布地格福(Budesonide/Formoterol fumarate/Glycopyrronium Bromide) - 药物靶点：GR x mAChRs x β2-adrenergic receptor_在研适应症：慢性支气管炎，慢性阻塞性肺疾病，肺气肿_专利_临床

概要

基本信息

药物类型

小分子化药

别名

BGF MDI、Breztri Aerosphere、Budesonide/formoterol fumarate/glycopyrronium

+ [18]

靶点

GR x mAChRs x β2-adrenergic receptor

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)

治疗领域

感染呼吸系统疾病免疫系统疾病

在研适应症

慢性支气管炎慢性阻塞性肺疾病肺气肿+ [4]

非在研适应症-

原研机构

AstraZeneca PLC

在研机构

AstraZeneca PLC

Pearl Therapeutics, Inc.AstraZeneca Dunkerque Production SCS

+ [4]

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

日本 (2019-06-18),

慢性支气管炎慢性阻塞性肺疾病肺气肿

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C25H34O6

InChIKeyVOVIALXJUBGFJZ-KWVAZRHASA-N

CAS号51333-22-3

查看全部结构式(3)

关联

57

项与布地格福相关的临床试验

CTRI/2025/12/099667

/ Not yet recruiting临床4期

A Phase IV study to evaluate safety and efficacy of Glycopyrronium/Formoterol/Budesonide (12.5mcg/6mcg/200mcg) triple therapy delivered through pressurized metered dose inhaler [pMDI] in patients with Chronic Obstructive Pulmonary Disease (COPD). - None

开始日期2026-01-22

申办/合作机构

Cipla Ltd.

CTRI/2025/12/098671

/ Not yet recruiting临床4期

A post-marketing phase IV, multicentre, prospective study to observe the safety and tolerability of Breztri aerosphereR containing a fixed dose combination of Budesonide 160 mcg/ Glycopyrronium 7.2 mcg/ Formoterol fumarate dihydrate 5 mcg in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)

开始日期2025-12-30

申办/合作机构

AstraZeneca Pharma India Ltd.

NCT06531798

/ Not yet recruiting临床4期

Post-marketing Phase IV, Multicenter, Prospective Study to Observe the Safety and Tolerability of Breztri aerosphereTM Containing a Fixed Dose Combination of Budesonide 160 mcg/ Glycopyrronium 7.2 mcg/ Formoterol Fumarate Dehydrate 5 mcg in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The purpose of this study is to observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD.

开始日期2025-12-30

申办/合作机构

AstraZeneca PLC

100 项与布地格福相关的临床结果

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100 项与布地格福相关的转化医学

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100 项与布地格福相关的专利（医药）

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81

项与布地格福相关的文献（医药）

2026-02-01·Lancet 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 (BFF_A) and the current suspension formulation (Symbicort, BFF_S).

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); BFF_A 320 μg, 10 μg; or BFF_S 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 (AUC_0-3) 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 BFF_A, and 1196 received BFF_S). 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 AUC_0-3 across all comparisons (all p<0·05). Least squares mean differences in change from baseline in morning pre-dose trough FEV₁ and in FEV₁ AUC_0-3 over 24 weeks for BGF 28·8 versus BFF_combined 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 BFF_combined (incidence rate ratio 0·86, 95% CI 0·76-0·97; p=0·012) and versus BFF_S (0·82, 0·71-0·94; p=0·0043). Exacerbation rate ratio for BGF 28·8 versus BFF_A 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 BFF_A, and 698 (58·4%) with BFF_S. 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.

2026-02-01·Therapeutic Advances in Respiratory Disease

Bioequivalence of budesonide/glycopyrrolate/formoterol fumarate with a next-generation propellant versus hydrofluoroalkane-134a in healthy adults: phase I, randomized, double-blind, single-dose, partial-replicate, three-way cross-over lung exposure and total systemic exposure studies

Article

作者: Heijer, Maria ; Gillen, Michael ; Silva, Carlos ; Bednarczyk, Artur ; Collison, Kathryn ; Aurivillius, Magnus ; Sychowicz, Klementyna ; Raphiou, Ibrahim ; Goldwater, Ronald ; Patel, Mehul ; Shah, Mihir ; Xu, John ; Petullo, David ; Reddy, Jitendar ; Jassal, Mandeep ; Han, David

Background::

Hydrofluoroolefin-1234ze (HFO-1234ze) is a next-generation propellant with 99.9% lower global warming potential (GWP) than hydrofluoroalkane-134a (HFA-134a).

Objectives::

We report systemic and lung exposure bioequivalence for budesonide/glycopyrrolate/formoterol fumarate (BGF) components with HFO-1234ze versus HFA-134a.

Design::

These phase I, randomized, double-blind, single-dose, 3-way cross-over trials in healthy adults included three phases (screening; three single-dose treatment periods with 3- to 7-day washouts; follow-up).

Methods::

Participants were randomized to four BGF inhalations (160/9/4.8 µg/actuation) with test (HFO-1234ze) or reference (HFA-134a) treatments in one of three sequences, with HFA-134a administered during two of the three treatment periods. For lung exposure, oral activated charcoal was administered before and after treatment. Bioequivalence was considered established if the 90% confidence interval (CI) for the geometric mean ratio (GMR) was within 80%–125% (or expanded limits, if appropriate) for maximum plasma concentration (Cmax), area under the plasma concentration–curve from time zero to the last quantifiable concentration (AUClast) and AUC from time zero to infinity (AUCinf; US approach only).

Results::

Bioequivalence criteria were met across BGF components. The 90% CI for the GMR was within 80%–125% (or expanded limits) for HFO-1234ze versus HFA-134a, for systemic (GMR: Cmax, 85.41–99.29; AUClast, 95.74–102.48; AUCinf, 90.72–102.58) and lung (GMR: Cmax, 93.39–104.24, AUClast, 97.02–107.76; AUCinf, 101.45–112.22) exposure. No serious adverse events were reported.

Conclusion::

Total systemic and lung exposure to all BGF components met bioequivalence criteria for HFO-1234ze versus HFA-134a, with no new or unexpected safety findings. The near-zero GWP HFO-1234ze propellant is a viable replacement for HFA-134a.

Trial registration::

NCT05569421 (clinicaltrials.gov/study/NCT05569421) and NCT05477108 (clinicaltrials.gov/study/NCT05477108).

2026-01-01·CLINICAL THERAPEUTICS

Exposure to Budesonide, Glycopyrronium, and Formoterol With a Next-Generation Propellant Does Not Exceed Exposure With Hydrofluoroalkane-134a Propellant When Administered Via Pressurized Metered-Dose Inhaler With a Spacer

Article

作者: Heijer, Maria ; Patel, Mehul ; Petullo, David ; Kokot, Marek ; Andersson, Magdalena ; Pandya, Hitesh ; Gillen, Michael ; Bednarczyk, Artur ; Tan, Yubo ; Jassal, Mandeep ; Reddy, Jitendar

PURPOSE:

Hydrofluoroalkane-134a (HFA-134a), the propellant in the marketed budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) formulation, has a global warming potential (GWP) that falls above environmental regulation thresholds and therefore will be phased out. With global efforts to minimize carbon emissions, the hydrofluoroolefin-1234ze (HFO-1234ze) propellant, with a >99% lower GWP than HFA-134a, is in development for pressurized metered-dose inhalers (pMDIs). Spacers support drug delivery in patients with poor pMDI inhalation technique, but it is unknown if BGF exposure with HFO-1234ze exceeds that observed with HFA-134a when using a spacer.

METHODS:

This Phase I study assessed systemic BGF component exposure with HFO-1234ze versus HFA-134a when using a spacer, and for HFO-1234ze with and without a spacer. Participants (N = 42) were randomized to BGF with HFA-134a with a spacer (reference), HFO-1234ze with a spacer (test), and HFO-1234ze without a spacer (descriptive treatment) over 3 treatment periods in 1 of 6 sequences. As spacer devices help to increase exposure, the upper limit of the 90% confidence interval (CI) of geometric mean ratios (GMRs) was of interest, and bioequivalence was not included as a study objective.

FINDINGS:

Analyses demonstrated the upper 90% CI of the GMRs for maximum observed plasma concentration (Cmax) and area under the plasma concentration curve from time zero to the time of the last quantifiable concentration (AUClast) were <125% for all BGF components for HFO-1234ze versus HFA-134a when using a spacer, indicating exposure with HFO-1234ze did not exceed exposure with HFA-134a. Additionally, Cmax was increased for all BGF components with HFO-1234ze when using versus not using a spacer, with the largest increases observed among participants with the lowest exposure when not using a spacer, likely due to poor inhalation technique. No new safety findings, and no deaths or serious adverse events, occurred during the study.

IMPLICATIONS:

These findings provide evidence that may help to support the future use of HFO-1234ze propellant in BGF pMDIs.

177

项与布地格福相关的新闻（医药）

2026-02-26

·药研苑

诺华瑞米布替尼用于慢性诱导性荨麻疹3期研究达到主要终点

药品营销避坑”试读：药品导入期管理视频课（试听）药品生命周期管理（案例）药品立项需要注意什么（案例） 2026年2月18日，诺华Novartis宣布瑞米布替尼在治疗慢性诱导性荨麻疹（CIndU）3期临床试验RemIND中达到治疗终点。至第12周，三种类型的慢性诱导性荨麻疹，症状性皮肤划痕症、寒冷性荨麻疹和胆碱能性荨麻疹的完全缓解率瑞米布替尼组显著高于安慰剂组。慢性荨麻疹分为慢性自发性荨麻疹（Chronic Spontaneous Urticaria，CSU）和慢性诱导性荨麻疹（Chronic Inducible Urticaria，CIndU）。慢性诱导性荨麻疹是一组由特定诱因（冷、热、运动、压力、阳光、振动、水等）诱发、以风团和/或血管性水肿为主要临床表现的荨麻疹。相比于慢性自发性荨麻疹，慢性诱导性荨麻疹具有明确的诱因。慢性诱导性荨麻疹最常见的类型为皮肤划痕征（也称人工荨麻疹），其次为冷接触性荨麻疹和胆碱能性荨麻疹（中华医学会皮肤性病学分会免疫学组., 2023）。目前慢性诱导性荨麻疹的治疗以第二代抗组胺药为主，尽管指南推荐可以通过增加剂量（2-4倍）来控制慢性诱发性荨麻疹，但至少有超过四分之一的患者，仍不能实现有效控制（Torsten Zuberbier., 2024）。瑞米布替尼（Remibrutinib）为口服共价布鲁顿酪氨酸激酶（BTK）抑制剂，能够阻断BTK通路介导释放组胺等炎症介质。瑞米布替尼片（瑞普多Rhapsido）已分别于2025年9月和11月，获得FDA和国家药品监督管理局批准，用于抗组胺药控制不充分的成人慢性自发性荨麻疹。目前，诺华已向美国食品药品监督管理局（FDA）提交瑞米布替尼用于治疗症状性皮肤划痕症补充新药申请（sNDA）。推荐指数：★★★ 推荐原因：基于RemIND研究的结果，瑞米布替尼有望实现扩大在慢性荨麻疹中的适应症，奠定其在慢性荨麻疹领域的市场地位。相关阅读： 3期研究，诺和诺德CagriSema下一代GLP-1减重不敌替尔泊肽 2期临床，联邦制药三靶点UBT251 24周平均减重达19.7% 三生国健IL-17A单抗安沐奇塔单抗获批成人斑块状银屑病天广实抗CD20奥妥珠单抗β获批治疗视神经脊髓炎谱系疾病阿斯利康布地格福治疗哮喘3期临床试验取得阳性结果金赛药业亮丙瑞林6个月制剂治疗晚期前列腺癌研究成果发表礼来替尔泊肽国内获批单药治疗成人2型糖尿病礼来匹妥布替尼获批慢性淋巴细胞白血病/小淋巴细胞淋巴瘤 2025年1-3季度口崩片市场哪个强？ 2025年1-3季度口溶膜制剂哪家强？免疫检查点抑制剂，谁将成为下一个王者？质子泵相关抑酸类药物市场即将回暖改剂型，口服液体制剂“金矿”还是“陷阱” 相关内容只作为药物研发的参信息。不构成任何与用药咨询有关的建议。如需发稿，您可通过在药研苑公众号下以发送信息的方式将官网或官方公众号的稿件链接和标题发送给我们。我们将择优确定是否发布。

2026-02-26

·药研苑

百利天恒双抗ADC iza-bren晚期乳腺癌3期研究中期达到终点

药品营销避坑”试读：药品导入期管理视频课（试听）药品生命周期管理（案例）药品立项需要注意什么（案例） 2026年2月24日，百利天恒宣布中期分析显示iza-bren（研发代号：BL-B01D1）在用于局部晚期或转移性三阴乳腺癌3期期临床试验中达到主要终点。该研究为随机、开放标签、多中心3期临床试验，用于比较BL-B01D1与研究者选择的化疗方案，对于既往经紫杉烷类治疗失败的不可手术切除的局部晚期或转移性三阴乳腺癌患者的疗效和安全性。这是该iza-bren达到主要终点的第三个3期临床试验。三阴性乳腺癌是指雌激素受体（Estrogen Receptor，ER）、孕激素受体（Progesterone Receptor，PR）和人表皮生长因子受体2（Human Epidermal Growth Factor Receptor 2，HER-2）表达均为阴性的一类乳腺癌。作为一种恶性程度高、预后较差的乳腺癌亚型，由于缺乏上述明确的治疗靶点，其治疗进展相对缓慢，目前仍以化疗为主。 iza-bren（Izalontamab brengitecan）为百利天恒开发的靶向EGFR和HER3的双抗抗体偶联药物（ADC）。有效载荷为拓扑异构酶Ⅰ抑制剂喜树碱（camptothecin）衍生物Ed-04（DAR为8）。2023年12月，百时美施贵宝宣布与百利天恒下属企业SystImmune达成合作协议获得iza-bren在中国大陆之外的开发和商业化权利（Bristol Myers Squibb., 2023）。推荐指数：★★★ 推荐原因：对于晚期三阴乳腺可以选择的靶向药物不多。在该领域 iza-bren进入的难度相对较小。作为首个有希望获批的EGFR/HER3双抗ADC药物，拥有较好的市场前景。相关阅读： 3期研究，诺和诺德CagriSema下一代GLP-1减重不敌替尔泊肽 2期临床，联邦制药三靶点UBT251 24周平均减重达19.7% 三生国健IL-17A单抗安沐奇塔单抗获批成人斑块状银屑病天广实抗CD20奥妥珠单抗β获批治疗视神经脊髓炎谱系疾病阿斯利康布地格福治疗哮喘3期临床试验取得阳性结果金赛药业亮丙瑞林6个月制剂治疗晚期前列腺癌研究成果发表礼来替尔泊肽国内获批单药治疗成人2型糖尿病礼来匹妥布替尼获批慢性淋巴细胞白血病/小淋巴细胞淋巴瘤 2025年1-3季度口崩片市场哪个强？ 2025年1-3季度口溶膜制剂哪家强？免疫检查点抑制剂，谁将成为下一个王者？质子泵相关抑酸类药物市场即将回暖改剂型，口服液体制剂“金矿”还是“陷阱” 相关内容只作为药物研发的参信息。不构成任何与用药咨询有关的建议。如需发稿，您可通过在药研苑公众号下以发送信息的方式将官网或官方公众号的稿件链接和标题发送给我们。我们将择优确定是否发布。

2026-02-26

·药研苑

恒瑞SHR-1918治疗纯合子家族性高胆固醇血症上市申请获受理

药品营销避坑”试读：药品导入期管理视频课（试听）药品生命周期管理（案例）药品立项需要注意什么（案例） 2026年2月25日，恒瑞医药宣布SHR-1918注射液治疗成人和12岁及以上的未成年人纯合子家族性高胆固醇血症（HoFH）患者的上市许可申请，获得国家药品监督管理局受理。本次申请基于SHR-1918-202和SHR-1918-301两项临床试验的研究结果。SHR-1918-202为多中心、单臂2期临床试验，共纳入26例接受稳定背景降脂治疗仍控制不佳的成人HoFH患者。入组患者在背景降脂治疗的基础上，接受SHR-1918 600mg皮下注射，每4周一次（Q4WO），持续12周，随后进入8周随访期。至第12周，LDL-C较基线平均降低59.09%（约6.60mmol/L），TG较基线平均降低48.91%，非HDL-C、ApoB、Lp(a)、TC及HDL-C分别较基线平均降低57.74%、45.28%、23.53%、55.68%及22.12%（所有p<0.001）。HoFH不同基因型，包括复合杂合子、纯合子以及双杂合子患者LDL-C较基线分别平均降低56.40%、61.32%及72.21%。15.4%的受试者实现LDL-C达标，84.6%的受试者LDL-C降低≥50%。在安全性方面，16例患者（61.5%）发生治疗期间不良事件，最常见的是蛋白尿4例（15.4%）。1例患者（3.8%）发生注射部位反应（包括疼痛和皮疹或红斑，均为1级）（Daoquan Peng., 2026）。 SHR-1918为全人源抗ANGPTL3（血管生成素样蛋白3）单克隆抗体。ANGPTL3主要由肝脏分泌，对脂蛋白脂肪酶（LPL）和内皮脂肪酶（EL）具有抑制作用。LPL和EL在清除甘油三脂中发挥重要作用，因此ANGPTL3抑制剂能够降低甘油三脂。EL在清除VLDL和HDL中发挥重要作用，VLDL是LDL的前体，因此ANGPTL3抑制剂能够降低LDL-C和HDL-C。纯合子家族性高胆固醇血症（HoFH）是严重危及生命的罕见遗传代谢性疾病，以血浆低密度脂蛋白胆固醇水平明显升高、皮肤和/或肌腱黄色瘤和早发动脉粥样硬化性心血管疾病快速进展为主要特征。HoFH患者LDLR（低密度脂蛋白受体）存在缺陷，导致LDLR清除LDL的能力有限，造成LDL-C异常积累。该类患者对于他汀类药物和PCSK9抑制剂的治疗反应相对较差，对于ANGPTL3抑制剂的影响相对较小。推荐指数：★★ 推荐原因：ANGPTL3抑制剂在治疗HoFH方面，具有积极的治疗意义，但该类患者相对较少；对于非HoFH高胆固醇血症的治疗意义低于PCSK9抑制剂，并且也会降低HDL-C。SHR-1918另一个潜在的用途是治疗甘油三脂血症，但距离批准尚需时日。相关阅读： 3期研究，诺和诺德CagriSema下一代GLP-1减重不敌替尔泊肽 2期临床，联邦制药三靶点UBT251 24周平均减重达19.7% 三生国健IL-17A单抗安沐奇塔单抗获批成人斑块状银屑病天广实抗CD20奥妥珠单抗β获批治疗视神经脊髓炎谱系疾病阿斯利康布地格福治疗哮喘3期临床试验取得阳性结果金赛药业亮丙瑞林6个月制剂治疗晚期前列腺癌研究成果发表礼来替尔泊肽国内获批单药治疗成人2型糖尿病礼来匹妥布替尼获批慢性淋巴细胞白血病/小淋巴细胞淋巴瘤 2025年1-3季度口崩片市场哪个强？ 2025年1-3季度口溶膜制剂哪家强？免疫检查点抑制剂，谁将成为下一个王者？质子泵相关抑酸类药物市场即将回暖改剂型，口服液体制剂“金矿”还是“陷阱” 相关内容只作为药物研发的参信息。不构成任何与用药咨询有关的建议。如需发稿，您可通过在药研苑公众号下以发送信息的方式将官网或官方公众号的稿件链接和标题发送给我们。我们将择优确定是否发布。

100 项与布地格福相关的药物交易

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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,

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适应症	国家/地区	公司	日期
慢性支气管炎	日本	AstraZeneca KK	2019-06-18
慢性阻塞性肺疾病	日本	AstraZeneca KK	2019-06-18
肺气肿	日本	AstraZeneca KK	2019-06-18

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
哮喘	申请上市	中国	AstraZeneca Dunkerque Production SCS	2025-09-17
哮喘	申请上市	中国	AstraZeneca AB	2025-09-17
中度慢性阻塞性肺疾病	临床3期	美国	阿斯利康投资（中国）有限公司	2015-08-20
中度慢性阻塞性肺疾病	临床3期	美国	AstraZeneca Dunkerque Production SCS	2015-08-20
中度慢性阻塞性肺疾病	临床3期	美国	Pearl Therapeutics, Inc.	2015-08-20
中度慢性阻塞性肺疾病	临床3期	日本	Pearl Therapeutics, Inc.	2015-08-20
中度慢性阻塞性肺疾病	临床3期	日本	AstraZeneca Dunkerque Production SCS	2015-08-20
中度慢性阻塞性肺疾病	临床3期	日本	阿斯利康投资（中国）有限公司	2015-08-20
中度慢性阻塞性肺疾病	临床3期	加拿大	阿斯利康投资（中国）有限公司	2015-08-20
中度慢性阻塞性肺疾病	临床3期	加拿大	AstraZeneca Dunkerque Production SCS	2015-08-20

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04609878 \| NCT04609904 (KALOS, Pubmed \| Lancet Respir Med)	临床3期	哮喘	8,820	Budesonide-glycopyrronium-formoterol fumarate dihydrate 320 µg, 28.8 µg, 10 µg	簾醖繭憲鑰壓夢廠範遞(積繭願鑰觸鏇製鏇鬱艱) = 網餘襯願齋窪鏇夢醖鬱襯選製憲窪選夢齋遞窪 (艱衊獵艱糧憲範願願憲 )	积极	2026-02-01
				Budesonide-glycopyrronium-formoterol fumarate dihydrate 320 µg, 14.4 µg, 10 µg	簾醖繭憲鑰壓夢廠範遞(積繭願鑰觸鏇製鏇鬱艱) = 膚築糧鹽夢構糧築顧繭襯選製憲窪選夢齋遞窪 (艱衊獵艱糧憲範願願憲 )
NCT05573464 (CTgov)	临床3期	慢性阻塞性肺疾病	559	BGF MDI HFA 320/14.4/9.6 μg	選選衊遞餘鬱網觸遞鹽 = 窪餘積衊顧淵鹽淵顧蓋艱願膚齋觸壓願憲壓網 (網願淵蓋衊鹽繭鬱範壓, 壓願膚蓋鑰壓蓋齋網鏇 ~ 糧獵衊衊膚顧製夢醖築) 更多	-	2025-09-19
NCT05477108 (CTgov)	临床1期	慢性阻塞性肺疾病	108	BGF (Treatment A)	獵願醖蓋構鹽構憲築艱(願鏇醖觸範艱醖觸廠構) = 構鹽鹹窪範夢襯獵製遞廠壓選餘遞願憲範網齋 (鑰觸範膚艱獵憲憲願觸, 61.09) 更多	-	2025-05-28
				BGF (Treatment B (Replicate 1))	獵願醖蓋構鹽構憲築艱(願鏇醖觸範艱醖觸廠構) = 願窪鑰繭構艱顧構選構廠壓選餘遞願憲範網齋 (鑰觸範膚艱獵憲憲願觸, 63.42) 更多
MITOS EROS+CP (US) Study (ATS2025)	N/A	哮喘-慢性阻塞性肺疾病重叠综合征	8,837	Prompt initiation of Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	願築膚繭鹹衊齋顧醖積(鹹網艱範遞構簾繭艱齋) = 鹹糧糧鹽齋糧獵範觸鹽選憲製獵廠鹽衊顧艱選 (醖淵鏇願築範鹹膚艱築, 1.30 ~ 1.45)	积极	2025-05-16
				Delayed initiation of Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	願築膚繭鹹衊齋顧醖積(鹹網艱範遞構簾繭艱齋) = 製窪製簾艱顧蓋衊膚獵選憲製獵廠鹽衊顧艱選 (醖淵鏇願築範鹹膚艱築, 1.85 ~ 1.94)
NCT04609878 (KALOS, Company_Website) 人工标引	临床3期	哮喘	-	Breztri Aerosphere	觸鑰膚襯願淵艱鏇鹹淵(積鑰窪窪繭廠蓋窪願構) = met all primary endpoints 糧衊膚願餘窪艱壓鹹製 (糧鏇餘遞積觸醖繭膚鬱 ) 达到	积极	2025-05-02
				Budesonide and formoterol fumarate
NCT04609904 (LOGOS, Company_Website) 人工标引	临床3期	哮喘	-	Breztri Aerosphere	鑰鑰廠膚鹹顧鹽願範壓(獵製醖顧觸襯構襯醖衊) = met all primary endpoints 壓築衊窪窪網鹽醖壓廠 (遞獵窪齋壓簾壓糧壓襯 ) 达到	积极	2025-05-02
				Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg
NCT05569421 (CTgov)	临床1期	慢性阻塞性肺疾病	108	BAB+BGF (Treatment A)	鹹糧選膚選構衊糧艱衊(醖範觸繭積壓醖網蓋製) = 鹽廠鑰網願鬱積窪廠鑰鏇餘遞鹹鏇鹽遞鹽簾製 (簾蓋網網鬱遞淵繭構窪, 46.71) 更多	-	2025-04-29
				BAB+BGF (Treatment B (Replicate 1))	鹹糧選膚選構衊糧艱衊(醖範觸繭積壓醖網蓋製) = 遞積糧齋憲鹽鏇築壓鏇鏇餘遞鹹鏇鹽遞鹽簾製 (簾蓋網網鬱遞淵繭構窪, 40.78) 更多
NCT05472350 (Pubmed \| Transl Lung Cancer Res)	N/A	咳嗽	-	Budesonide/glycopyrronium/formoterol fumarate co-suspension metered dose inhaler (BGF MDI)	觸觸窪製網築積願餘鏇(糧襯築夢餘憲範鏇壓艱) = Three participants in the BGF MDI group reported palpitations, with no other complications noted 積蓋齋壓願鬱蓋襯衊餘 (繭夢壓鑰壓鏇繭鑰廠糧 ) 更多	积极	2025-04-01
				Budesonide/glycopyrronium/formoterol fumarate co-suspension metered dose inhaler (Control group)
AURA Germany (ERS2024)	N/A	慢性阻塞性肺疾病	1,148	Budesonide/Glycopyrrolate/Formoterol (BGF)	鏇憲願窪獵衊築願築選(鬱鬱淵憲願窪餘壓選選) = 衊積膚構鬱積齋築製鏇鏇齋簾齋顧艱範鬱鹽簾 (鏇繭艱繭顧繭齋膚糧選 ) 更多	积极	2024-09-07
AURA UK (ERS2024)	N/A	慢性阻塞性肺疾病	2,342	Budesonide/Glycopyrrolate/Formoterol (BGF)	窪範鏇襯選夢網餘壓簾(齋壓齋鏇鑰構憲願膚艱) = 積夢繭網鑰餘繭壓夢簾壓鏇艱淵積製餘選醖醖 (夢糧範選製淵窪積鬱獵 )	积极	2024-09-07