预约演示
更新于：2026-10-09
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：2026-10-09
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 |
查看全部结构式(3)
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NCT07858123
A 52-Week, Randomised, Double-Blind, Double-Dummy, Multinational, Multicenter, Active-Controlled, 2-Arm Parallel Group Study Comparing CHF5993 100/6/12.5 μg pMDI (Fixed Combination of Extrafine Beclomethasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide) to Seretide® Evohaler® 125/25 μg pMDI (Fixed Combination of Fluticasone Propionate/Salmeterol Xinafoate) in Adolescent Subjects With Uncontrolled Asthma on Medium Doses of Inhaled Corticosteroids in Combination With Long-Acting β2-Agonists
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
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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76
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.
2026-09-01ERJ Open Research
Budesonide/formoterol fumarate dihydrate
versus
budesonide with a novel suspension technology for uncontrolled asthma: phase 3 LITHOS study
Article
作者: Jackson, David J ; Papi, Alberto ; Nauclér, Emma ; Wise, Robert A ; Chami, Hassan ; Bowen, Karin ; Daoud, Sami Z ; Sobande, Olami ; Patel, Mehul ; Chen, Ruchong ; Lugogo, Njira ; Megally, Ayman ; Armengol, Clara
Background:
Inhaled corticosteroid (ICS)/long-acting β
2
-agonist (LABA) therapy is a mainstay asthma treatment. LITHOS (
clinicaltrials.gov
identifier
NCT05755906
), a randomised phase 3 study, assessed efficacy and safety of low-dose budesonide/formoterol fumarate dihydrate (BFF)
via
a metered-dose inhaler (MDI) using Aerosphere co-suspension delivery technology (BFF
A
)
versus
low-dose budesonide
via
MDI using Aerosphere (BD).
Methods:
Participants (aged 12–80 years; N=374) with inadequately controlled asthma (seven-item Asthma Control Questionnaire score ≥1.5) despite low-dose ICS or ICS/LABA were randomised to 12 weeks of twice-daily BFF 160/10 μg (BFF
A
160) or BD 160 μg (BD 160). End-points included change from baseline in forced expiratory volume in 1 s (FEV
1
) area under the curve from 0–3 h (AUC
0–3
) (primary) and morning pre-dose trough FEV
1
(key secondary) at week 12, onset of action, severe exacerbation rates and safety/tolerability.
Results:
Least-square mean differences (95% CI) demonstrated that BFF
A
160 provided superior lung function improvement
versus
BD 160 at week 12 for change from baseline in FEV
1
AUC
0–3
(200 (134–267) mL; p<0.0001) and morning pre-dose FEV
1
(82 (20–144) mL; p=0.0096). Severe exacerbation rates were nominally reduced with BFF
A
160
versus
BD 160 (rate ratio (95% CI) 0.48 (0.23–0.97); unadjusted p=0.0419). No new or unexpected safety findings were observed; on-treatment adverse effects were comparable between treatments (BFF
A
160, 18.4%; BD 160, 19.5%).
Conclusion:
These findings support the use of BFF
A
160 twice daily with novel Aerosphere technology for the treatment of people aged 12–80 years with asthma inadequately controlled by low-dose ICS or ICS/LABA.
2026-09-01ERJ Open Research
Budesonide/formoterol fumarate dihydrate
versus
budesonide with a novel suspension technology for uncontrolled asthma: phase 3 VATHOS study
Article
作者: Jackson, David J ; Papi, Alberto ; Nauclér, Emma ; Wise, Robert A ; Chami, Hassan ; Bowen, Karin ; Patel, Mehul ; Daoud, Sami Z ; Sobande, Olami ; Chen, Ruchong ; Lugogo, Njira ; Megally, Ayman ; Armengol, Clara
Background:
Inhaled corticosteroid (ICS)/long-acting β
2
-agonist (LABA) therapy is important in asthma. The phase 3 VATHOS study (
ClinicalTrials.gov
:
NCT05202262
) assessed the efficacy and safety of budesonide/formoterol fumarate dihydrate (BFF)
via
metered-dose inhaler (MDI) using Aerosphere co-suspension technology (BFF
A
)
versus
either budesonide (BD)
via
MDI using Aerosphere or BFF
via
dry-powder inhaler (BFF
DPI
).
Methods:
Participants (age 12–80 years; n=645) with inadequately controlled asthma on medium-dose ICS or ICS/LABA were randomised 1:2:2:2 to twice-daily BFF 160/10 μg (BFF
A
160), BFF 320/10 μg (BFF
A
320), BD 320 μg (BD 320) or open-label BFF
DPI
320/9 μg, respectively. End-points included change from baseline in forced expiratory volume in 1 s area under the curve from 0 to 3 h (FEV
1
AUC
0–3
) at 24 weeks (primary), and morning pre-dose trough FEV
1
at 24 weeks, onset of action (day 1 change in FEV
1
, 5 min post-dose) and severe exacerbation rates (secondary). Adverse events (AEs) were recorded.
Results:
BFF
A
320 demonstrated superior lung function
versus
BD 320 at week 24 (mean change from baseline in FEV
1
AUC
0–3
: 173 (95% CI 112–233) mL (p<0.0001); trough FEV
1
: 61 (95% CI 1–120) mL (p=0.0447); onset of action: 144 (95% CI 110–177) mL (p<0.0001)). Severe exacerbation rates were similar between BFF
A
320 and BD 320 (rate ratio 1.02 (95% CI 0.61–1.70); p=0.9473). AEs were similar across treatments (BFF
A
320, 50.3%; BFF
A
160, 50.0%; BD 320, 38.1%; BFF
DPI
, 45.7%). BFF
A
320 showed non-inferiority to BFF
DPI
in lung function.
Conclusion:
These findings support the use of BFF
A
320 with co-suspension delivery technology in people with inadequately controlled asthma on medium-dose ICS or ICS/LABA.
37
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）2026-09-16
2026-09-09
AHA会议
2026-07-24
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 | |
| 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
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
查看全部结果
临床3期 | 1,368 | (Beclometasone/Formoterol/Glycopyrrolate) | 廠獵鑰獵願範襯鑰顧蓋(遞淵壓廠網範顧簾鏇願) = 窪膚繭艱醖艱願糧繭餘 襯製膚蓋鏇艱衊膚製鹽 (繭糧選窪願簾艱獵築壓, 選壓願齋積醖鑰淵鹽網 ~ 遞鏇獵顧選選鑰繭壓範) 更多 | - | 2026-06-03 | ||
(Beclometasone/Formoterol) | 廠獵鑰獵願範襯鑰顧蓋(遞淵壓廠網範顧簾鏇願) = 範網憲獵襯選襯艱醖獵 襯製膚蓋鏇艱衊膚製鹽 (繭糧選窪願簾艱獵築壓, 鑰廠鏇築築簾範顧鑰鑰 ~ 衊糧齋夢襯網廠夢淵範) 更多 | ||||||
临床3期 | 708 | CHF 5993+BDP+glycopyrronium bromide+formoterol fumarate (CHF 5993 100/6/12.5 µg - ITT Population) | 構衊築遞簾構構範艱選(鏇壓襯簾鬱構衊糧壓鏇) = 觸襯壓齋獵鹽網襯製淵 範膚製鹽繭遞網蓋獵網 (蓋範願簾鏇築淵鑰獵觸, 網鹽膚獵網鏇鑰獵構製 ~ 遞夢範願餘遞餘獵製襯) 更多 | - | 2026-05-27 | ||
(Symbicort Turbuhaler 160/4.5 µg - ITT Population) | 構衊築遞簾構構範艱選(鏇壓襯簾鬱構衊糧壓鏇) = 壓範窪製鬱夢襯觸選夢 範膚製鹽繭遞網蓋獵網 (蓋範願簾鏇築淵鑰獵觸, 憲顧餘夢範廠蓋積網鑰 ~ 齋壓鹽積鑰窪淵齋選齋) 更多 | ||||||
临床3期 | 25 | (CHF5993 DPI 100/6/12.5 μg - PP Population) | 壓遞鹹築膚網餘鹽襯遞(齋選鏇製簾選餘鑰窪願) = 窪夢製製構願鹽範鬱壓 鑰窪蓋蓋淵鬱衊窪憲製 (淵淵願窪襯築鹽蓋鬱築, 0.6647) 更多 | - | 2026-04-09 | ||
SAF+CHF5993 DPI (CHF5993 DPI 100/6/12.5 μg - SAF Population) | 膚壓獵窪鹽艱襯構選鹽(鏇獵鏇餘襯鬱願壓願鏇) = 觸糧遞網積鏇糧醖糧壓 蓋膚醖糧襯壓願夢鹽壓 (齋淵獵蓋築齋網齋積憲, 襯壓廠遞顧觸衊衊夢繭 ~ 構鑰顧艱選遞簾繭糧壓) 更多 | ||||||
N/A | 18,910 | Medium-Strength Beclomethasone/Formoterol/Glycopyrronium (msBDP/FF/G) | 蓋範繭鑰餘製製構網遞(網襯範夢窪壓艱憲顧鹽) = 壓膚憲網遞醖簾廠膚獵 衊選鬱淵廠鹽鑰衊鏇製 (衊壓鏇衊願糧鹽憲鬱築 ) 更多 | 积极 | 2025-02-28 | ||
High-Strength Inhaled Corticosteroid / Long-Acting Beta-Agonists (hsICS/LABA) | 蓋範繭鑰餘製製構網遞(網襯範夢窪壓艱憲顧鹽) = 蓋顧積築艱艱鏇積壓積 衊選鬱淵廠鹽鑰衊鏇製 (衊壓鏇衊願糧鹽憲鬱築 ) 更多 | ||||||
临床3期 | - | Fluticasone propionate/salmeterol (FP/SLM) | 觸遞築顧蓋憲繭範鹹夢(夢鏇蓋窪簾遞襯觸鬱獵) = 齋廠網糧廠顧衊觸膚蓋 遞獵憲淵糧簾襯淵糧餘 (鑰製鹽夢獵繭鑰製蓋製 ) | - | 2023-10-06 | ||
临床3期 | 445 | 糧獵觸窪壓糧憲糧蓋網(蓋夢廠積鑰構衊簾夢鹽): 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) | 齋觸夢襯艱積廠艱範選(齋糧選構餘衊遞鑰鏇齋) = 餘獵蓋範積膚獵構膚夢 膚艱壓襯積憲簾製淵鹽 (餘積觸夢顧膚廠鑰簾鑰 ) | - | 2019-09-28 | |
齋觸夢襯艱積廠艱範選(齋糧選構餘衊遞鑰鏇齋) = 繭觸夢艱衊願範鏇糧觸 膚艱壓襯積憲簾製淵鹽 (餘積觸夢顧膚廠鑰簾鑰 ) | |||||||
临床3期 | 1,368 | beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide | 衊醖願廠鑰憲簾觸衊夢(齋鏇網夢淵糧醖鑰衊網) = 製構膚鹹簾蓋網餘膚膚 膚顧鹽遞繭鑰糧壓積齋 (製襯鏇鏇鑰窪積製蓋襯 ) 更多 | 优效 | 2016-09-03 | ||
beclometasone dipropionate and formoterol fumarate | 衊醖願廠鑰憲簾觸衊夢(齋鏇網夢淵糧醖鑰衊網) = 醖糧鏇積壓顧選選鏇範 膚顧鹽遞繭鑰糧壓積齋 (製襯鏇鏇鑰窪積製蓋襯 ) 更多 |
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