THE ANTES B+ STUDY: AN OPEN-LABEL, PRAGMATIC, RANDOMIZED, CONTROLLED TRIAL OF TRIPLE THERAPY VERSUS LABA-LAMA COMBINATION TO IMPROVE CLINICAL CONTROL IN HIGH-RISK GOLD B PATIENTS (B+) - ANTES B+

开始日期2024-02-29

申办/合作机构-

JPRN-UMIN000044134

/ SuspendedN/AIIT

The efficacy of high-dose ICS / LABA or medium-dose inhaled ICS / LABA / LAMA in patients with poor asthma control under medium-dose ICS / LABA administration - The efficacy of high-dose ICS / LABA or medium-dose inhaled ICS / LABA / LAMA in patients with poor asthma control under medium-dose ICS / LABA administration

开始日期2021-05-10

申办/合作机构

Showa University

JPRN-UMIN000034641

/ RecruitingN/AIIT

Safety of LAMA/LABA combination therapy in the COPD patients - Safety of LAMA/LABA combination therapy in the COPD patients

开始日期2018-10-22

申办/合作机构-

100 项与 LAMA 相关的临床结果

登录后查看更多信息

100 项与 LAMA 相关的转化医学

登录后查看更多信息

100 项与 LAMA 相关的专利（医药）

登录后查看更多信息

893

项与 LAMA 相关的文献（医药）

2025-12-31·Journal of Pharmaceutical Policy and Practice

Access to single-inhaler triple medicines for chronic obstructive pulmonary disease in China: a national survey on accessibility and utilisation

Article

作者: Wang, Menglei ; Yu, Shule ; Yang, Qingqing ; Guo, Wei ; Lu, Wei ; Zheng, Fangfang ; Wu, Huanhuan ; Chen, Hongdou ; Li, Wei

Background:

The maintenance medicines for chronic obstructive pulmonary disease (COPD) include inhaled corticosteroids (ICS), long-acting muscarinic antagonists (LAMA) and long-acting β2-agonists (LABA). Budesonide/glycopyrronium/formoterol (BUD/GLY/FOR) and fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) are two representative drugs for prefixed ICS/LAMA/LABA association in a single inhaler and have shown comparable efficacy and safety with other ICS/LAMA/LABA open combination therapies in patients with moderate-to-very severe COPD. This study aimed to investigate the availability, price, affordability, and utilisation of single-inhaler triple medicines for COPD in China.

Methods:

Quarterly data about the use of BUD/GLY/FOR and FF/UMEC/VI from 2020 to 2022 were collected from the Chinese Medicine Economic Information Network. We used the adjusted World Health Organization and Health Action International methodology to calculate the availability and affordability of the two investigated medicines in 596 tertiary general hospitals and 299 secondary general hospitals in 31 provincial administrative regions in China.

Results:

The availability and consumption of BUD/GLY/FOR were significantly higher than those of FF/UMEC/VI during the study period. At the end of 2022, the availability of BUD/GLY/FOR and FF/UMEC/VI in tertiary general hospitals was 69.80% and 52.01% respectively, while in secondary general hospitals, it was 52.51% and 28.76% respectively. Both medications were equally affordable at 1.3 days of the minimum wage after reimbursement in 2022. In the first quarter of 2021, with the inclusion of both drugs in the Medicare catalog, their DDDc decreased significantly, which was accompanied by notable improvements in their availability, affordability and consumption.

Conclusions:

The overall accessibility and consumption of BUD/GLY/FOR and FF/UMEC/VI were improved in China from 2020 to 2022. The implementation of the national drug price negotiation policy reduces the cost of drugs in China and plays an important role in improving the availability of the investigated drugs.

2025-12-31·Libyan Journal of Medicine

Determinants of poor chronic obstructive pulmonary disease control

Article

作者: Abu Heshmeh, Shrouq ; Al Hamarneh, Yazid N ; Abuzetun, Nid’a T. ; Jarab, Anan S. ; Alzoubi, Karem H. ; Momany, Suleiman M. ; Al-Qerem, Walid ; Aburuz, Salah

Uncontrolled COPD has been associated with reduced health-related quality of life, activity impairment, and increased use of healthcare resources. However, limited research is available on the factors associated with poor disease control in COPD patients. This study aimed to explore the factors associated with poor disease control in patients with COPD. The current cross-sectional study was conducted on patients with COPD who attended outpatient respiratory clinics at two major hospitals in Jordan. Information about disease and medication-related characteristics was collected through patient interviews and medical files. Validated instruments, including the 4-item medication adherence scale and the hospital anxiety and depression scales, were used to assess medication adherence, anxiety, and depression among the study participants. COPD severity was assessed using the GOLD classification criteria. Ordinal regression analysis was conducted to explore the variables associated with poor COPD control. In total, 702 patients participated in the study, with a median (interquartile range) age of 68 years (58-77). According to the GOLD report, most of the participants were in the B group (low risk/high symptoms; 40.2%), followed by the D group (high risk/high symptoms; 28.2%). Older age, higher depression scores, and a higher number of prescribed medications were associated with poorer COPD control, while not receiving LAMA (long-acting muscarinic antagonists) was associated with better control. Future mental health care initiatives should address the prevalence of depression symptoms in COPD patients and manage them effectively to improve COPD control and prevent further complications, with special attention to older patients, those receiving multiple medications, and those using LAMA.

2025-12-01·Chronic Respiratory Disease

Ensifentrine in COPD patients taking long-acting bronchodilators: A pooled post-hoc analysis of the ENHANCE-1/2 studies

Article

作者: Rickard, Kathleen Ann ; Dransfield, Mark ; Anzueto, Antonio ; Marchetti, Nathaniel ; Dixon, Amy L ; Reyner, Daniel ; Rheault, Tara ; Kalhan, Ravi

Background:

The efficacy and safety of ensifentrine, a novel PDE3/PDE4 inhibitor, were previously evaluated in the ENHANCE-1 (NCT04535986) and ENHANCE-2 (NCT04542057) trials. Here, we present a pooled post-hoc subgroup analysis of patients according to background chronic obstructive pulmonary disease (COPD) maintenance medication regimens.

Objective:

This analysis aimed to explore the efficacy and safety of ensifentrine in patients receiving long-acting muscarinic antagonists (LAMA) or long-acting beta-agonists with inhaled corticosteroids (LABA + ICS).

Methods:

Eligible patients had moderate to severe COPD, were aged 40–80 years, and were symptomatic at randomization. Patients were randomized 5:3, receiving twice-daily ensifentrine 3 mg or placebo via standard jet nebulizer over 24 weeks.

Results:

The pooled post-hoc analysis included 485 LAMA patients and 272 LABA + ICS patients. Ensifentrine showed lung function improvement over placebo at week 12, including average FEV1 AUC0–12 h in the LAMA (placebo-corrected least squares mean change from baseline [LSMC], 92 mL; 95% CI, 54, 131; p < 0.001) and LABA + ICS subgroups (LSMC, 74 mL; 95% CI, 27, 121; p = 0.002). Ensifentrine reduced the rate and risk of exacerbations in both LAMA (48% and 50%, respectively) and LABA + ICS (51% and 56%, respectively) subgroups. Ensifentrine-treated patients reported improvement in symptoms and quality of life over 24 weeks. The safety profile of ensifentrine in each subgroup was similar to the profile in the pooled modified intention-to-treat population.

Conclusions:

Nebulized ensifentrine offers a novel non-steroidal anti-inflammatory and bronchodilator treatment added to existing LAMA or LABA + ICS treatment options in patients with moderate to severe, symptomatic COPD.

112

项与 LAMA 相关的新闻（医药）

2025-06-12

·药筛

这个吸入制剂进口获批，国产仿制可以行动了

今天的NMPA中，有几个品种值得关注。首先第一个是瑞维那新吸入溶液进口获批，最开心的不是进口，而是一大波虎视眈眈的仿制药企业。瑞维那新也就是雷芬那辛，是一种长效毒蕈碱拮抗剂（LAMA）的雾化剂。它具有高度的肺特异性，在每天只用一次的情况下，能够保持长久的支气管扩张，同时防止毒蕈碱拮抗剂的全身性副作用，例如口干、便秘和尿潴留等。瑞维那新吸入溶液最初由Theravance Biopharma开发，2018年11月，美国FDA批准，用于中度至极重度慢性阻塞性肺病（COPD）患者。2019年，晖致医药通过合作获得了产品在大中华区的独家开发和商业化权。但是，本品在国内没有等级相关的专利，这就意味着没有专利保护，仿制药企业就能快速跟进。此前正大清江、长风药业、云南龙海、武汉人福利康4个企业曾申请过临床，但没有开展临床试验。原研获批后，大家都可以按4类仿制，不需要做验证性临床，以前的临床批件就是废纸了。江苏康倍得的利斯的明透皮贴剂获批，国产第3家，用于治疗轻、中度阿尔茨海默病的症状。2020年，山东绿叶按进口获批，2023年北京泰德获批。但整体销售情况不理想。另外，药探探的盐酸阿莫罗芬搽剂获批，第2家过评，但后面申请企业较多。快速筛选药品，就用摩熵药筛小程序广东联盟集采群已建！群已满200人，请加客服小筛微信，进群获取第一手资讯数据。

医药出海

2025-06-12

·药圈头条

刚刚，72个药品上市申请获批！新药两款

扫码免费报名刚刚，NMPA发布2025年06月12日药品批准证明文件送达信息，本批次共有72个受理号获批，均为上市申请，其中：晖致医药申报的瑞维那新吸入溶液（曾用名：雷芬那辛吸入溶液）获批上市，适应症为：治疗慢性阻塞性肺病（COPD）。瑞维那新是一种长效毒蕈碱拮抗剂（LAMA）的雾化剂。它具有高度的肺特异性，在每天只用一次的情况下，能够保持长久的支气管扩张，同时防止毒蕈碱拮抗剂的全身性副作用，例如口干、便秘和尿潴留等。瑞维那新吸入溶液最初由Theravance Biopharma开发，晖致医药在2019年通过合作获得了该产品的雾化剂型在大中华区的独家开发和商业化权。默沙东的帕博利珠单抗注射液新适应症获批上市，具体适应症尚未披露，据推测可能为联合化疗治疗不可切除、晚期或复发性恶性胸膜间皮瘤。完整批件信息如下：

上市批准

2025-06-12

·医药观澜

今日，晖致医药慢阻肺新药在中国获批上市

今日（6月12日），中国国家药监局（NMPA）官网刚刚公示，晖致医药（Viatris）申报的瑞维那新吸入溶液（曾用名：雷芬那辛吸入溶液，revefenacin）的上市申请已获得批准。公开资料显示，这是一款治疗慢性阻塞性肺病（COPD）的每日一次、长效雾化支气管扩张剂，此前已经于2018年获得美国FDA批准上市（商品名：YUPELRI）。截图来源：NMPA官网COPD是一种发病率上升的慢性炎症性肺部疾病，可引起肺部气流阻塞，导致呼吸困难。治疗COPD的核心目标在于改善患者的呼吸功能，从而减轻由慢性缺氧所引起的各种症状。其中，吸入药物作为COPD治疗的关键手段，因其能够直接作用于肺部并显著降低全身不良反应，而在缓解症状、预防病情恶化等方面发挥着至关重要的作用。然而传统的吸入药物往往需要患者频繁使用，这不仅对患者的日常生活质量造成了影响，还增加了用药过程中的复杂性和出错风险，尤其是对于老年人这类慢阻肺的高发人群。瑞维那新是一种长效毒蕈碱拮抗剂（LAMA）的雾化剂。它具有高度的肺特异性，在每天只用一次的情况下，能够保持长久的支气管扩张，同时防止毒蕈碱拮抗剂的全身性副作用，例如口干、便秘和尿潴留等。瑞维那新吸入溶液最初由Theravance Biopharma开发，晖致医药在2019年通过合作获得了该产品的雾化剂型在大中华区的独家开发和商业化权。2018年11月，美国FDA批准瑞维那新吸入溶液用于治疗中度至极重度慢性阻塞性肺病（COPD）患者。这项批准是基于瑞维那新在两项关键性3期临床试验中的表现。试验结果表明，瑞维那新吸入溶液与安慰剂相比，为COPD的肺功能带来统计显著并且具有临床意义的改善，可以帮助中度和极重度COPD患者将恶化风险降低15-18%。该药物同时表现出良好的安全性。2023年11月，晖致医药和Theravance Bioharma宣布瑞维那新吸入溶液在中国治疗COPD的3期临床试验取得积极结果。该研究达到了其主要疗效终点，与安慰剂相比，FEV1（第一秒用力呼气量）有统计学显著增加。新闻稿表示，该项研究结果将支持瑞维那新在中国获批上市。具体而言，这项研究共有258例患者入组，其中257例纳入安全性和完整分析集。两组基线特征平衡良好，129例使用瑞维那新吸入溶液治疗，128组使用安慰剂治疗。研究人群为中度至极重度COPD患者，平均基线FEV1预测值约为50%。在整个研究过程中，大约三分之二的患者仍然使用长效β -2激动剂/吸入皮质类固醇。第12周末次给药后，主要疗效分析——FEV1谷值与基线相比的平均变化，治疗组与安慰剂组的差异为150.9（104.1，197.7）mL。今日这款瑞维那新吸入溶液在中国获批，意味着该产品即将惠及中国患者。参考资料：[1]2025年06月12日药品批准证明文件送达信息. From https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250612171445101.html[2]VIATRIS AND THERAVANCE BIOPHARMA ANNOUNCE POSITIVE TOP-LINE RESULTS FROM YUPELRI® (REVEFENACIN) PHASE III TRIAL IN CHINA FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). Retrieved Nov 13, 2023. From https://investor.theravance.com/news-releases/news-release-details/viatris-and-theravance-biopharma-announce-positive-top-line-0[3] Theravance Biopharma and Mylan Receive FDA Approval for YUPELRI™ (revefenacin) in Adults with Chronic Obstructive Pulmonary Disease. Retrieved November 9, 2018, from https://www.prnewswire.com/news-releases/theravance-biopharma-and-mylan-receive-fda-approval-for-yupelri-revefenacin-in-adults-with-chronic-obstructive-pulmonary-disease-300747672.html免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

上市批准临床3期临床结果临床成功

100 项与 LAMA 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
慢性阻塞性肺疾病	临床阶段不明	英国	University Of Dundee	2014-06-22

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ATS2024	N/A	-	-	Umeclidinium	壓窪簾壓蓋廠艱願鑰夢(網獵衊衊觸憲鬱鹽衊觸) = 艱夢遞願蓋積夢鬱繭鏇積網衊鹽艱簾窪糧膚鑰 (製鏇蓋淵築網觸顧窪選 )	-	2024-05-19
				Vilanterol	窪膚鏇廠鹹襯餘糧廠憲(憲衊觸觸艱夢繭鹽窪遞) = 鏇積積蓋鹹鹽衊鹹顧鹹顧夢鑰選鹽獵築膚選膚 (鏇壓壓鏇鏇獵構鏇觸獵 )