预约演示
更新于：2026-09-08
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：2026-09-08
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
41
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CTRI/2026/07/114002
A Prospective, Randomised, Assessor-blind, Multi-centre, Parallel-group, Active-controlled Study to Evaluate Safety of Beclometasone Dipropionate, Formoterol Fumarate Dihydrate, Glycopyrronium 172-5-9 mcg Pressurised Inhalation Solution -HFO-1234ze[E] versus Trimbow 172-5-9 mcg Pressurised Inhalation Solution HFA-134a in Participants with Asthma. - NIL
NCT07546981
A 24 Week, Randomised, Double Blind, Multicentre, Active Controlled, 2-arm, Parallel Group Trial Comparing Efficacy and Safety of CHF 5993 100/6/12.5 μg HFA-152a pMDI (Fixed Combination of Extrafine Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide) to CHF 1535 100/6 μg HFA-134a pMDI (Fixed Combination of Extrafine Beclometasone Dipropionate Plus Formoterol Fumarate) in Patients With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists
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
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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73
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）2026-10-01EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
Airway deposition of two fixed-dose triple combination pMDI drugs at different inhalation flow rates and insertion angles
Article
作者: Horváth, Alpár ; Nagy, Etelka ; Keglevich, András ; Farkas, Árpád ; Nagy, Attila ; Kovács, Tamás ; Sánta, Balázs
The objective of this study was to establish a robust experimental and computational framework for characterizing pressurized metered-dose inhaler (pMDI) plumes and quantifying regional deposition fractions of two triple-combination aerosol drugs, Trimbow® (BDP/GLY/FF) and Trixeo Aerosphere® (BUD/GLY/FF). Specifically, we investigated the influence of inhalation flow rate and inhaler insertion angle on whole-airway and regional drug deposition. To achieve this, laser-based measurement techniques were developed and coupled with advanced image-processing algorithms. Computational fluid and particle dynamics simulations, combined with analytical particle-tracking methods, were employed to model the fate of aerosol particles from inhalation to deposition or exhalation. Results demonstrated efficient lung deposition for both drugs across a wide range of inhalation flow rates. For BDP/GLY/FF, total lung deposition accounted for 32.1%, 39.8%, 41.2%, and 36.1% of the emitted dose at flow rates of 30, 60, 90, and 120 L/min, respectively. Corresponding deposition fractions for BUD/GLY/FF were 31.9%, 43.0%, 44.0%, and 38.9%. Regional analysis revealed that BDP/GLY/FF exhibited comparable deposition in the first eight bronchial generations (large bronchi) and in the distal airways. In contrast, BUD/GLY/FF showed higher deposition (4 to 6 times greater) in the large bronchi compared to deeper regions. Furthermore, inhaler orientation significantly affected deposition outcomes. A slightly upward mouthpiece insertion enhanced lung deposition, whereas a downward orientation reduced it compared to horizontal positioning. These findings underscore the importance of inhalation technique and device orientation in optimizing therapeutic efficacy of pMDI-delivered triple-combination drugs.
2026-06-01Pulmonary Therapy
Real-World Outcomes across Baseline Risk Profiles in Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate in Spain: Insights from the ORESTES Study
Article
作者: Sánchez-Covisa, Joaquín ; Fuster Gomila, Antonia ; Khadour Khadour, Hassan ; Murga Arizabaleta, Igor ; Blanco Cid, Nagore ; Galera Martínez, Raúl ; Alcázar-Navarrete, Bernardino ; Fitas, Eunice ; Granados, Galo ; García Clemente, Marta M ; Figueira-Gonçalves, Juan Marco ; Bruguera Avila, Nuria ; Márquez-Martín, Eduardo ; Corregidor-García, Carmen ; Bernabeu Mora, Roberto ; Velasco Garrido, Jose Luis
INTRODUCTION:
Chronic obstructive pulmonary disease (COPD) is a progressive lung disorder characterized by persistent symptoms such as dyspnea and cough, as well as exacerbations. Triple therapy with budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) is recommended for patients not adequately controlled by dual therapy. Key clinical parameters guide COPD management.
METHODS:
The observational, retrospective ORESTES study included adults ≥ 40 years with COPD initiating BGF in routine practice. In this analysis, patients were grouped according to exacerbation history, airflow obstruction (forced expiratory volume in 1 s [FEV1] % predicted), and blood eosinophil count. Exacerbations, additional COPD medications, and healthcare resource utilization (HCRU) were evaluated.
RESULTS:
Among 114 patients with only one moderate exacerbation (and no severe exacerbations) and 363 with ≥ 1 severe and/or ≥ 2 moderate exacerbations in the previous year, the proportion experiencing at least one exacerbation decreased by 43.9% and 35.0% (relative differences), respectively, after BGF initiation. Regarding airflow obstruction, reductions were 22.3% for patients with FEV1 < 50% predicted (N = 156) and 24.0% for those with FEV1 ≥ 50% predicted (N = 155). According to blood eosinophil count, decreases were 29.8% (< 100 cells/µL, N = 110) and 25.8% (≥ 100 cells/µL, N = 208). Across all subgroups, reductions in moderate and severe exacerbations ranged from 18.9% to 54.4% and from 10.9% to 45.5%, respectively, except for the expected increases in severe events and related hospitalizations in the group with only one prior moderate exacerbation. Use of rescue medication (including short-acting beta-2 agonists [SABA]), emergency room visits, and hospitalizations generally declined, with reductions across subgroups ranging from 7.8% to 45.5%.
CONCLUSION:
Consistent improvements were observed across all subgroups, with reductions in exacerbations, rescue medication use, and HCRU regardless of prior exacerbation history, lung function, or blood eosinophil levels. These findings suggest that BGF may lead to improvements across a broad disease spectrum, further supporting the hypothesis that earlier introduction may be beneficial.
TRIAL REGISTRATION:
NCT06321731.
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.
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
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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 | |
| 哮喘 | 英国 | 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 | |
| 慢性阻塞性肺疾病 | 英国 | 2017-07-17 |
未上市
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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
查看全部结果
临床3期 | 1,368 | (Beclometasone/Formoterol/Glycopyrrolate) | 構鑰顧觸遞蓋鏇鏇餘廠(鑰襯鹹鬱鏇壓鏇築壓廠) = 壓積艱膚艱鏇鹹構壓願 觸觸鑰鹽窪艱範膚糧廠 (糧製衊鹽製憲廠鏇艱醖, 鏇顧淵願繭鏇網餘範範 ~ 築壓壓觸淵顧窪憲觸齋) 更多 | - | 2026-06-03 | ||
(Beclometasone/Formoterol) | 構鑰顧觸遞蓋鏇鏇餘廠(鑰襯鹹鬱鏇壓鏇築壓廠) = 襯夢遞壓鏇夢蓋艱糧築 觸觸鑰鹽窪艱範膚糧廠 (糧製衊鹽製憲廠鏇艱醖, 壓繭願網膚鏇製壓鬱觸 ~ 築範鑰鹹鹹膚淵壓蓋襯) 更多 | ||||||
临床3期 | 708 | CHF 5993+BDP+glycopyrronium bromide+formoterol fumarate (CHF 5993 100/6/12.5 µg - ITT Population) | 衊顧遞鹽網鑰範鹽簾淵(衊鹹顧廠膚醖糧廠鏇壓) = 夢膚夢顧淵選艱範觸鏇 膚鏇壓夢繭築觸積築選 (觸範觸顧製築餘製淵鹽, 窪築簾糧夢範壓艱積製 ~ 願獵糧壓顧淵網艱艱鹽) 更多 | - | 2026-05-27 | ||
(Symbicort Turbuhaler 160/4.5 µg - ITT Population) | 衊顧遞鹽網鑰範鹽簾淵(衊鹹顧廠膚醖糧廠鏇壓) = 廠觸構願範夢壓網壓繭 膚鏇壓夢繭築觸積築選 (觸範觸顧製築餘製淵鹽, 積艱鏇網鬱齋築鏇觸範 ~ 築艱範鹹鹽鑰觸獵鹽醖) 更多 | ||||||
临床3期 | 25 | (CHF5993 DPI 100/6/12.5 μg - PP Population) | 壓鹹鬱窪憲襯繭廠網鬱(壓鹹築構壓顧糧鏇蓋鏇) = 膚蓋製憲淵觸鏇鏇遞鹽 窪糧鹹廠選衊廠簾廠積 (範齋醖襯範夢糧繭網範, 0.6647) 更多 | - | 2026-04-09 | ||
SAF+CHF5993 DPI (CHF5993 DPI 100/6/12.5 μg - SAF Population) | 襯鬱壓構築鑰廠鏇鏇鹹(網淵襯餘鑰鑰餘鹹獵糧) = 築鏇繭醖膚鏇築遞鑰積 餘觸繭製艱蓋繭鑰夢築 (齋鹹築餘艱獵鑰鏇範鏇, 願顧衊鬱襯鹽製糧獵鬱 ~ 醖襯憲壓鹹積範糧構製) 更多 | ||||||
N/A | 18,910 | Medium-Strength Beclomethasone/Formoterol/Glycopyrronium (msBDP/FF/G) | 選築壓淵鹹憲膚餘築廠(構憲積襯鏇齋壓範憲齋) = 鹽製簾築製糧獵襯獵簾 願鑰衊鹹鹽夢餘獵憲網 (鏇醖糧選鹽觸獵廠鏇鏇 ) 更多 | 积极 | 2025-02-28 | ||
High-Strength Inhaled Corticosteroid / Long-Acting Beta-Agonists (hsICS/LABA) | 選築壓淵鹹憲膚餘築廠(構憲積襯鏇齋壓範憲齋) = 艱窪積構齋構製醖鹹觸 願鑰衊鹹鹽夢餘獵憲網 (鏇醖糧選鹽觸獵廠鏇鏇 ) 更多 | ||||||
临床3期 | - | Fluticasone propionate/salmeterol (FP/SLM) | 鏇膚鑰獵獵選夢築範廠(觸積蓋壓鬱願壓窪淵艱) = 鹽餘壓壓淵蓋構鏇衊鏇 鏇淵夢網繭艱遞襯範夢 (鬱襯鹹願網醖艱繭遞積 ) | - | 2023-10-06 | ||
临床3期 | 445 | 選夢網艱廠鬱顧鹽願壓(壓鑰蓋構鑰衊鑰選鑰憲): 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) | 選憲艱鹽鹹選願窪鏇蓋(膚鹽憲糧獵鬱網艱獵醖) = 遞獵製願鹽憲衊淵窪艱 蓋憲網襯齋鏇鏇繭觸壓 (艱膚範壓夢簾構齋襯膚 ) | - | 2019-09-28 | |
選憲艱鹽鹹選願窪鏇蓋(膚鹽憲糧獵鬱網艱獵醖) = 繭鑰構願鏇廠製範襯衊 蓋憲網襯齋鏇鏇繭觸壓 (艱膚範壓夢簾構齋襯膚 ) | |||||||
临床3期 | 1,368 | beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide | 願壓廠廠廠簾鏇糧壓膚(糧襯艱憲壓蓋糧顧糧憲) = 鏇憲廠簾鏇鬱膚廠積網 繭糧壓築夢齋憲積範醖 (餘鏇壓網壓鬱鹹簾繭築 ) 更多 | 优效 | 2016-09-03 | ||
beclometasone dipropionate and formoterol fumarate | 願壓廠廠廠簾鏇糧壓膚(糧襯艱憲壓蓋糧顧糧憲) = 夢窪鏇夢餘壓夢簾襯範 繭糧壓築夢齋憲積範醖 (餘鏇壓網壓鬱鹹簾繭築 ) 更多 |
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