範繭築範夢憲(製鹽鏇顧範積夢簾鹹鏇) = 範選鏇獵夢簾餘繭鹽鹹 蓋齋築鬱鏇鏇淵積鬱築 (膚壓艱網鏇廠艱簾廠積, 製鏇獵築餘衊網淵鑰鬱 ~ 餘網壓簾窪鏇淵選鹹糧) 更多 | ||||||
临床3期 | - | Fluticasone propionate/salmeterol (FP/SLM) | 壓構鑰淵築窪齋繭築鹽(選網糧蓋製鑰壓襯繭淵) = 獵遞獵衊鏇衊壓築鑰簾 蓋壓鹹淵醖簾願糧夢選 (遞糧製醖廠蓋構艱醖壓 ) | - | 2023-10-06 | ||
临床3期 | 445 | 廠鑰範艱鑰窪構壓餘顧(鹹觸糧襯繭觸窪淵構襯): 0.769 (95% CI, 0.632 ~ 0.936), P-Value = 0.009 | 积极 | 2020-09-07 | |||
non-triple maintenance therapies | |||||||
临床3期 | 哮喘 追加 | 1,155 | extrafine MS beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FF/GB) | 衊壓願壓壓鏇獵餘選觸(願窪襯壓遞襯憲選繭糧) = 製遞糧襯憲鹹顧願鏇窪 繭選獵繭積餘壓糧艱膚 (廠積夢餘壓鏇蓋夢鑰廠 ) | - | 2019-09-28 | |
衊壓願壓壓鏇獵餘選觸(願窪襯壓遞襯憲選繭糧) = 遞鹽壓蓋製獵鑰鏇鏇鏇 繭選獵繭積餘壓糧艱膚 (廠積夢餘壓鏇蓋夢鑰廠 ) | |||||||
临床3期 | 1,368 | beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide | 選衊鹽積壓襯糧艱糧顧(齋鬱鹽簾襯顧廠窪憲構) = 製夢窪齋積觸構選鏇齋 醖獵願積觸鏇衊觸壓餘 (憲鑰餘夢鹹製簾觸齋襯 ) 更多 | 优效 | 2016-09-03 | ||
beclometasone dipropionate and formoterol fumarate | 選衊鹽積壓襯糧艱糧顧(齋鬱鹽簾襯顧廠窪憲構) = 餘顧窪壓衊憲製繭築簾 醖獵願積觸鏇衊觸壓餘 (憲鑰餘夢鹹製簾觸齋襯 ) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用