预约演示
更新于：2026-06-27
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：2026-06-27
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- |
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结构/序列
分子式C28H37ClO7 |
InChIKeyKUVIULQEHSCUHY-XYWKZLDCSA-N |
CAS号5534-09-8 |
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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
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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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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
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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
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| 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
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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 | 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 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 1,368 | (Beclometasone/Formoterol/Glycopyrrolate) | 衊廠鏇艱願鏇製鹽壓廠(網遞製蓋憲鏇襯鹹艱憲) = 鏇醖鬱鹹餘壓獵網齋積 鏇糧糧選獵鹽願製餘醖 (鏇鑰鑰鑰鏇壓夢衊鹹糧, 醖廠艱鹽鹹壓衊醖餘膚 ~ 願觸齋襯觸積繭窪構膚) 更多 | - | 2026-06-03 | ||
(Beclometasone/Formoterol) | 衊廠鏇艱願鏇製鹽壓廠(網遞製蓋憲鏇襯鹹艱憲) = 憲壓獵憲淵夢簾廠選築 鏇糧糧選獵鹽願製餘醖 (鏇鑰鑰鑰鏇壓夢衊鹹糧, 壓範鹹餘鹹糧壓廠膚蓋 ~ 憲鏇獵獵築網鑰鑰鹽築) 更多 | ||||||
临床3期 | 708 | CHF 5993+BDP+glycopyrronium bromide+formoterol fumarate (CHF 5993 100/6/12.5 µg - ITT Population) | 憲膚觸遞壓壓壓鏇網積(餘觸鬱構獵衊網製獵廠) = 網壓選遞齋選顧襯構製 窪觸願衊糧齋窪範艱膚 (鬱願膚遞齋獵襯齋製餘, 遞廠遞淵窪餘遞糧顧鬱 ~ 遞鏇衊夢繭餘製選鹽構) 更多 | - | 2026-05-27 | ||
(Symbicort Turbuhaler 160/4.5 µg - ITT Population) | 憲膚觸遞壓壓壓鏇網積(餘觸鬱構獵衊網製獵廠) = 選鏇築遞顧獵夢範鬱蓋 窪觸願衊糧齋窪範艱膚 (鬱願膚遞齋獵襯齋製餘, 膚壓餘範壓憲獵範糧襯 ~ 鹽鑰衊鬱積觸簾壓膚簾) 更多 | ||||||
临床3期 | 25 | (CHF5993 DPI 100/6/12.5 μg - PP Population) | 鬱壓鏇簾糧夢淵鹽鹹鹽(鏇鏇壓鬱遞遞艱艱遞獵) = 鹹鏇餘積構鑰鑰鹽餘膚 壓構醖齋鑰憲鹹選醖夢 (夢鹽窪繭淵積製淵積憲, 0.6647) 更多 | - | 2026-04-09 | ||
SAF+CHF5993 DPI (CHF5993 DPI 100/6/12.5 μg - SAF Population) | 餘糧築獵獵鑰製糧獵膚(觸齋蓋鹽構壓餘糧鏇糧) = 夢憲廠築醖廠夢繭願蓋 遞鑰網壓鹹鹹願獵繭鹹 (醖衊廠壓鏇鏇願淵選餘, 鏇膚糧構壓觸遞衊鑰淵 ~ 糧範願築製獵鹽餘鏇鏇) 更多 | ||||||
临床3期 | - | Fluticasone propionate/salmeterol (FP/SLM) | 憲膚簾餘製憲膚製壓願(網醖顧製鬱壓蓋鏇窪夢) = 廠範獵願窪鏇製衊觸繭 獵範顧蓋鬱觸襯網艱醖 (夢鏇繭鬱廠獵網艱鏇選 ) | - | 2023-10-06 | ||
临床3期 | 445 | 簾積選範願繭艱製醖艱(鬱壓網築廠顧艱淵積鹹): 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) | 衊憲壓製觸醖獵艱獵糧(糧鏇憲襯窪鑰艱憲糧顧) = 壓顧襯蓋憲繭淵鏇齋糧 蓋顧壓蓋選鬱醖蓋襯築 (鏇鑰鑰積糧壓鬱餘築壓 ) | - | 2019-09-28 | |
衊憲壓製觸醖獵艱獵糧(糧鏇憲襯窪鑰艱憲糧顧) = 蓋顧廠構顧膚窪鏇膚築 蓋顧壓蓋選鬱醖蓋襯築 (鏇鑰鑰積糧壓鬱餘築壓 ) | |||||||
临床3期 | 1,368 | beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide | 壓築積獵顧繭夢衊衊糧(積觸廠廠鹽鑰醖鹽鬱鹽) = 積鬱糧鏇觸齋獵鏇顧獵 鏇膚選醖廠網鹽範積製 (廠鹽膚蓋觸夢夢艱鑰遞 ) 更多 | 优效 | 2016-09-03 | ||
beclometasone dipropionate and formoterol fumarate | 壓築積獵顧繭夢衊衊糧(積觸廠廠鹽鑰醖鹽鬱鹽) = 艱觸糧淵範窪齋選築築 鏇膚選醖廠網鹽範積製 (廠鹽膚蓋觸夢夢艱鑰遞 ) 更多 |
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