A Randomised, Double-blind, Multi-centre, Placebo-controlled, Crossover Study to Assess the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler on Cardiac and Lung Function in Participants With Chronic Obstructive Pulmonary Disease and Hyperinflation

The purpose of the study is to evaluate the effect of BGF MDI compared with placebo MDI on cardiac and lung function when administered in participants diagnosed with COPD and hyperinflation.

开始日期2025-09-30

申办/合作机构

AstraZeneca PLC

[+1]

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2025-07-30

申办/合作机构

AstraZeneca PLC

NCT06712563

/ RecruitingN/A

Pooled Analysis of Multi-country, Open-label Single-arm, Non-interventional, Multi-center, Cohort Studies of Real-world Outcomes in New Users of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting

The CHOROS pooled analysis is a retrospective secondary data use analysis of integrated individual participant data from a series of planned and on-going primary prospective, non-interventional, multi-center studies sponsored by AstraZeneca and conducted in the pulmonary/primary care practitioner setting in multiple countries and may include data from the following countries: United Kingdom, Germany, Italy, Greece, Japan, Canada and Romania.

开始日期2025-04-17

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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项与布地格福相关的文献（医药）

2025-09-01·Respiratory Investigation

Real-world effectiveness of budesonide/glycopyrronium/formoterol fumarate metered dose inhaler on symptoms and quality of life in patients with COPD: EBISU study

Article

作者: Kawayama, Tomotaka ; Nishida, Kenichiro ; Kato, Yuki ; Yoshida, Yuri ; Hirai, Takehiro ; Sugiura, Hisatoshi ; Makita, Naoyuki ; Muro, Shigeo ; Hozawa, Soichiro

BACKGROUND:

There are limited real-world data regarding triple therapy with inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β₂-agonist on symptoms and patient-reported outcomes (PROs) in patients with chronic obstructive pulmonary disease (COPD), without current/history of asthma. We investigated the effects of budesonide/glycopyrronium/formoterol fumarate (BGF) metered dose inhaler (MDI) triple therapy on health status and PROs in patients with COPD in daily clinical practice.

METHODS:

This was a 12-week, prospective, multicenter, observational study (NCT05219630). The primary endpoint was mean change from baseline in the COPD Assessment Test (CAT) over 12 weeks. Secondary and exploratory endpoints included mean change from baseline in the St George's Respiratory Questionnaire (SGRQ) over 12 weeks and CAT score subgroup analyses.

RESULTS:

In total, 102 patients were analyzed; mean age at baseline was 73.8 years, mean forced expiratory volume in 1 s was 57.7 %, CAT total score was 15.6, and SGRQ score was 33.3. The adjusted mean change from baseline over 12 weeks in CAT was -2.9 (standard error [SE] 0.5) (P < 0.001), and in SGRQ was -2.7 (SE 0.9) (P = 0.004). As early as Week 4, these scores were significantly improved from baseline. In subgroup analyses, CAT scores were improved, regardless of blood eosinophil counts at baseline and exacerbation history in the previous year.

CONCLUSIONS:

Triple therapy with a BGF MDI significantly improved CAT and SGRQ scores over 12 weeks. BGF MDI could be a suitable option for patients living with COPD who have persistent symptoms without current asthma or a history of asthma.

TRIAL REGISTRATION:

ClinicalTrials.gov (NCT05219630).

2025-07-19·BMC Pulmonary Medicine

Effect of triple therapy on mortality and cardiovascular risk in patients with moderate to severe COPD: a meta-analysis of randomized controlled trials.

Review

作者: Li, Yubing ; Li, Jun ; Zhang, Yong ; Yang, Hongxia

BACKGROUND:

Chronic obstructive pulmonary disease (COPD), the third leading cause of global mortality, remains a significant challenge in long-term management. While dual bronchodilators (LAMA/LABA) and inhaled corticosteroid combination therapies (ICS/LABA) alleviate symptoms, patients continue to face elevated risks of all-cause mortality and cardiovascular events. Recent studies suggest that triple therapy (ICS/LAMA/LABA) may improve outcomes by reducing acute exacerbations and systemic inflammation. However, its long-term effects on mortality and cardiovascular safety remain controversial, highlighting the critical need for systematic evidence to inform clinical decision-making.

METHODS:

A systematic search of PubMed, Embase, and the Cochrane Library (up to July 2024) identified 13 randomized controlled trials (RCTs) comparing triple therapy with dual therapies (LAMA/LABA or ICS/LABA) in patients with moderate-to-severe COPD. Outcomes included all-cause mortality, exacerbation rates, and cardiovascular adverse events of special interest (CVAESI). Risk ratios (RR) with 95% confidence intervals (CI) were calculated using fixed- or random-effects models based on heterogeneity (assessed via I² statistics). Subgroup analyses explored heterogeneity across drug combinations, supplemented by sensitivity analyses and publication bias assessments.

RESULTS:

Compared to LAMA/LABA dual therapy, triple therapy significantly reduced all-cause mortality (RR = 0.76, 95% CI = 0.60-0.97, p = 0.03), moderate-to-severe exacerbation risk (RR = 0.93, 95% CI = 0.90-0.97, p = 0.0003), and overall CVAESI incidence (RR = 0.75, 95% CI = 0.61-0.93, p = 0.008), with a 38% reduction in severe CVAESI (hospitalized or fatal events: RR = 0.62, 95% CI = 0.45-0.86, p = 0.004). Subgroup analyses demonstrated that the BGF regimen achieved superior reductions in CVAESI (RR = 0.72, 95% CI = 0.58-0.89, p = 0.003) and severe CVAESI (RR = 0.61, 95% CI = 0.47-0.79, p = 0.0002) compared to other triple therapies. Although BGF showed only a nonsignificant trend toward mortality reduction (RR = 0.77, 95% CI = 0.58-1.03, p = 0.08), it exhibited greater efficacy in reducing exacerbations (RR = 0.72 vs. non-BGF regimens) and cardiovascular risks. Non-BGF triple therapies yielded inconclusive results due to limited sample sizes and substantial heterogeneity (I²=62-83%, subgroup difference p < 0.05). Sensitivity analyses confirmed the stability of pooled estimates (< 5% variation upon study exclusion), with no significant publication bias detected via funnel plots or Begg's test (p > 0.05).

CONCLUSION:

This study confirms that ICS/LAMA/LABA triple therapy significantly reduces mortality, exacerbations, and cardiovascular risks in moderate-to-severe COPD compared to LAMA/LABA dual therapy. The BGF regimen, with optimized drug delivery and synergistic anti-inflammatory/bronchodilatory effects, shows superior clinical benefits, especially in high-risk patients. However, triple therapy did not improve survival or cardiovascular outcomes versus ICS/LABA. Differences in ICS pharmacokinetics highlight the need for personalized strategies based on eosinophil levels and adherence. BGF may be considered a preferred option for patients at high risk of exacerbations or with cardiovascular comorbidities. Future studies should compare triple therapies head-to-head and standardize cardiovascular endpoints to clarify long-term outcomes.

2025-04-01·AMERICAN JOURNAL OF MEDICINE

Effectiveness of Single Versus Multiple Inhaler Triple Therapy on Mortality and Cardiopulmonary Risk Reduction in COPD: The SKOPOS-MAZI Study

Article

作者: Müllerová, Hana ; Vogelmeier, Claus F. ; Hawkins, Nathaniel M ; Rhodes, Kirsty ; Vogelmeier, Claus F ; Marshall, Jonathan ; Pollack, Michael ; Anzueto, Antonio ; Hawkins, Nathaniel M. ; Rapsomaniki, Eleni

BACKGROUND:

Patients with chronic obstructive pulmonary disease (COPD) have elevated cardiopulmonary and mortality risk, particularly following exacerbations. While single inhaler triple therapies (SITTs), such as budesonide/glycopyrrolate/formoterol fumarate (BGF), reduce cardiopulmonary risk versus dual bronchodilator therapy, there is limited evidence comparing outcomes with SITTs versus multiple inhaler triple therapies (MITTs).

METHODS:

SKOPOS-MAZI was a retrospective comparative effectiveness study in patients with COPD aged ≥40 years using US administrative claims data from Optum's deidentified Clinformatics® Data Mart Database. The primary and secondary endpoints were time to all-cause mortality and time to first severe cardiopulmonary event following initiation of BGF or MITT (identification period: October 1, 2020-June 30, 2023; index date: first prescription fill). Relative hazards of outcomes were assessed until a censoring event using Cox proportional hazards models, with inverse propensity treatment weighting accounting for between-group imbalances (standardized mean difference >0.1) in baseline characteristics.

RESULTS:

In the primary cohort, risk (hazard ratio [95% confidence intervals]) of all-cause mortality and a first severe cardiopulmonary event were 18% (0.82 [0.75, 0.91]) and 12% (0.88 [0.83, 0.93]) lower in patients initiating BGF versus MITT; results were consistent across censoring definitions, landmark periods, and sensitivity cohorts.

CONCLUSION:

In this real-world comparative effectiveness study of patients with COPD initiating BGF or MITT, BGF was associated with lower all-cause mortality and severe cardiopulmonary event risk versus MITT after accounting for between-group differences in baseline sociodemographic and clinical characteristics. This study supports the benefits of BGF over MITT and the need to consider proactive use of SITTs in COPD management.

110

项与布地格福相关的新闻（医药）

2025-07-25

·astrazeneca.com

Trixeo Aerosphere receives positive EU CHMP opinion as first inhaled medicine using next-generation propellant with near-zero Global Warming Potential

AstraZeneca’s Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF), already licensed for the treatment of chronic obstructive pulmonary disease (COPD) in adults, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, endorsing it for use in the European Union (EU) with an innovative, next-generation propellant with near-zero Global Warming Potential (GWP).1 Trixeo is the first medicine delivered by a pressurised metered-dose inhaler (pMDI) using a propellant that offers 99.9% lower GWP than propellants used in currently available pMDIs.2 This fixed-dose triple-combination therapy, marketed as Breztri Aerosphere in the US, China and Japan, will now have a low carbon footprint comparable to inhaled medicines that do not require a propellant.3 Based on the CHMP positive opinion, AstraZeneca will now begin to transition its Trixeo supply to the next-generation propellant in Europe. The CHMP positive opinion is based on results from the next-generation propellant clinical development programme, which demonstrated bioequivalence between Trixeo with the next-generation propellant and Trixeo with the current propellant.4,5 The safety and tolerability profile for Trixeo with the next-generation propellant was consistent with the known profile of the medicine. Frederik Trinkmann, Professor and Senior Pulmonologist at the Thoracic Clinic at Heidelberg University Hospital, Germany, said: “Respiratory medicines delivered by pressurised metered-dose inhalers are essential for millions of people living with respiratory diseases in Europe, including specific vulnerable populations such as children and the elderly. The transition of Trixeo to the propellant with near-zero Global Warming Potential ensures clinicians’ treatment decisions can focus on clinical needs while also supporting environmental goals.” Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “The CHMP positive opinion of Trixeo Aerosphere with the next-generation propellant allows us to address the needs of both patients and the planet and is a significant milestone in our commitment to delivering innovations for sustainable healthcare in the EU. Starting with Trixeo, the transition to the near-zero Global Warming Potential propellant across our pressurised metered-dose inhaled respiratory medicines is an important step towards achieving our Ambition Zero Carbon strategy.” Susanna Palkonen, Director of the European Federation of Allergy and Airways Diseases Patients' Associations, said: “COPD is a devastating disease and the third leading cause of mortality in the world. People living with COPD need access to a treatment which is right for them as well as a healthy environment and clean air. We welcome the positive opinion from the CHMP for the inhaled respiratory medicine containing the next-generation propellant with a significantly reduced carbon footprint.” Trixeo with the next-generation propellant received its first approval in the UK in May 2025 with regulatory applications also currently under review in China and additional countries. Trixeo is the first medicine in AstraZeneca’s portfolio of medicines delivered by pMDIs to transition to the new propellant. AstraZeneca aims to transition its wider pMDI portfolio to the near-zero GWP propellant by 2030 as part of the Company’s Ambition Zero Carbon strategy. In the EU, the Company plans to initiate the transition of Trixeo to the next-generation propellant in the coming months. Chronic respiratory diseases, including COPD, affect hundreds of millions of people around the world.6 Respiratory inhaled medicines delivered by pMDIs account for 76% of all inhaler use in Europe, and contribute 0.04% of global greenhouse gases.7,8 Studies show that the largest environmental contribution from respiratory diseases comes from patients’ symptoms not being adequately controlled and resulting increased healthcare utilisation.9,10 Implementing evidence-based guidelines into clinical practice can reduce exacerbations and unscheduled healthcare utilisation, and the resulting improved patient outcomes may also decrease the overall carbon footprint associated with respiratory care.11 Notes AstraZeneca’s next-generation propellant clinical development programme The clinical development programme has been initiated to assess the efficacy and safety of the next-generation, near-zero Global Warming Potential propellant with the AstraZeneca portfolio of inhaled medicines delivered by pressurised metered-dose inhalers (pMDIs). The first medicine to be assessed in the programme was Breztri/Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF) through in vitro, in vivo bioequivalence (PK), safety and efficacy clinical studies.12-17 The programme established bioequivalence between Breztri/Trixeo with the next-generation propellant and Breztri/Trixeo with the current propellant.4,5 The safety and tolerability profile for Breztri/Trixeo with the next-generation propellant was consistent with the known profile of the medicine. Additional studies are underway to assess the bioequivalence of the next-generation propellant to the current propellant with AstraZeneca’s other medicines delivered by pMDIs. Breztri/Trixeo Aerosphere Budesonide/glycopyrronium/formoterol fumarate (BGF), approved under the brand name Trixeo Aerosphere in the EU and UK and Breztri Aerosphere in Japan, China and the US, is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a long-acting β2 agonist (LABA), glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA), with budesonide, an inhaled corticosteroid (ICS), and delivered via the Aerosphere pMDI. Breztri/Trixeo Aerosphere is approved to treat COPD in more than 80 countries worldwide including the US, EU, China, Japan, and has been prescribed to more than five million patients globally. Breztri/Trixeo Aerosphere with the next-generation propellant will maintain the same indication, product strength and dosage regimen as Breztri/Trixeo Aerosphere with the current propellant. AstraZeneca’s Collaboration with Honeywell Developed by Honeywell, the medical grade version of the next-generation propellant is critical to enable the transition of pMDI medicines with reduced climate impact, given its near-zero GWP. AstraZeneca announced in 2022 its collaboration with Honeywell to develop respiratory inhaled medicines using the new propellant. Ambition Zero Carbon Through its Ambition Zero Carbon strategy, AstraZeneca is pursuing bold, science-based decarbonisation targets, accelerating progress towards net zero. AstraZeneca was one of the first seven companies globally to have its net zero targets verified by the Science-Based Targets initiative (SBTi) Corporate Net-Zero Standard. AstraZeneca in Respiratory & Immunology Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company. AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Corporate and financial

上市批准

2025-07-11

·同写意

FDA百日新政：公开逾200份拒批函，启动系统性监管改革

同写意年度巨献！！7月25-26日，邀您相聚金鸡湖畔，与5000人一起为中国医药创新“同写意”！7月10日，FDA首次集中公开超200份药品完整回复函（CRL），覆盖礼来、再生元等大小药企2020-2024年间未获批准的申请（部分追溯至2009年）。对此，FDA局长Marty Makary表示，过去药企如同在审批迷宫中猜谜，资本与创新都需要可预测性。“今天我们推动的透明革命，终将让有效疗法更快抵达患者。”在公开CRL的同天，这位局长同步交出了履职百日的改革清单，医药部分主要涉及加速批准的相关举措。这场改革正值FDA深陷信任危机。特朗普政府上任半年来，超半数高层离职，大规模裁员未作说明、专家会议无预警延期等事件持续发酵。行动速度令人震惊却缺乏解释，行业普遍焦虑。TONACEA01拒批函背后尽管此次公开打破历史惯例，但绝大多数文件曾作为药品获批材料附件披露。真正的新信息聚焦于两例：阿斯利康2019年慢性阻塞性肺病药Breztri，因关键试验未达主要终点被拒；安斯泰来2024年眼药Izervay标签更新申请，因延长给药间隔方案缺乏数据支持被否。耐人寻味的是，阿斯利康当年公告仅称“收到FDA反馈”，却隐去“未能证明药物安全性”的核心问题；安斯泰来将拒批原因简化为“统计问题”，回避FDA指出的“方案无数据支撑”事实。这种选择性披露似乎成为行业惯例。FDA援引2015年研究称，85%企业公告避谈安全性质疑，40%隐瞒后续临床试验要求。公告指出，教训未能共享会导致错误重演。值得一提的是，本次公开的所有拒批药物最终均获上市，包括再生元明星药Eylea（2023年被拒）、第一三共降胆固醇药Welchol咀嚼片（2017年被拒）等。当被问及公开CRL前是否告知企业时，FDA仅表示“文件已脱敏商业秘密”，未正面回应咨询流程。披露的CRL可至FDA官网下载查询：https://open.fda.gov/apis/other/approved_CRLs/TONACEA02百日改革在公开拒批函的同时，Makary同步交出了履职百日的改革清单。在医药部分，公告主要列出了加速批准的相关举措。减少动物实验：发布路线图，推进“器官芯片”、计算机模拟等人体相关技术替代动物实验。宣布拟启动试点计划：在FDA密切指导下，特定单克隆抗体开发商可采用以非动物实验为主的测试策略。局长国家优先审评凭证计划：宣布试点计划，针对涉及美国国家优先事项的最终申请（如应对重大健康危机、未满足的公共卫生需求、提升本土药物生产、为美国民众提供创新疗法），将药物审评流程从10-12个月压缩至1-2个月。解除特定基因疗法限制：取消已获批BCMA与CD19靶向自体CAR-T细胞免疫疗法的风险评估与减灾策略（REMS）要求，这是向该领域常识性监管迈出的第一步。细胞与基因治疗创新：组织数十位行业专家圆桌会议，制定确保美国引领该领域创新前沿的行动方案。切断利益输送：在法律允许范围内，限制FDA监管企业（如制药公司）雇员担任FDA咨询委员会成员的情形，以减少潜在利益冲突，增强审评流程公正性。修订新冠疫苗监管框架：放弃“一刀切”策略，采用医生家长认可的风险分层审批机制。CEO倾听行动：启动六城巡回座谈，直面生物医药企业诉求。阿尔茨海默诊断突破：批准首款辅助诊断的血液检测设备，同步解绑实验室自建检测（LDT）管制。儿童用药警示升级：修订ADHD缓释刺激剂标签，明示六岁以下儿童使用可能导致体重减轻等风险。参考文章：1、FDA公告2、FDA Publishes Cache of Complete Response Letters in Bid for ‘Radical Transparency’；biospace3、Updated: FDA publishes repository of 200+ drug rejection letters, promising more in the future；endpoints

加速审批基因疗法免疫疗法细胞疗法优先审批

2025-07-10

·EndPoints

Updated: FDA publishes repository of 200+ drug rejection letters, promising more in the future

In a historic first, the FDA on Thursday released about 200 novel and generic drug rejection letters, bucking the agency’s former reticence to publicize the documents in one place. But it’s a small step as nearly all the letters reviewed by Endpoints News were previously disclosed as part of the drugs’ approval packages. Two of the complete response letters not previously disclosed included one for AstraZeneca’s COPD treatment Breztri Aerosphere in 2019 and one for a label update for Astellas’ eye drug Izervay in 2024. All of the rejection letters released are for drugs that have since been approved. AstraZeneca disclosed its CRL in a press release but did not mention that the FDA said the submitted data “do not provide substantial evidence of the efficacy and safety for the use of Breztri Aerosphere.” The CRL also said “the single Aerosphere phase 3 pivotal trial failed on the co-primary endpoint of change from baseline in trough FEV1 for the comparison of Breztri Aerosphere and the glycopyrrolate and formoterol fumarate combination.” AstraZeneca said in a statement to Endpoints that its 2019 press release on the Breztri complete response letter “is an accurate reflection of the status of the regulatory filing and data at the time.” Breztri was later approved in 2020 following submission of additional data. For Izervay’s label expansion, Astellas also announced the CRL in a press release in 2024, but said the FDA comments outlined in the CRL “focus on a statistical matter” and “are unrelated to the safety and benefit/risk of the use of IZERVAY.” The FDA, however, said in the CRL that the company’s proposal to extend the dosing interval “was not supported by the submitted data and was not replicated in a second adequate and well controlled study.” Astellas did not immediately respond to a request for comment. The FDA noted that according to a 2015 analysis conducted by FDA researchers, drug companies “avoided mentioning 85% of the FDA’s concerns about safety and efficacy when announcing publicly that their application was not approved. Moreover, when FDA calls for a new clinical trial for safety or efficacy, that critical information is not disclosed approximately 40% of the time.” The FDA said the CRLs have been redacted for trade secrets and confidential commercial information. It’s unclear if the agency contacted the sponsors prior to releasing the new letters. The agency also said it is in the process of publishing additional CRLs from its archives. “For far too long, drug developers have been playing a guessing game when navigating the FDA,” FDA Commissioner Marty Makary said in a statement. “Drug developers and capital markets alike want predictability. So today we’re one step closer to delivering it to them, with an ultimate goal of bringing cures and meaningful treatments to patients faster.” Editor’s Note: This story was updated with comment from AstraZeneca. An earlier version was updated to reflect a review of the documents released today, finding that some were previously disclosed in approval packages.

临床3期上市批准

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

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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
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
中度慢性阻塞性肺疾病	临床3期	加拿大	Pearl Therapeutics, Inc.	2015-08-20
严重慢性阻塞性肺疾病	临床3期	美国	阿斯利康投资（中国）有限公司	2015-08-20

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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


NCT05477108 (CTgov)	临床1期	慢性阻塞性肺疾病	108	BGF (Treatment A)	遞齋鬱襯製蓋憲餘壓願(鬱鹽願簾顧範蓋蓋夢艱) = 艱簾網製獵鑰窪願糧製鏇膚餘襯範糧膚鏇築糧 (齋糧範醖餘醖獵鑰窪獵, 61.09) 更多	-	2025-05-28
				BGF (Treatment B (Replicate 1))	遞齋鬱襯製蓋憲餘壓願(鬱鹽願簾顧範蓋蓋夢艱) = 鹹淵蓋簾鬱淵繭淵壓蓋鏇膚餘襯範糧膚鏇築糧 (齋糧範醖餘醖獵鑰窪獵, 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)	簾夢願壓夢夢鹹蓋願糧(顧衊壓願糧膚遞壓網艱) = 觸鑰鹹蓋顧構艱艱鏇齋獵鹹築醖淵構衊選壓簾 (構鹽廠選顧觸艱鑰蓋鬱, 1.30 ~ 1.45)	积极	2025-05-16
				Delayed initiation of Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	簾夢願壓夢夢鹹蓋願糧(顧衊壓願糧膚遞壓網艱) = 窪製壓繭艱壓鏇網鬱製獵鹹築醖淵構衊選壓簾 (構鹽廠選顧觸艱鑰蓋鬱, 1.85 ~ 1.94)
NCT04609878 (KALOS, Company_Website) 人工标引	临床3期	哮喘	-	Breztri Aerosphere	窪遞夢齋襯鹹鹽積餘壓(簾構鹹衊夢窪窪積憲範) = met all primary endpoints 選願製憲鑰夢鏇簾廠構 (餘蓋顧艱鑰積窪鑰積壓 ) 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	艱糧築衊獵網願鏇窪夢(憲築憲選願鹹鏇鹽鹹積) = met all primary endpoints 遞觸醖繭築築製廠鏇鏇 (遞觸鏇鏇鏇憲襯餘簾齋 ) 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)	顧壓鹽鬱鏇糧鹽醖窪積(製艱遞鑰夢積願蓋窪憲) = 餘齋憲壓選窪鹽淵築鹽淵齋夢繭鹽鏇夢獵選蓋 (淵願蓋遞餘膚築顧鹽鹽, 46.71) 更多	-	2025-04-29
				BAB+BGF (Treatment B (Replicate 1))	顧壓鹽鬱鏇糧鹽醖窪積(製艱遞鑰夢積願蓋窪憲) = 糧選製積製艱獵願鏇選淵齋夢繭鹽鏇夢獵選蓋 (淵願蓋遞餘膚築顧鹽鹽, 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)	鑰淵獵範餘壓顧蓋繭築(衊壓獵醖願窪襯繭襯觸) = Three participants in the BGF MDI group reported palpitations, with no other complications noted 衊簾襯簾蓋構獵顧襯蓋 (壓願窪糧鬱膚餘壓糧齋 ) 更多	积极	2025-04-01
				Budesonide/glycopyrronium/formoterol fumarate co-suspension metered dose inhaler (Control group)
ATS2024	N/A	慢性阻塞性肺疾病	-	Budesonide/Glycopyrrolate/Formoterol (BGF)	糧壓範餘製範製壓膚鹽(窪構壓憲膚繭鏇願繭餘) = 襯壓簾顧齋齋築鬱餘衊願顧襯範網淵獵顧廠膚 (顧淵製獵蓋鹹網淵積襯 )	-	2024-05-19
				Multiple Inhaler Triple Therapy (MITT)	糧壓範餘製範製壓膚鹽(窪構壓憲膚繭鏇願繭餘) = 艱夢範艱壓積簾獵壓壓願顧襯範網淵獵顧廠膚 (顧淵製獵蓋鹹網淵積襯 )
ATS2023	N/A	慢性阻塞性肺疾病	-	Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	製鏇築淵構製積觸範鑰(製壓網構顧齋鬱廠遞觸): HR = 0.61 (95% CI, 0.38 ~ 0.95), P-Value = 0.030	-	2023-05-21
				Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)
ATS2023	N/A	慢性阻塞性肺疾病	-	Prompt BGF initiation (≤30 days)	窪蓋鬱鑰網蓋選衊蓋遞(鹽壓簾齋膚鬱鑰簾顧鏇) = 糧繭願構艱餘齋艱鏇餘選願廠鹹鬱顧顧鬱襯獵 (獵積積構鏇壓遞觸窪衊, 0.04 ~ 0.09) 更多	-	2023-05-21
				Delayed BGF initiation (31-180 days)	窪蓋鬱鑰網蓋選衊蓋遞(鹽壓簾齋膚鬱鑰簾顧鏇) = 醖鏇醖膚製鬱鏇網鑰觸選願廠鹹鬱顧顧鬱襯獵 (獵積積構鏇壓遞觸窪衊, 0.06 ~ 0.10) 更多
NCT02497001 (Pubmed \| Appl Health Econ Health Policy)	临床3期	严重慢性阻塞性肺疾病	1,902	Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	觸網構襯壓網窪觸網膚(鏇衊築壓顧構齋顧簾醖) = 淵窪艱蓋願夢餘選獵簾遞夢齋衊製齋選廠壓簾 (獵鑰範窪膚憲網製鬱醖 ) 更多	-	2022-09-01
				Long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA)	觸網構襯壓網窪觸網膚(鏇衊築壓顧構齋顧簾醖) = 鹽積鹽鬱壓襯獵遞觸襯遞夢齋衊製齋選廠壓簾 (獵鑰範窪膚憲網製鬱醖 ) 更多