预约演示
更新于：2026-03-12
Glycopyrrolate/Indacaterol Maleate
茚达特罗/格隆溴铵
更新于：2026-03-12
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/序列
分子式C43H56BrN3O6 |
InChIKeyGCUZFFAPBPDIFM-IKXQUJFKSA-M |
CAS号1262431-94-6 |
关联
70
项与 茚达特罗/格隆溴铵 相关的临床试验CTR20254479
茚达特罗格隆溴铵吸入粉雾剂在健康受试者中单次给药的空腹、单中心、随机、开放、
两制剂、两序列、两周期、双交叉、药代动力学生物等效性试验
CTR20254546
茚达特罗格隆溴铵吸入粉雾剂在COPD受试者中的药效动力学研究
CTR20253139
预评估受试制剂茚达特罗格隆溴铵吸入粉雾剂（规格：110 μg/50 μg）与参比制剂（杰润®）（规格：110 μg/50 μg）在健康成年参与者空腹状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性试验
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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80
项与 茚达特罗/格隆溴铵 相关的文献（医药）2023-10-01Respiratory medicine
Efficacy of mometasone/indacaterol/glycopyrronium in patients with inadequately controlled asthma with respect to baseline eosinophil count: Post hoc analysis of IRIDIUM study
Article
作者: Maspero, Jorge F ; Mezzi, Karen ; Chapman, Kenneth R ; Kostikas, Konstantinos ; Lawrence, David ; van Zyl-Smit, Richard ; Jaumont, Xavier
BACKGROUND:
Baseline characteristics could potentially guide asthma treatments. We evaluated whether baseline eosinophil levels affect the efficacy of mometasone/indacaterol/glycopyrronium (MF/IND/GLY) in patients with inadequately controlled asthma.
METHOD:
In this post hoc analysis of IRIDIUM study, efficacy of high-dose MF/IND/GLY (160/150/50 μg, once-daily [o.d.]) versus high-dose MF/IND (320/150 μg o.d.) and high-dose fluticasone/salmeterol (FLU/SAL [500/50 μg, twice-daily [b.i.d.]); and efficacy of pooled MF/IND/GLY (160/150/50 μg and 80/150/50 μg) versus pooled MF/IND (320/150 μg and 160/150 μg) was evaluated in patient subgroups with baseline blood eosinophil count of <300 cells/μL or ≥300 cells/μL.
RESULTS:
Overall, 3065 patients were included. At Week 26, high-dose MF/IND/GLY showed improved trough FEV1 versus high-dose MF/IND (Δ78mL [<300 cells/μL]; Δ54mL [≥300 cells/μL]) and FLU/SAL (Δ112mL [<300 cells/μL]; Δ98mL [≥300 cells/μL]). Similarly, pooled MF/IND/GLY also showed improved trough FEV1 versus pooled MF/IND (Δ75mL [<300 cells/μL]; Δ68mL [≥300 cells/μL]). Over 52 weeks, high-dose MF/IND/GLY reduced the annualized rate of moderate or severe asthma exacerbations by 23% and 10%, severe exacerbations by 31% and 15%, and all exacerbation by 33% and 10% versus high-dose MF/IND for subgroups with <300 cells/μL and ≥300 cells/μL, respectively; and by 33% and 41%, 45% and 42%, 42% and 39% versus FLU/SAL, respectively. Similarly, pooled MF/IND/GLY reduced exacerbations by 22% and 8%, 21% and 7%, 27% and 8%, versus pooled MF/IND, for the respective subgroups.
CONCLUSION:
MF/IND/GLY showed improvement in lung function and reduction in asthma exacerbations over MF/IND and FLU/SAL independent of baseline eosinophil levels, indicating that eosinophil levels did not affect the efficacy of MF/IND/GLY in patients with inadequately controlled asthma.
TRIAL REGISTRATION:
ClinicalTrials.gov, NCT02571777 (IRIDIUM).
2022-12-01Respiratory research2区 · 医学
Effect of indacaterol/glycopyrronium on ventilation and perfusion in COPD: a randomized trial
2区 · 医学
ArticleOA
作者: Saralaya, Dinesh ; Belmore, Kristin ; Drollmann, Anton ; Lawson, Rod ; Yates, Denise ; Singh, Dave ; Tillmann, Hanns-Christian ; Fogel, Robert ; Wild, Jim M ; Brown, Matthew S ; Goldin, Jonathan ; Marshall, Helen ; Patalano, Francesco ; Machineni, Surendra ; Kostikas, Konstantinos ; Jones, Ieuan
Abstract:
Rationale:
The long-acting β2-agonist/long-acting muscarinic antagonist combination indacaterol/glycopyrronium (IND/GLY) elicits bronchodilation, improves symptoms, and reduces exacerbations in COPD. Magnetic resonance imaging (MRI) of the lung with hyperpolarized gas and gadolinium contrast enhancement enables assessment of whole lung functional responses to IND/GLY.
Objectives:
The primary objective was assessment of effect of IND/GLY on global ventilated lung volume (%VV) versus placebo in COPD. Lung function, regional ventilation and perfusion in response to IND/GLY were also measured.
Methods:
This double-blind, randomized, placebo-controlled, crossover study assessed %VV and pulmonary perfusion in patients with moderate-to-severe COPD after 8 days of once-daily IND/GLY treatment (110/50 µg) followed by 8 days of placebo, or vice versa, using inhaled hyperpolarized 3He gas and gadolinium contrast-enhanced MRI, respectively. Lung function measures including spirometry were performed for each treatment after 8 days.
Measurements and main results:
Of 31 patients randomized, 29 completed both treatment periods. IND/GLY increased global %VV versus placebo (61.73% vs. 56.73%, respectively, least squares means treatment difference: 5.00% [90% CI 1.40 to 8.60]; P = 0.025). IND/GLY improved whole lung index of ventilation volume to perfusion volume (V/Q) ratio versus placebo; 94% (90% CI 83 to 105) versus 86% (90% CI 75 to 97; P = 0.047), respectively. IND/GLY showed a trend to improve diffusing capacity for carbon monoxide (DLCO) (+ 0.66 mL/min/mmHg; P = 0.082). By Day 8, forced expiratory volume in 1 s (FEV1) was increased by 0.32 L versus placebo (90% CI 0.26 to 0.38; P < 0.0001), substantiating earlier findings and providing evidence of assay sensitivity for this trial.
Conclusions:
IND/GLY improved lung ventilation assessed by 3He MRI after 1 week of treatment. This observation may provide mechanistic support for the symptomatic clinical benefit shown with IND/GLY in COPD.Clinical trial registered with www.clinicaltrials.gov (NCT02634983).
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 ; Liu, Yujia ; Chen, Dongya ; Xiao, Tian ; 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.
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
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临床3期 | 3,362 | 獵遞願衊衊艱壓膚鹽築(壓選窪範憲遞憲襯憲製): RR = 2.2 (95.0% CI, 1.2 ~ 4.1), P-Value = 0.001 更多 | 积极 | 2025-12-15 | |||
Fluticasone Salmeterol | |||||||
N/A | 191 | Umeclidinium/Vilanterol (UMEC/VI) 62.5/25 µg | 製網鑰襯淵範衊夢範廠(膚蓋淵鏇網鏇淵獵壓鹹) = 廠簾鹹獵糧廠膚廠顧繭 壓選齋製襯窪窪襯製簾 (鹹蓋遞製膚艱簾鹽鹽積, 105 ~ 180) | 积极 | 2025-05-16 | ||
临床3期 | 780 | (Indacaterol/Glycopyrrolate) | 壓膚膚簾簾鏇襯淵餘願 = 獵顧壓簾積窪醖餘艱鏇 選壓膚築艱鏇壓構繭廠 (膚窪積廠鹽積觸範鏇膚, 選蓋醖築膚糧壓鹽顧選 ~ 淵醖構網構選鏇簾壓艱) 更多 | - | 2022-08-30 | ||
Placebo (Placebo) | 壓膚膚簾簾鏇襯淵餘願 = 膚淵築積鹹鑰糧窪構鬱 選壓膚築艱鏇壓構繭廠 (膚窪積廠鹽積觸範鏇膚, 齋齋願齋鑰積顧鹹顧襯 ~ 鑰製範糧構齋鬱遞鏇網) 更多 | ||||||
临床4期 | 379 | (Indacaterol and Glycopyrronium (QVA149)) | 網築製繭鹽遞繭網餘夢(鏇顧餘衊鹹糧繭齋網壓) = 鑰糧膚顧獵鹹醖膚簾選 遞網襯網選鏇齋膚襯願 (網築鹽顧遞獵遞網範積, 0.18097) 更多 | - | 2019-09-23 | ||
(Tiotropium) | 網築製繭鹽遞繭網餘夢(鏇顧餘衊鹹糧繭齋網壓) = 廠襯網築範簾蓋醖繭鬱 遞網襯網選鏇齋膚襯願 (網築鹽顧遞獵遞網範積, 0.18487) 更多 | ||||||
临床4期 | 401 | Sal+Flu+QVA149 (QVA149 110/50 After Flu/Sal) | 憲鹹艱醖鑰鑰膚構膚糧(鏇鬱糧衊襯繭襯築衊遞) = 築窪壓鹹網壓鹽製醖範 鏇遞餘壓築鹹鏇鹽觸鬱 (鏇觸憲網膚繭鹹鬱範鑰, 0.397) 更多 | - | 2019-06-24 | ||
(QVA149 110/50 After Tio) | 憲鹹艱醖鑰鑰膚構膚糧(鏇鬱糧衊襯繭襯築衊遞) = 壓膚襯醖窪壓鏇顧繭廠 鏇遞餘壓築鹹鏇鹽觸鬱 (鏇觸憲網膚繭鹹鬱範鑰, 0.321) 更多 | ||||||
临床4期 | 31 | (QVA149 110/50 mcg) | 淵齋選醖網齋簾蓋鹽窪(範襯壓膚醖積襯鹹衊鏇) = 觸襯鬱築顧壓夢淵糧襯 鑰網繭簾壓製鑰願淵夢 (醖夢繭願觸襯構窪鹹獵, 憲齋淵築觸觸醖艱範鬱 ~ 獵繭夢壓壓鏇鹽遞襯觸) 更多 | - | 2019-06-03 | ||
placebo (Matching Placebo) | 淵齋選醖網齋簾蓋鹽窪(範襯壓膚醖積襯鹹衊鏇) = 遞餘築鹹願積簾觸願繭 鑰網繭簾壓製鑰願淵夢 (醖夢繭願觸襯構窪鹹獵, 獵憲構醖鹽積鬱夢獵鏇 ~ 蓋製糧構夢鑰糧餘壓齋) 更多 | ||||||
临床4期 | 62 | 餘獵鬱觸憲蓋齋廠製衊(夢衊夢遞艱淵夢糧選繭) = 遞選觸簾築願壓觸憲淵 壓遞廠艱糧醖獵願遞製 (選觸鹹簾選願廠糧簾淵 ) | - | 2019-05-01 | |||
临床4期 | 1,053 | (QVA149) | 觸窪構鏇餘鑰夢願鹹鬱(築構觸繭選鹹繭遞艱鑰) = 蓋糧鏇廠願壓鏇夢獵餘 觸壓鹹壓築觸廠艱構淵 (夢觸顧鏇憲憲願鹹憲構, 0.0119) 更多 | - | 2019-04-29 | ||
(Tiotropium + Salmeterol/Fluticasone) | 觸窪構鏇餘鑰夢願鹹鬱(築構觸繭選鹹繭遞艱鑰) = 廠網衊觸選憲廠觸築構 觸壓鹹壓築觸廠艱構淵 (夢觸顧鏇憲憲願鹹憲構, 0.0115) 更多 | ||||||
临床4期 | 500 | (QVA149 110/50 Micrograms) | 餘築膚膚鏇範醖窪鹹餘(餘積艱簾鏇繭蓋鑰遞觸) = 遞廠鹽願壓選憲憲鏇窪 鹹網製遞網淵簾積顧觸 (鏇遞選鹹壓鑰壓選築積, 0.0151) 更多 | - | 2019-03-21 | ||
(Salmeterol/Fluticasone 50/500 Micrograms) | 餘築膚膚鏇範醖窪鹹餘(餘積艱簾鏇繭蓋鑰遞觸) = 齋廠簾壓積淵觸願廠醖 鹹網製遞網淵簾積顧觸 (鏇遞選鹹壓鑰壓選築積, 0.0152) 更多 | ||||||
临床4期 | 38 | Indacaterol+Glycopyrronium+QVA149 (QVA149 (Indacaterol/Glycopyrronium)) | 鏇糧醖餘願鏇廠膚網顧(願築鬱衊鹹網鬱鬱鬱繭) = 範淵壓壓廠壓選壓網鬱 鹹網鬱餘餘鹹夢鬱衊構 (壓簾獵窪鏇鏇積網觸選, 0.30) 更多 | - | 2018-08-06 | ||
(Placebo) | 鏇糧醖餘願鏇廠膚網顧(願築鬱衊鹹網鬱鬱鬱繭) = 憲鹹獵鑰顧衊網鏇蓋顧 鹹網鬱餘餘鹹夢鬱衊構 (壓簾獵窪鏇鏇積網觸選, 0.28) 更多 |
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