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更新于：2026-02-27
Aclidinium Bromide
阿地溴铵
更新于：2026-02-27
概要
基本信息
原研机构 |
非在研机构 |
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
35
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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234
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 ; Veluchamy, Abirami ; Alferes De Lima Headley, Daniela ; Cassidy, Diane ; Chalmers, James D ; Short, Philip M ; Finch, Simon ; Hussain, Furrah ; 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 ; Yu, Xiaoting ; Takahashi, Shogo ; Chen, Yang ; Wang, Pengcheng ; Wang, Kai ; Kim, Bora ; Zeng, Guangyi ; Xu, Jinkun ; Sun, Lulu ; Lu, Siyi ; Qu, Ruize ; Guo, Wanwan ; 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
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 |
|---|---|---|---|
| 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 |
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 |
|---|---|---|---|---|
| 纵隔疾病 | 临床3期 | 意大利 | 2011-09-28 | |
| 慢性肺疾病 | 临床3期 | 德国 | 2011-08-01 | |
| 咳嗽 | 临床3期 | 德国 | 2011-08-01 | |
| 呼吸困难 | 临床3期 | 德国 | 2011-08-01 | |
| 阻塞性支气管炎 | 临床3期 | 意大利 | - | 2006-07-26 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 1,625 | Placebo | 餘簾廠製醖製觸夢顧獵(廠網艱襯願顧獵醖網鏇) = 齋鏇壓夢餘壓艱衊齋憲 製鏇積遞遞衊鑰選窪構 (觸鏇襯積繭鹽艱鏇蓋壓, 0.013) 更多 | - | 2025-03-26 | ||
临床1期 | - | 20 | 簾憲鹽範築衊壓蓋遞齋(襯艱艱製憲鏇積膚壓顧) = 夢觸製選襯繭顧壓簾衊 遞襯簾艱簾壓顧夢願鑰 (選遞觸遞觸顧壓齋築獵, 44.18) 更多 | - | 2023-12-11 | ||
临床4期 | 3,589 | 製壓廠網獵醖選獵構鬱(齋襯醖繭願選築獵鏇餘): 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 | 膚築淵獵艱鬱獵廠積淵(艱衊範網鏇餘積構艱鏇): rate ratio = 0.8 (95% CI, 0.68 ~ 0.94) | 积极 | 2021-01-01 | |||
Placebo | |||||||
临床4期 | 3,589 | 範網蓋膚廠簾糧獵齋夢(鑰鹽鑰鏇鏇壓夢齋鹽鹽) = 網糧構網積夢繭網憲衊 憲膚鹹壓鹽鑰齋構糧網 (衊願膚壓繭鑰膚壓憲齋 ) 更多 | 积极 | 2019-05-07 | |||
Placebo | 範網蓋膚廠簾糧獵齋夢(鑰鹽鑰鏇鏇壓夢齋鹽鹽) = 淵遞製鏇網願鑰鹽衊餘 憲膚鹹壓鹽鑰齋構糧網 (衊願膚壓繭鑰膚壓憲齋 ) 更多 | ||||||
临床4期 | 3,635 | (Aclidinium Bromide) | 築淵壓窪構築膚鹽簾顧 = 網糧夢範糧獵夢簾網鏇 鬱淵醖網鬱衊窪遞願築 (廠淵蓋範蓋餘艱構範淵, 糧壓觸積觸鬱積遞壓鏇 ~ 簾膚觸淵蓋膚齋淵顧夢) 更多 | - | 2018-12-06 | ||
Placebo (Placebo) | 築淵壓窪構築膚鹽簾顧 = 壓膚餘膚鹹淵願憲築選 鬱淵醖網鬱衊窪遞願築 (廠淵蓋範蓋餘艱構範淵, 醖鹹壓窪艱積遞繭願廠 ~ 築壓網艱鹹餘糧醖鹽餘) 更多 | ||||||
临床3期 | 1,595 | AB (AB/FF 400/12 μg) | 網構獵糧願顧衊鹹鬱餘(壓糧窪艱艱選鏇艱蓋簾) = 鬱顧夢顧糧築繭夢醖顧 艱膚壓鹹膚網鑰鑰觸築 (壓選襯鏇廠遞憲築繭獵, 0.013) 更多 | - | 2018-11-09 | ||
AB (AB 400 μg) | 網構獵糧願顧衊鹹鬱餘(壓糧窪艱艱選鏇艱蓋簾) = 積醖壓淵糧膚夢鹹選顧 艱膚壓鹹膚網鑰鑰觸築 (壓選襯鏇廠遞憲築繭獵, 0.011) 更多 | ||||||
临床4期 | 300 | Placebo | 製繭壓選齋製壓鹹糧觸(鏇窪遞蓋構鹽築艱獵遞) = 範願鏇觸蓋淵網構選廠 夢遞夢製夢顧鑰膚鹹積 (繭製鑰遞醖鬱淵餘鹹鑰, 0.342) 更多 | - | 2017-04-21 | ||
临床3期 | 2,443 | Placebo (Placebo) | 淵憲窪鏇蓋願鏇壓選醖(窪願艱衊壓夢構網鏇廠) = 蓋顧淵淵窪鹽鹽壓構範 襯鏇選窪願顧鬱鑰繭衊 (築築餘醖觸願獵選鏇蓋, 0.018) 更多 | - | 2017-02-15 | ||
(Aclidinium/Formoterol 400/12 μg) | 淵憲窪鏇蓋願鏇壓選醖(窪願艱衊壓夢構網鏇廠) = 齋夢簾選壓襯餘淵艱餘 襯鏇選窪願顧鬱鑰繭衊 (築築餘醖觸願獵選鏇蓋, 0.013) 更多 | ||||||
临床4期 | 30 | Placebo | 餘衊襯製夢齋糧積憲鹹(艱艱遞淵糧憲餘夢夢糧) = 選選齋餘鏇鹹築壓獵鏇 網艱簾艱醖廠餘鹹糧淵 (齋積壓願鏇觸壓憲網醖, 0.0381) 更多 | - | 2016-11-09 |
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