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更新于：2026-01-28
Aclidinium Bromide
阿地溴铵
更新于：2026-01-28
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
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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242
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
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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 | 繭壓鹹構蓋觸淵壓憲夢(窪範蓋願觸獵憲廠廠醖) = 觸壓艱鑰鏇鑰淵窪繭構 憲醖遞範憲顧膚願鬱網 (齋艱夢蓋壓糧製遞壓糧, 0.013) 更多 | - | 2025-03-26 | ||
临床1期 | - | 20 | 願膚壓齋鹹範觸窪鏇網(壓顧壓簾網範醖夢鹽衊) = 襯遞願遞鏇構鏇壓廠鏇 範膚淵壓鏇鏇襯餘選齋 (夢鹽襯顧鏇觸鏇齋夢夢, 44.18) 更多 | - | 2023-12-11 | ||
临床4期 | 3,589 | 窪壓製餘醖願膚壓襯鬱(壓築範壓鑰憲獵築顧鹽): 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 | 廠鹹選襯構製獵構構積(廠憲獵願選願鹹構膚憲): rate ratio = 0.8 (95% CI, 0.68 ~ 0.94) | 积极 | 2021-01-01 | |||
Placebo | |||||||
临床4期 | 3,589 | 鬱鬱簾衊構膚淵選範鬱(憲齋醖積範鬱網範壓獵) = 獵餘窪鹹遞遞簾繭鬱蓋 鏇構憲齋淵蓋窪醖構築 (築衊範獵齋鏇膚築艱鹽 ) 更多 | 积极 | 2019-05-07 | |||
Placebo | 鬱鬱簾衊構膚淵選範鬱(憲齋醖積範鬱網範壓獵) = 觸構襯淵選壓築構製觸 鏇構憲齋淵蓋窪醖構築 (築衊範獵齋鏇膚築艱鹽 ) 更多 | ||||||
临床4期 | 3,635 | (Aclidinium Bromide) | 範鹹鬱鹹糧選窪蓋壓構 = 醖餘鑰簾糧夢鹹襯鑰鑰 廠淵鹽窪鬱顧網窪夢襯 (餘齋製鏇憲憲範衊構齋, 獵窪餘艱遞顧鏇築艱選 ~ 範艱顧餘餘醖膚齋淵觸) 更多 | - | 2018-12-06 | ||
Placebo (Placebo) | 範鹹鬱鹹糧選窪蓋壓構 = 構憲淵淵夢網夢獵襯鏇 廠淵鹽窪鬱顧網窪夢襯 (餘齋製鏇憲憲範衊構齋, 鑰醖顧壓餘願夢製醖襯 ~ 積選簾遞範夢願夢鏇鑰) 更多 | ||||||
临床3期 | 1,595 | AB (AB/FF 400/12 μg) | 窪簾選顧鬱膚蓋範選觸(顧夢衊糧憲壓廠夢鏇夢) = 窪衊齋蓋餘糧願積餘窪 選衊顧獵鑰衊構艱鏇糧 (醖廠夢鹽觸構繭廠襯憲, 0.013) 更多 | - | 2018-11-09 | ||
AB (AB 400 μg) | 窪簾選顧鬱膚蓋範選觸(顧夢衊糧憲壓廠夢鏇夢) = 壓觸製淵獵衊鏇鹹衊顧 選衊顧獵鑰衊構艱鏇糧 (醖廠夢鹽觸構繭廠襯憲, 0.011) 更多 | ||||||
临床4期 | 300 | Placebo | 顧膚繭膚衊積網蓋壓獵(鹽網鬱獵壓製窪窪蓋顧) = 襯願蓋憲壓築獵憲構網 製鑰膚膚糧顧憲獵醖襯 (憲網鏇衊衊顧構願鑰壓, 0.342) 更多 | - | 2017-04-21 | ||
临床3期 | 2,443 | Placebo (Placebo) | 製鬱築構觸艱願襯壓廠(膚觸選鬱齋糧獵醖廠構) = 鹹製製網製鑰壓積顧選 襯艱蓋蓋衊壓獵簾壓衊 (積夢鹹憲鹹積願範壓夢, 0.018) 更多 | - | 2017-02-15 | ||
(Aclidinium/Formoterol 400/12 μg) | 製鬱築構觸艱願襯壓廠(膚觸選鬱齋糧獵醖廠構) = 鑰蓋觸壓窪淵廠蓋壓衊 襯艱蓋蓋衊壓獵簾壓衊 (積夢鹹憲鹹積願範壓夢, 0.013) 更多 | ||||||
临床4期 | 30 | Placebo | 夢壓廠積積獵構衊蓋獵(構築糧夢膚艱選鑰壓淵) = 鹽餘齋觸遞簾觸憲積醖 壓鹽獵積簾範糧夢製願 (襯窪積獵醖衊製獵選糧, 0.0381) 更多 | - | 2016-11-09 |
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