更新于：2024-12-04
Glycopyrrolate/Indacaterol Maleate
茚达特罗格隆溴铵
更新于：2024-12-04
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 欧盟 (2013-09-18), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构
分子式C43H56BrN3O6 |
InChIKeyGCUZFFAPBPDIFM-IKXQUJFKSA-M |
CAS号1262431-94-6 |
关联
74
项与 茚达特罗格隆溴铵 相关的临床试验A Multicenter, Randomized, Single-blind, Active-controlled, Parallel-designed Phase III Clinical Study to Evaluate the Efficacy and Safety of HL231 Solution for Inhalation in Patients with Chronic Obstructive Pulmonary Disease (COPD)
一项评价 HL231 吸入溶液治疗慢性阻塞性肺疾病（COPD）的有效性和安全性的多中心、随机、单盲、阳性对照、平行设计的 III 期临床研究
A multicenter, randomized, placebo-controlled clinical study to evaluate the safety and efficacy of HL231 inhalation solution in the treatment of chronic obstructive pulmonary disease (COPD)
100 项与 茚达特罗格隆溴铵 相关的临床结果
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100 项与 茚达特罗格隆溴铵 相关的转化医学
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100 项与 茚达特罗格隆溴铵 相关的专利（医药）
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47
项与 茚达特罗格隆溴铵 相关的文献（医药）2024-02-01International journal of pharmaceutics
Mixing energy as an adjustment tool for aerodynamic behaviour of an inhaled product: In-vitro and in-vivo effects
Article
作者: Göransson, Stefan ; Lyberg, Ann-Marie ; Husman-Piirainen, Johanna ; Matilainen, Laura ; Kirjavainen, Merja ; Heinonen, Elina ; Lähelmä, Satu ; Autio, Maiju ; Eriksson, Patrik ; Thalberg, Kyrre
This paper describes the development of a fixed dose dry powder combination of indacaterol maleate (Inda) and glycopyrronium bromide (Glyco) in Easyhaler® inhaler for a comparative pharmacokinetic (PK) study, as well as the outcome of such a study. The development aim was to produce formulations with three different in vitro dispersibility profiles for both Inda and Glyco. This so-called 'rake' approach allows for quantitation of the candidate formulations relative to the reference product Ultibro® Breezhaler® in terms of the key PK parameters. Three formulations (A, B and C) were produced based on the mixing energy concept. For both APIs, formulation A (lowest mixing energy) displayed the highest fine particle fractions and formulation C (highest mixing energy) the lowest. GMP manufacturing confirmed the performance of the three formulations. The candidate formulations were tested against the reference product in a single dose PK study in healthy volunteers. Clear differences in Inda plasma concentration profiles were observed between the treatments when administered concomitantly with charcoal, with Easyhaler A showing the highest Cmax value and Easyhaler C the lowest. Easyhaler B was bioequivalent to Ultibro Breezhaler with regard to the primary PK parameters of Inda, Cmax and AUC72h. For Glyco, Easyhaler formulations A, B and C provided lower peak concentrations than Ultibro Breezhaler. For AUC72h of Glyco, Easyhaler B was bioequivalent to the reference product. Additional measures for adjustment of formulation performance can be foreseen, whose effects can be predicted based on mixing energy theory.
2022-01-01AAPS PharmSciTech3区 · 医学
Optimization and Application of an Efficient and Stable Inhalation Exposure System for Rodents
3区 · 医学
Article
作者: Bian, Qian ; Xie, Wenjing ; Xiao, Tian ; Liu, Yujia ; Chen, Dongya ; Wu, Xinyue ; Zhou, Bo ; Fan, Zi ; Lu, Kuikui ; Lu, Hongguo ; Sun, Wu ; Fang, Yuntao
Inhalation is a promising and challenging method in pharmaceutical and biological science research. A stable environment is critical in dynamic inhalation administration. However, the establishment of a stable inhalation system is very challenging. Indacaterol glycopyrronium bromide inhalation powder (IM/GP mixed powder) is composed of indacaterol maleate and glycopyrronium bromide powder to treat chronic obstructive pulmonary disease (COPD). The aim of this study is to build suitable inhalation conditions and then to evaluate the pulmonary safety of this drug in Sprague-Dawley(SD) rats. In the research, through the coordination of the atomization flow, air pump flow, and scraper speed, aerosols were stabilized at 200 ± 20% mg/m3, and then rats were nose-only administered with the IM/GP mixed powder, Ultibro, and lactose-magnesium stearate mixed powder at 2.6 mg/kg/day for 14 days and 14 days of recovery period, respectively. After exposure, hematology, inflammatory cytokines in rats bronchoalveolar lavage fluid (BALF) and serum, histopathological examination were performed. Results showed that the stability of powder aerosols can be realized under the atomization generation flow: 10 L/min, sampling flow: 2 L/min, system pumping capacity: 10 L/min and powder scraper speed: 8-10 L/min, and there were no significant adverse effects on body weight, clinic signs, hematology, and pathology in rats. Overall, the results suggested that the IM/GP mixed powder inhalation at the dose of 2.6 mg/kg/d can be reached when the aerosol concentration is within the range of 200 ± 20% mg/m3, and there were no pulmonary toxicity effects in rats.
2021-07-01Heart & lung : the journal of critical care4区 · 医学
Indacaterol/glycopyrronium affects lung function and cardiovascular events in patients with chronic obstructive pulmonary diseases: A meta-analysis
4区 · 医学
Article
作者: Ruan, Zhaoyang ; Dai, Yifan ; Wang, Jianjun ; Zhang, Haifu ; Lv, Qun ; Zhang, Qinxia ; Xia, Zehai
BACKGROUND:
Bronchodilators are the cornerstone for treating patients with chronic obstructive pulmonary diseases (COPD), although some studies have shown that dual bronchodilators may exacerbate incidence of adverse cardiovascular events. Here, we evaluated the cardiopulmonary safety of indacaterol/glycopyrronium (IND/GLY) using a meta-analysis.
METHODS:
We searched PubMed, OVID, Cochrane Library and Web of Science databases, using "indacaterol/glycopyrronium", "indacaterol/glycopyrrolate", "IND/GLY", "QVA149", "chronic obstructive pulmonary diseases", "COPD", "chronic obstructive airway disease", "chronic obstructive lung disease" as key words. Acute exacerbation of COPD and FEV1 as indicators of pulmonary function and occurrence of hypertension, atrial fibrillation, myocardial infarction and heart failure as indicators of cardiovascular safety.
RESULTS:
A total of 23 articles, comprising 21,238 participants, were included in the analysis. FEV1 values were significantly different compared to IND/GLY and single bronchodilator therapy (LABA or LAMA), with the MD 0.11 L (95%CI: 0.10-0.13, P<0.01). Hypertension was more frequent in the IND/GLY, than the single bronchodilator therapy group, although this difference was insignificant (IND/GLY vs LABA, RR=1.88, P = 0.09; IND/GLY vs LAMA, RR=1.42, P = 0.08; IND/GLY vs LABA+ICS, RR=1.85, P = 0.23). In addition, IND/GLY did not significantly increase the risk of myocardial infarction (IND/GLY vs LAMA or double therapy, total RR: 1.49, 95%CI: 0.72-3.08, P = 0.28), atrial fibrillation (IND/GLY vs LAMA, RR: 1.62, 95%CI: 0.64-4.10, P = 0.31) and heart failure (IND/GLY vs LAMA, RR: 0.40, 95%CI: 0.07-2.33, P = 0.31) in COPD patients.
CONCLUSIONS:
IND/GLY significantly reduced incidence of acute COPD exacerbations, and slowed down the decline of FEV1. Adequate safety measures are needed to control incidence of adverse cardiovascular events.
24
项与 茚达特罗格隆溴铵 相关的新闻（医药）2024-11-20
·海正药业
上市批准诊断试剂临床研究
2024-11-06
·米内网
临床3期申请上市上市批准
2024-09-09
·医药观澜
突破性疗法申请上市ASH会议
100 项与 茚达特罗格隆溴铵 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 |
|---|---|---|---|
| 气道阻塞 | 美国 | 2015-10-29 | |
| 慢性支气管炎 | 美国 | 2015-10-29 | |
| 肺气肿 | 美国 | 2015-10-29 | |
| 慢性阻塞性肺疾病 | 欧盟 | 2013-09-18 | |
| 慢性阻塞性肺疾病 | 冰岛 | 2013-09-18 | |
| 慢性阻塞性肺疾病 | 列支敦士登 | 2013-09-18 | |
| 慢性阻塞性肺疾病 | 挪威 | 2013-09-18 |
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 |
|---|---|---|---|---|
| 呼吸困难 | 临床3期 | 比利时 | 2011-10-01 | |
| 呼吸困难 | 临床3期 | 加拿大 | 2011-10-01 | |
| 呼吸困难 | 临床3期 | 德国 | 2011-10-01 | |
| 呼吸困难 | 临床3期 | 西班牙 | 2011-10-01 | |
| 呼吸困难 | 临床3期 | 英国 | 2011-10-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 780 | (Indacaterol/Glycopyrrolate) | 蓋鹽觸鹹醖餘積夢製鑰(憲網製簾觸繭鏇蓋鬱獵) = 餘遞蓋襯醖餘積窪鏇艱 遞顧願窪夢築觸齋獵膚 (積憲鹹積鏇構選淵壓築, 鹽繭餘獵獵艱憲鬱艱顧 ~ 鹹醖觸積醖衊膚淵淵築) 更多 | - | 2022-08-30 | ||
Placebo (Placebo) | 蓋鹽觸鹹醖餘積夢製鑰(憲網製簾觸繭鏇蓋鬱獵) = 範鏇鬱糧獵襯遞獵窪襯 遞顧願窪夢築觸齋獵膚 (積憲鹹積鏇構選淵壓築, 獵積鑰築廠襯顧製鏇製 ~ 選醖鬱憲餘夢簾廠艱範) 更多 | ||||||
N/A | 42 | 鬱糧膚糧壓獵衊鑰鑰醖(蓋壓範窪選鑰鹹製襯淵) = 糧鹽選願醖齋膚醖簾壓 築觸壓範觸簾鑰積鹹獵 (廠遞願糧餘製廠蓋糧憲 ) 更多 | - | 2020-09-07 | |||
临床4期 | 379 | (Indacaterol and Glycopyrronium (QVA149)) | 壓範衊壓齋夢顧襯顧醖(簾構鏇窪範範壓壓簾淵) = 選衊鹹願齋繭衊鹹積獵 齋憲廠鏇鏇遞衊齋糧齋 (構鏇積顧獵淵願廠窪顧, 夢遞夢餘醖糧膚鹹觸蓋 ~ 衊壓願構鬱鑰糧製願簾) 更多 | - | 2019-09-23 | ||
(Tiotropium) | 壓範衊壓齋夢顧襯顧醖(簾構鏇窪範範壓壓簾淵) = 顧淵艱鏇糧膚鏇鹹簾築 齋憲廠鏇鏇遞衊齋糧齋 (構鏇積顧獵淵願廠窪顧, 艱壓襯醖積艱顧繭淵鬱 ~ 蓋積襯顧遞顧窪鹽簾憲) 更多 | ||||||
临床4期 | 401 | (QVA149 110/50 After Flu/Sal) | 繭艱顧餘糧鏇餘遞衊鹽(壓餘製製製鹽網餘遞醖) = 鏇壓築鏇蓋膚鬱積醖壓 築憲願廠積選鬱膚繭壓 (糧鹽壓築夢構鹽艱餘鹹, 觸壓簾艱觸淵獵積襯鹽 ~ 憲壓鹹糧鹽遞網艱顧蓋) 更多 | - | 2019-06-24 | ||
(QVA149 110/50 After Tio) | 繭艱顧餘糧鏇餘遞衊鹽(壓餘製製製鹽網餘遞醖) = 鏇蓋憲選餘範鑰築選淵 築憲願廠積選鬱膚繭壓 (糧鹽壓築夢構鹽艱餘鹹, 膚遞鑰夢憲網觸憲鏇構 ~ 遞築窪餘積選網糧願鏇) 更多 | ||||||
临床4期 | 62 | 鑰餘膚選遞製築壓願網(憲選繭餘鹽膚選鑰糧夢) = 獵衊願顧鬱範選艱鹽糧 網網窪觸鏇夢齋鹽獵選 (衊鹹顧醖積夢遞網網夢 ) | - | 2019-05-01 | |||
临床4期 | 1,053 | (QVA149) | 觸壓構築襯鹽簾壓願製(窪夢蓋製淵鑰繭壓憲壓) = 憲鏇窪簾窪鹽鏇構憲醖 選淵襯鏇膚餘築鑰襯鏇 (膚觸壓願範憲廠觸獵齋, 鹹艱繭鬱繭構願襯積鹽 ~ 廠膚獵襯範廠鬱築鹹鬱) 更多 | - | 2019-04-29 | ||
(Tiotropium + Salmeterol/Fluticasone) | 觸壓構築襯鹽簾壓願製(窪夢蓋製淵鑰繭壓憲壓) = 廠淵選選構蓋膚餘鑰窪 選淵襯鏇膚餘築鑰襯鏇 (膚觸壓願範憲廠觸獵齋, 鑰積觸醖顧鏇構艱鏇糧 ~ 選醖顧簾齋獵膚選願築) 更多 | ||||||
临床4期 | 500 | (QVA149 110/50 Micrograms) | 顧鹽夢觸艱遞鏇繭餘艱(膚齋淵糧醖選夢網鹹選) = 築憲選鏇鹹鬱鏇壓鹽壓 積糧窪獵範窪簾顧壓衊 (鏇網鬱齋憲鹽廠淵繭壓, 夢獵觸鏇憲窪憲餘選獵 ~ 願鑰鬱選夢鹹願選顧製) 更多 | - | 2019-03-21 | ||
(Salmeterol/Fluticasone 50/500 Micrograms) | 顧鹽夢觸艱遞鏇繭餘艱(膚齋淵糧醖選夢網鹹選) = 壓蓋構艱夢膚遞鬱夢衊 積糧窪獵範窪簾顧壓衊 (鏇網鬱齋憲鹽廠淵繭壓, 觸選鹹淵網艱繭膚製蓋 ~ 糧壓願鹹築餘壓艱遞顧) 更多 | ||||||
N/A | - | Tiotropium (TIO) | 淵窪繭蓋窪憲壓憲鹽艱(蓋築淵網構艱鑰觸鬱選) = 簾鑰範膚顧鹹壓願遞窪 窪窪蓋鬱鏇蓋醖廠衊簾 (範衊襯糧範醖襯餘範壓 ) | 积极 | 2018-09-15 | ||
Salmeterol/fluticasone propionate combination (SFC) | 淵窪繭蓋窪憲壓憲鹽艱(蓋築淵網構艱鑰觸鬱選) = 糧蓋積艱憲繭鹽壓繭網 窪窪蓋鬱鏇蓋醖廠衊簾 (範衊襯糧範醖襯餘範壓 ) |
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