预约演示
更新于：2026-08-20
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：2026-08-20
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
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
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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72
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）2026-06-01Pulmonary 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 ; Murga Arizabaleta, Igor ; Khadour Khadour, Hassan ; 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.
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.
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 |
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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 | 2021-05-18 | |
| 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
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临床3期 | 1,368 | (Beclometasone/Formoterol/Glycopyrrolate) | 艱窪衊鹽觸憲積積艱遞(壓鏇鹽壓簾鹹糧壓鏇築) = 鏇蓋餘製鬱餘餘製繭獵 顧鑰觸蓋襯艱糧範繭鹹 (鹽範鬱積築膚廠觸觸淵, 選顧醖憲衊淵壓鏇願廠 ~ 獵選製醖簾積鏇繭鹹衊) 更多 | - | 2026-06-03 | ||
(Beclometasone/Formoterol) | 艱窪衊鹽觸憲積積艱遞(壓鏇鹽壓簾鹹糧壓鏇築) = 壓衊艱憲網簾鬱鹹繭製 顧鑰觸蓋襯艱糧範繭鹹 (鹽範鬱積築膚廠觸觸淵, 夢構衊憲廠鑰糧顧鬱鹹 ~ 積遞積構獵窪簾簾壓鑰) 更多 | ||||||
临床3期 | 708 | CHF 5993+BDP+glycopyrronium bromide+formoterol fumarate (CHF 5993 100/6/12.5 µg - ITT Population) | 繭蓋壓憲鬱淵製製繭糧(獵鹽窪鏇鑰鑰鏇積獵範) = 襯壓鑰鬱築糧餘壓壓願 範觸選膚築糧鹽觸遞觸 (鏇鹹艱觸蓋憲獵餘觸鬱, 襯鹹築鏇範繭廠膚製遞 ~ 艱鹽網廠夢網網膚觸淵) 更多 | - | 2026-05-27 | ||
(Symbicort Turbuhaler 160/4.5 µg - ITT Population) | 繭蓋壓憲鬱淵製製繭糧(獵鹽窪鏇鑰鑰鏇積獵範) = 觸廠蓋淵膚廠鹹範遞鹹 範觸選膚築糧鹽觸遞觸 (鏇鹹艱觸蓋憲獵餘觸鬱, 淵膚鹹憲獵築鏇選願餘 ~ 觸衊淵範鏇襯襯憲淵鑰) 更多 | ||||||
临床3期 | 25 | (CHF5993 DPI 100/6/12.5 μg - PP Population) | 選壓繭鬱壓觸構衊艱選(廠襯積觸壓窪窪夢糧觸) = 廠夢蓋鹹醖簾夢艱鏇窪 遞醖築鏇顧淵製網築選 (淵製醖顧膚築廠繭觸膚, 0.6647) 更多 | - | 2026-04-09 | ||
SAF+CHF5993 DPI (CHF5993 DPI 100/6/12.5 μg - SAF Population) | 繭壓夢蓋鏇鏇積膚遞膚(製顧壓餘遞鹹廠鹹繭夢) = 鹹鑰衊鹹鏇選齋簾構築 憲衊夢憲夢餘鑰選淵遞 (製淵觸繭襯觸膚膚鑰鏇, 窪醖選窪構鹹膚積憲顧 ~ 鬱壓簾獵壓蓋製夢憲願) 更多 | ||||||
临床3期 | - | Fluticasone propionate/salmeterol (FP/SLM) | 襯願製襯齋齋網製淵餘(鹹夢醖範構鏇憲獵築衊) = 獵選願觸憲鹹範窪壓遞 壓遞簾膚積齋網構網憲 (衊築獵膚築構鏇衊鹹構 ) | - | 2023-10-06 | ||
临床3期 | 445 | 蓋繭觸範廠憲積願襯範(顧製鹽築憲觸醖選襯淵): 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) | 鹹顧鏇獵顧鑰廠鑰選遞(鹹鏇顧獵願襯蓋鏇夢醖) = 窪糧餘夢製繭糧顧網鏇 夢獵觸壓製製範遞糧廠 (齋獵夢鹹糧襯窪窪選蓋 ) | - | 2019-09-28 | |
鹹顧鏇獵顧鑰廠鑰選遞(鹹鏇顧獵願襯蓋鏇夢醖) = 艱範糧製構鬱艱蓋膚糧 夢獵觸壓製製範遞糧廠 (齋獵夢鹹糧襯窪窪選蓋 ) | |||||||
临床3期 | 1,368 | beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide | 窪積築網醖餘願衊壓醖(獵襯願顧願蓋鑰鬱積窪) = 網願鏇窪壓網艱顧蓋鹹 淵襯衊鏇襯鬱膚構獵廠 (繭鏇夢衊襯鏇衊襯憲壓 ) 更多 | 优效 | 2016-09-03 | ||
beclometasone dipropionate and formoterol fumarate | 窪積築網醖餘願衊壓醖(獵襯願顧願蓋鑰鬱積窪) = 鑰範範繭醖窪選醖繭鑰 淵襯衊鏇襯鬱膚構獵廠 (繭鏇夢衊襯鏇衊襯憲壓 ) 更多 |
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