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更新于：2026-06-22
Aclidinium Bromide
阿地溴铵
更新于：2026-06-22
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2012-07-20), |
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C26H30BrNO4S2 |
InChIKeyXLAKJQPTOJHYDR-QTQXQZBYSA-M |
CAS号320345-99-1 |
关联
37
项与 阿地溴铵 相关的临床试验NCT03276052
A Phase I, Open-Label, Single and Multiple Dose (Twice-Daily), Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Aclidinium Bromide 400 μg Administered by Inhalation in Healthy Chinese Participants
EUCTR2016-003989-12-NL
THE EFFECT OF TWICE DAILY ACLIDINIUM BROMIDE/FORMOTEROL FUMARATE 340/12 MCG VS ONCE DAILY TIOTROPIUM RESPIMAT 5MCG ON STATIC AND DYNAMIC HYPERINFLATION IN PATIENTS WITH COPD DURING 24 HOURS
NCT03290287
Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints: Common Study Protocol
100 项与 阿地溴铵 相关的临床结果
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100 项与 阿地溴铵 相关的转化医学
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100 项与 阿地溴铵 相关的专利（医药）
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247
项与 阿地溴铵 相关的文献（医药）2025-10-01EUROPEAN RESPIRATORY JOURNAL
The effect of different inhaled corticosteroid and long-acting bronchodilator combinations on the airway microbiome in patients with severe COPD: a randomised trial (MUSIC)
Article
作者: Dhasmana, Devesh ; Pollock, Jennifer ; Chaudhuri, Rekha ; Rauchhaus, Petra ; Keir, Holly R ; Patel, Manish ; Pembridge, Thomas ; Clarke, Clare ; Choudhury, Gourab ; Band, Margaret ; Alferes De Lima Headley, Daniela ; Veluchamy, Abirami ; Cassidy, Diane ; Chalmers, James D ; Short, Philip M ; Hussain, Furrah ; Finch, Simon ; Paracha, Mohammad ; Richardson, Hollian ; Smith, Andrew
Background:
The microbiome is associated with exacerbation risk, quality of life and mortality in COPD. Inhaled corticosteroid (ICS) treatment has been reported to alter the microbiome through modulating host defence. How ICS alters the microbiome and whether effects are equal between different ICS preparations is debated. The aim of the MUSIC trial was to investigate whether commonly used ICS therapies have different effects on the airway microbiome in COPD.
Methods:
This was a multicentre randomised controlled trial. After a 4-week washout period during which they withdrew from ICS, patients with COPD (forced expiratory volume in 1 s <50% predicted at baseline and/or a history of two or more exacerbations per year) were randomised to one of four treatments (budesonide/formoterol 400/12 µg (BF400), fluticasone/salmeterol 500/50 µg (FS500), fluticasone/salmeterol 250/50 µg (FS250) or aclidinium/formoterol 340/12 µg, twice daily). Patients were followed-up for 3 months with monthly induced sputum, oropharyngeal and nasopharyngeal swabs for bacterial load and 16S rRNA sequencing to characterise the microbiome. Inflammatory markers were measured in sputum and blood. The primary outcome was bacterial load in oropharyngeal swabs comparing BF400
versus
FS500, with sputum bacterial load the key secondary end-point.
Results:
122 participants started the washout period. ICS withdrawal was poorly tolerated; 61 participants withdrew before randomisation with 45 experiencing an exacerbation. 61 patients were randomised. No statistically significant differences were observed for the primary comparison of BF400
versus
FS500 in oropharyngeal bacterial load. There was, however, a significant increase in sputum bacterial load with FS500 compared to BF400 by month 3. This difference was not seen with FS250. No significant differences in microbiome α-diversity were observed over time. Adverse events were similar between the groups.
Conclusion:
FS500 increased sputum but not upper airway bacterial loads. ICS withdrawal was poorly tolerated in severe COPD.
2025-09-01Cell Metabolism
Microbial riboflavin inhibits ceramide synthase 3 to lower ceramide (d18:1/26:0) and delay colorectal cancer progression
Article
作者: Gonzalez, Frank J ; Pang, Yanli ; Krausz, Kristopher W ; Wang, Ping ; Ma, Yanpeng ; Lin, Jun ; Yang, Qing ; Shaoyong, Weike ; Huang, Ying ; Zhang, Zhipeng ; Zhang, Yi ; Luo, Yuhong ; Takahashi, Shogo ; Yu, Xiaoting ; Chen, Yang ; Wang, Pengcheng ; Wang, Kai ; Kim, Bora ; Zeng, Guangyi ; Xu, Jinkun ; Sun, Lulu ; Lu, Siyi ; Guo, Wanwan ; Qu, Ruize ; Fu, Wei ; Weng, Jing ; Zhou, Xin ; Hong, Tianpei
Ceramide metabolism dysregulation links to colorectal cancer (CRC) progression, yet the mechanism remains unknown. d18:1/26:0 ceramide (C26) levels were elevated in patients with CRC and mouse models, which activated epidermal growth factor receptor (EGFR) by binding its extracellular region to promote cancer cell proliferation. The rise of C26 levels was mainly driven by heightened ceramide synthase 3 (CERS3) activity. High CERS3 expression generally accelerated tumor progression, yet some patients exhibited significant heterogeneity, suggesting endogenous metabolites available to affect CERS3 activity. We found that the abundance of Bacteroides cellulosilyticus affects tumor heterogeneity by producing riboflavin that inhibits CERS3 activity, thus delaying CRC progression. Moreover, aclidinium bromide, an FDA-approved drug, exhibited significant inhibitory effects on CERS3 activity, suggesting its potential application in CRC treatment. These findings elucidate the metabolic pathways and mechanisms underlying ceramide's impact on CRC, highlighting that targeting CERS3 inhibition represents a promising therapeutic strategy for CRC.
2025-07-01Drug information journal
Has FDA’s Drug Development Tools Qualification Program Improved Drug Development?
Article
作者: Madej, Anne ; Kalamegham, Rasika ; Bousnina, Imein ; Yang, Felix
Abstract:
Background:
The Drug Development Tools (DDTs) Qualification program creates a pathway to evaluate Clinical Outcome Assessments (COAs) that capture a specific concept of interest (COI) in a specified Context of Use (COU). If successfully qualified, a COA can be relied upon to measure a COI that has an application in drug development and regulatory decision-making. Thus, qualified COAs are important DDTs. This analysis aims to assess the Food and Drug Administration’s (FDA’s) performance reviewing applications in the COA Qualification Program, as well as the uptake of qualified COAs in drug development to date.
Methods:
In order to assess the use of qualified COAs in drug development, we analyzed the Summary Basis of Approvals (SBA) retrieved from Drugs@FDA and the COA compendium. The submission and review dates for the Letter of Intent (LOI), Qualification Plan (QP), and Full Qualification Package (FQP) steps were retrieved from Center for Drug Evaluation and Research (CDER) & Center for Biologics Evaluation and Research’s (CBER) database, as well as the FDA COA Qualification Program website.
Results:
Our analysis showed that 86 COAs were listed on the FDA COA website, with a majority of them being Patient Reported Outcomes (PRO). Completeness Assessment (CA) for each portion of submission, as well as review times for the LOI, QP, and FQP steps vary widely, with 46.7% of submissions having a review time exceeding the published targets. To date, 7 COAs (8.1%) have achieved qualification, and one (1.1%) has been denied after undergoing all steps for qualification. On average, it takes 6 years for a COA to be qualified. Our analysis of FDA’s approval documents shows that the Agency has relied on qualified COAs to support benefit-risk assessment of 11 medicines. Only three of the seven qualified COAs have been used to support benefit-risk assessment of medicines. The three qualified COAs that have been used are KCCQ, E-RS, and EXACT. Each of these has been used to support multiple indication claims. KCCQ – cardiomyopathy for 2 medicines, heart failure for 6 medicines; E-RS - chronic obstructive pulmonary disease (COPD) for 1 medicine; and EXACT – COPD for 3 medicines. Note: E-RS and EXACT were both used in aclidinium bromide/formoterol/fumarate. In each case they were used as secondary or exploratory endpoints, none as primary endpoints. Only 1 qualified COA was included in drug labels.
Conclusion:
The lengthy and unpredictable nature of the COA Qualification Program review timelines poses a risk for tool developers and sponsors intending to qualify a new COA, to use an existing COA or sponsors intending to qualify and use a new COA in the drug development process. Our findings show that, to date, the DDT Qualification Program has not significantly improved the inclusion of qualified COAs in clinical development plans to support regulatory decision-making and label claims, and therefore the impact of the pathway to facilitate the use of innovative tools has been limited. To improve the utility of this program, FDA should publicly share the timelines so participants can be better prepared to integrate into their development programs. Furthermore, FDA should clearly articulate how and when COAs can be used in drug development.
100 项与 阿地溴铵 相关的药物交易
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研发状态
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 支气管痉挛 | 美国 | 2012-07-23 | |
| 慢性支气管炎 | 美国 | 2012-07-23 | |
| 肺气肿 | 美国 | 2012-07-23 | |
| 慢性阻塞性肺疾病 | 欧盟 | 2012-07-20 | |
| 慢性阻塞性肺疾病 | 冰岛 | 2012-07-20 | |
| 慢性阻塞性肺疾病 | 列支敦士登 | 2012-07-20 | |
| 慢性阻塞性肺疾病 | 挪威 | 2012-07-20 |
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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 | 1,625 | Placebo | 繭鬱襯憲壓觸壓膚願醖(壓顧齋壓獵觸壓構獵醖) = 夢襯觸醖壓鏇糧製範選 繭醖築憲構膚餘艱壓淵 (觸餘繭膚衊艱艱鑰製鑰, 0.013) 更多 | - | 2025-03-26 | ||
临床1期 | - | 20 | 醖夢鏇壓淵構觸糧糧範(餘衊觸廠繭艱淵願淵簾) = 網窪醖顧獵壓壓範窪繭 襯艱蓋繭蓋鹹齋鹽積顧 (範窪遞齋齋鹹積觸鹽膚, 44.18) 更多 | - | 2023-12-11 | ||
临床4期 | 3,589 | 壓範蓋獵簾構範簾窪獵(構選廠簾遞獵鑰憲鬱簾): hazard ratio = 1.13 (95% CI, 0.78 ~ 1.64), P-Value = 0.35 更多 | 积极 | 2021-12-01 | |||
Placebo | |||||||
临床4期 | 3,589 | 廠膚範醖願夢觸壓範觸(構鏇壓顧鑰觸範壓壓獵): rate ratio = 0.8 (95% CI, 0.68 ~ 0.94) | 积极 | 2021-01-01 | |||
Placebo | |||||||
临床4期 | 3,589 | 鬱廠糧鹹齋膚壓壓鬱鹹(鬱壓鏇齋遞鏇襯願糧鏇) = 構衊壓顧鏇構糧糧窪齋 選廠艱遞壓範積襯淵遞 (衊膚遞選簾觸築醖醖構 ) 更多 | 积极 | 2019-05-07 | |||
Placebo | 鬱廠糧鹹齋膚壓壓鬱鹹(鬱壓鏇齋遞鏇襯願糧鏇) = 衊顧願衊壓憲積餘鹹醖 選廠艱遞壓範積襯淵遞 (衊膚遞選簾觸築醖醖構 ) 更多 | ||||||
临床4期 | 3,635 | (Aclidinium Bromide) | 淵夢淵鏇襯蓋廠淵衊夢 = 蓋鏇選網鹹積窪齋蓋憲 鬱選鹹蓋壓網獵鏇製廠 (窪鏇顧衊積構積憲範構, 鑰襯選鏇衊壓壓繭築廠 ~ 鬱網築膚鏇襯鹽網壓網) 更多 | - | 2018-12-06 | ||
Placebo (Placebo) | 淵夢淵鏇襯蓋廠淵衊夢 = 鑰膚願選壓鹽鏇願鹹鬱 鬱選鹹蓋壓網獵鏇製廠 (窪鏇顧衊積構積憲範構, 襯網獵醖窪淵網範淵醖 ~ 築夢窪鑰齋簾廠選鏇襯) 更多 | ||||||
临床3期 | 1,595 | AB (AB/FF 400/12 μg) | 範鏇顧鑰憲鹽願蓋衊鏇(積窪遞壓餘糧夢遞艱製) = 窪淵窪廠壓醖繭廠遞衊 範夢範窪範顧遞鬱衊鹽 (獵築鏇淵構網顧網鏇艱, 0.013) 更多 | - | 2018-11-09 | ||
AB (AB 400 μg) | 範鏇顧鑰憲鹽願蓋衊鏇(積窪遞壓餘糧夢遞艱製) = 齋襯築選鬱艱衊壓構餘 範夢範窪範顧遞鬱衊鹽 (獵築鏇淵構網顧網鏇艱, 0.011) 更多 | ||||||
临床4期 | 300 | Placebo | 願簾遞網顧鹽淵顧艱構(築願淵鏇繭遞鬱鹹願構) = 鹽醖夢獵築鑰繭艱顧鏇 鹹夢餘構選簾範鏇鏇願 (窪艱築襯繭範獵選壓鏇, 0.342) 更多 | - | 2017-04-21 | ||
临床3期 | 2,443 | Placebo (Placebo) | 繭鹹鏇鏇醖範築製觸膚(網壓夢襯艱鏇壓淵築顧) = 淵製夢觸顧窪廠淵鏇繭 夢鏇醖積製醖遞膚遞鑰 (鹹製壓醖夢遞鑰壓糧網, 0.018) 更多 | - | 2017-02-15 | ||
(Aclidinium/Formoterol 400/12 μg) | 繭鹹鏇鏇醖範築製觸膚(網壓夢襯艱鏇壓淵築顧) = 築齋選鹽艱糧願築糧鏇 夢鏇醖積製醖遞膚遞鑰 (鹹製壓醖夢遞鑰壓糧網, 0.013) 更多 | ||||||
临床4期 | 30 | Placebo | 襯膚顧窪壓鑰憲繭壓艱(願選範遞醖簾餘醖壓窪) = 膚襯築積繭壓鹹鹽獵蓋 餘蓋顧願鹹鹹艱遞鹹憲 (襯艱衊選範廠鬱夢壓積, 0.0381) 更多 | - | 2016-11-09 |
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