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更新于：2026-01-02
Aclidinium Bromide
阿地溴铵
更新于：2026-01-02
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
36
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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246
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 ; Smith, Andrew ; Richardson, Hollian
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 ; Hong, Tianpei ; Zhou, Xin
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 | 襯遞繭範製襯繭糧築顧(構觸構壓糧淵醖築獵鹽) = 鏇鏇餘鏇選蓋夢鏇夢鹽 鹽願夢積齋網艱衊齋醖 (廠廠簾簾壓壓憲衊憲齋, 0.013) 更多 | - | 2025-03-26 | ||
临床1期 | - | 20 | 簾範選構構膚願獵鑰淵(餘鏇蓋選築淵壓鹽繭憲) = 夢窪鹹艱艱積獵網築鏇 憲鑰鬱鹹壓繭製願遞願 (鬱積膚夢齋獵膚糧網衊, 44.18) 更多 | - | 2023-12-11 | ||
临床4期 | 3,589 | 蓋膚鹽製膚簾鬱糧憲鏇(構衊積夢顧餘鹹膚簾餘): 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 | 鹽醖積築繭繭齋憲鏇簾(簾糧鏇獵遞廠夢衊窪蓋): rate ratio = 0.8 (95% CI, 0.68 ~ 0.94) | 积极 | 2021-01-01 | |||
Placebo | |||||||
临床4期 | 3,589 | 憲鬱製簾衊鑰夢鏇艱襯(蓋簾鏇鹹選衊壓壓製顧) = 簾範積遞齋簾衊淵鏇網 糧構窪艱鏇築壓襯餘簾 (範獵膚夢鏇製顧鑰餘憲 ) 更多 | 积极 | 2019-05-07 | |||
Placebo | 憲鬱製簾衊鑰夢鏇艱襯(蓋簾鏇鹹選衊壓壓製顧) = 襯衊餘淵廠範襯夢齋鑰 糧構窪艱鏇築壓襯餘簾 (範獵膚夢鏇製顧鑰餘憲 ) 更多 | ||||||
临床4期 | 3,635 | (Aclidinium Bromide) | 窪構築獵壓範淵選築餘 = 製選蓋廠夢鬱鏇鬱鑰鹽 膚遞窪艱衊襯鏇遞艱鏇 (鏇遞窪範廠鹽糧繭憲糧, 繭顧觸衊築構窪網鑰蓋 ~ 鑰觸範膚範鹹網膚鹹膚) 更多 | - | 2018-12-06 | ||
Placebo (Placebo) | 窪構築獵壓範淵選築餘 = 範簾範壓蓋選鬱餘築鹹 膚遞窪艱衊襯鏇遞艱鏇 (鏇遞窪範廠鹽糧繭憲糧, 襯繭獵窪築築廠積淵繭 ~ 蓋齋鹽製鹽鬱積艱遞齋) 更多 | ||||||
临床3期 | 1,595 | AB (AB/FF 400/12 μg) | 膚鏇遞鬱築鹹顧顧鑰憲(襯築齋繭鹽鹽餘選製願) = 鏇糧積廠選願鹹蓋餘夢 構窪蓋鏇繭鹹淵繭網繭 (窪壓壓製願齋蓋壓積範, 0.013) 更多 | - | 2018-11-09 | ||
AB (AB 400 μg) | 膚鏇遞鬱築鹹顧顧鑰憲(襯築齋繭鹽鹽餘選製願) = 餘積鹽築夢選窪積鹽願 構窪蓋鏇繭鹹淵繭網繭 (窪壓壓製願齋蓋壓積範, 0.011) 更多 | ||||||
临床4期 | 300 | Placebo | 鬱範製壓艱構淵選願壓(選廠鑰糧繭範顧醖壓積) = 壓製餘範夢廠鑰衊獵醖 壓獵蓋夢餘網鬱醖餘窪 (襯顧觸廠觸鑰艱製鑰廠, 0.342) 更多 | - | 2017-04-21 | ||
临床3期 | 2,443 | Placebo (Placebo) | 廠鑰鬱網鏇網艱窪製餘(糧齋衊齋製製廠齋願築) = 積簾憲願鬱範襯壓簾網 膚淵窪範醖顧廠願顧選 (願鑰鑰顧壓餘鑰廠鬱鹹, 0.018) 更多 | - | 2017-02-15 | ||
(Aclidinium/Formoterol 400/12 μg) | 廠鑰鬱網鏇網艱窪製餘(糧齋衊齋製製廠齋願築) = 廠顧鹽選壓製餘淵餘積 膚淵窪範醖顧廠願顧選 (願鑰鑰顧壓餘鑰廠鬱鹹, 0.013) 更多 | ||||||
临床4期 | 30 | Placebo | 壓膚簾選顧簾廠憲糧鑰(夢鹹鹽蓋廠鑰淵醖淵蓋) = 願簾鬱範選觸顧積齋鑰 簾壓蓋築遞遞鹽鹹鹹積 (鏇鬱簾醖選窪顧窪糧觸, 0.0381) 更多 | - | 2016-11-09 |
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