预约演示
更新于：2026-01-27
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：2026-01-27
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 |
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NCT07301736
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
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
CTIS2024-514248-95-00
A 52 week, randomized, double-blind, double dummy multinational, multicenter, active controlled, 2-arm parallel group trial comparing CHF 5993 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 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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64
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）2025-11-01ERJ Open Research
Effect of budesonide/glycopyrronium/formoterol fumarate dihydrate on cardiopulmonary outcomes in COPD: rationale and design of the THARROS trial
Article
作者: Berg, David D ; Arya, Niki ; Fredriksson, Martin ; Lam, Carolyn S P ; Bowen, Karin ; Price, David ; Cowie, Martin R ; Bafadhel, Mona ; Zheng, Jinping ; Patel, Mehul ; Hurst, John R ; Martinez, Fernando J ; Mushunje, Alec ; Pszczol, Michel ; Han, MeiLan K
Background:
COPD and cardiovascular disease (CVD) are leading causes of death with overlapping and syndemic pathophysiological interactions. Inhaled triple therapies containing inhaled corticosteroids (ICS), long-acting muscarinic antagonists (LAMA) and long-acting β
2
-agonists (LABA) reduce COPD exacerbation rates and improve lung function
versus
dual LAMA/LABA therapy. The effect of inhaled triple therapies on combined cardiac and pulmonary (
i.e.
, cardiopulmonary) events in people with COPD and elevated cardiopulmonary risk has not been prospectively tested in randomised clinical trials.
Methods:
THARROS is a multinational, event-driven cardiopulmonary outcomes trial evaluating budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) triple therapy
versus
glycopyrronium/formoterol fumarate dihydrate dual therapy in patients with COPD and elevated cardiopulmonary risk not using ICS-containing maintenance therapy. Eligibility requirements include symptomatic COPD (COPD Assessment Test scores ≥10) without a requirement for prior COPD exacerbations, blood eosinophils ≥100 cells·mm
−3
, established CVD or CVD risk based on clinical characteristics, clinical risk scores or imaging-based risk criteria. The composite primary end-point is time to first severe cardiac or COPD event and includes three event types, including severe cardiac events (heart failure acute healthcare visit/hospitalisation, myocardial infarction hospitalisation), severe COPD exacerbations and cardiopulmonary death. Approximately 5000 patients will be randomised to achieve 632 participants with ≥1 primary severe adjudicated cardiopulmonary event.
Conclusion:
This first-of-its-kind cardiopulmonary outcomes trial will determine the effect of BGF on a novel composite end-point comprising severe cardiopulmonary events in a broad COPD population with elevated cardiopulmonary risk not currently using ICS-containing maintenance therapy.
2025-11-01ERJ Open Research
Short-acting β
2
-agonist use, exacerbation risk and triple therapy in COPD:
post hoc
analyses of ETHOS
Article
作者: Movitz, Charlotta ; Darken, Patrick ; Martinez, Fernando J ; Hurst, John R ; Singh, Dave ; Arya, Niki ; Patel, Mehul ; Rabe, Klaus F ; Bowen, Karin
Background:
Short-acting β
2
-agonist (SABA) rescue therapy can relieve COPD symptoms. We assessed post-randomisation treatment effects on exacerbations and health-related quality of life in ETHOS by rescue SABA use.
Methods:
In ETHOS (
NCT02465567
), symptomatic people with COPD and an exacerbation history were randomly assigned 1:1:1:1 to budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) (320/14.4/10 or 160/14.4/10 μg), glycopyrronium/formoterol fumarate dihydrate (GFF) (14.4/10 μg) or budesonide/formoterol fumarate dihydrate (BFF) (320/10 μg).
Post hoc
analyses assessed exacerbation rates by baseline and post-randomisation SABA use (>4
versus
≤4 inhalations·day
−1
), St George's Respiratory Questionnaire change from baseline by post-randomisation SABA use (>4
versus
≤4 inhalations·day
−1
), and post-randomisation SABA use surrounding (30 days before, day of onset, 30 days after) the first exacerbation.
Results:
Across treatments, higher moderate/severe exacerbation rates were observed for participants with higher (range: 1.62–2.51)
versus
lower (range: 1.14–1.51) SABA use at baseline or post-randomisation. Post-randomisation SABA use increased in the 30 days preceding, and decreased in the 30 days following, an exacerbation. Evidence of BGF benefit
versus
dual therapies in reducing moderate/severe exacerbation rates were seen regardless of SABA use level at baseline or post-randomisation, with greater BGF benefit observed
versus
GFF with higher SABA use (rate ratios (95% CI): high baseline SABA, 0.62 (0.53–0.72); high post-randomisation SABA, 0.64 (0.54–0.76)).
Conclusion:
These results suggest increased SABA use is associated with an impending exacerbation. Further, BGF reduces exacerbation rates regardless of SABA use, with greater benefit in those with higher SABA use.
2025-09-01EClinicalMedicine
Safety of budesonide/glycopyrronium/formoterol fumarate dihydrate delivered by HFO-1234ze versus HFA-134a in chronic obstructive pulmonary disease: a phase 3, multi-site, randomised, double-blind, parallel-group, active-comparator study
Article
作者: Mei, Jie ; Bell, Jennifer L ; Kucz, Kinga ; Pandya, Hitesh ; Camiolo, Matthew ; Jassal, Mandeep ; Patel, Mehul ; Bondarov, Patrik ; Collison, Kathryn ; Pettersson, Lars ; Skansen, Karin ; Kokot, Marek ; Martinez, Fernando J ; Usmani, Omar S ; Bednarczyk, Artur ; Petullo, David ; Aurivillius, Magnus ; Gottfridsson, Christer
Background:
Pressurised metered dose inhalers (pMDIs) contain a hydrofluorocarbon propellant, such as hydrofluoroalkane-134a (HFA-134a), which is known to have global warming potential (GWP). Transitioning pMDIs to propellants with lower GWP will reduce the environmental impact of pMDIs. This study assessed the safety of a near-zero GWP propellant, hydrofluoroolefin-1234ze (HFO-1234ze), compared with HFA-134a when used in the delivery of budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) in participants with chronic obstructive pulmonary disease (COPD). The results of this study advance our understanding of the safety of HFO-1234ze compared with HFA-134a.
Methods:
This phase 3, double-blind, parallel-group study (ClinicalTrials.govNCT05573464) across 9 countries (Argentina, Bulgaria, Canada, Germany, Mexico, Poland, Turkey, the United Kingdom, the United States) included participants (aged 40-80 years) with physician-diagnosed COPD using dual or triple inhaled maintenance therapies, COPD Assessment Test score ≥10, ≥10 pack-years smoking history, and no comorbid diagnosis of asthma or other clinically significant diseases impacting study outcomes. Participants were randomised (1:1) to receive either BGF HFO-1234ze or BGF HFA-134a (two inhalations of 160/7·2/5·0 μg twice daily) for 12 weeks in the main safety analysis set (or 52 weeks [first 120 participants per treatment]). Safety endpoints included the incidence of adverse events (AEs), measures of vital signs, clinical laboratory tests, and electrocardiograms.
Findings:
Participants were recruited between 27 September 2022 and 19 May 2023. A total of 874 participants were screened. Of 558 treated participants (mean [standard deviation] age, 67·0 [7·4] years; male, 315 [56·5%]) in the 12-week safety analysis set, 280 received BGF HFO-1234ze, and 278 received BGF HFA-134a. The AE incidence was balanced between formulations in the 12-week (HFO-1234ze, 124 [44·3%]; HFA-134a, 114 [41·0%]) and 52-week (HFO-1234ze, 80 [66·7%]; HFA-134a, 94 [78·3%]) safety analysis sets.
Interpretation:
These findings support the potential for HFO-1234ze to replace HFA-134a in pMDIs containing BGF, which could be evaluated further in a real-world setting.
Funding:
The study was supported by 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 | |
| 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 | 2021-05-25 | |
| 肺气肿 | 临床3期 | 匈牙利 | 2021-05-25 | |
| 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 | - | Fluticasone propionate/salmeterol (FP/SLM) | 網遞壓糧憲製範窪齋鹹(繭顧餘窪繭糧鹽範願網) = 鹽網淵膚餘醖製醖網糧 窪簾衊餘顧淵糧膚淵窪 (選蓋獵膚夢壓壓鑰糧鹽 ) | - | 2023-10-06 | ||
临床3期 | 445 | 獵顧簾繭鹽鑰製積願築(選繭繭構觸衊積鏇鹹夢): 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) | 鹽廠壓鏇製網廠鑰廠淵(窪鏇製鹹顧獵襯餘窪齋) = 繭醖網願觸築夢構鹽齋 製積淵壓糧繭淵鑰艱廠 (餘鬱積鹽糧衊鏇廠襯遞 ) | - | 2019-09-28 | |
鹽廠壓鏇製網廠鑰廠淵(窪鏇製鹹顧獵襯餘窪齋) = 憲鬱鹽願醖衊鬱窪觸繭 製積淵壓糧繭淵鑰艱廠 (餘鬱積鹽糧衊鏇廠襯遞 ) | |||||||
临床3期 | 1,368 | beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide | 獵壓願範鏇範範艱範繭(鏇範齋醖壓鬱夢蓋餘窪) = 廠觸廠襯築襯鏇醖蓋選 襯艱遞齋願鬱夢觸觸齋 (淵選選網選醖壓夢齋繭 ) 更多 | 优效 | 2016-09-03 | ||
beclometasone dipropionate and formoterol fumarate | 獵壓願範鏇範範艱範繭(鏇範齋醖壓鬱夢蓋餘窪) = 鹹選鏇選鹹網築繭製範 襯艱遞齋願鬱夢觸觸齋 (淵選選網選醖壓夢齋繭 ) 更多 |
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