预约演示
更新于：2026-02-01
Glycopyrrolate/Indacaterol Maleate
茚达特罗/格隆溴铵
更新于：2026-02-01
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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81
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.
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 ; Lawrence, David ; Kostikas, Konstantinos ; 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).
2023-01-01International journal of chronic obstructive pulmonary disease
Comparative Effectiveness of Umeclidinium/Vilanterol versus Indacaterol/Glycopyrronium on Moderate-to-Severe Exacerbations in Patients with Chronic Obstructive Pulmonary Disease in Clinical Practice in England
Article
作者: Compton, Chris ; Herth, Felix J F ; Czira, Alexandrosz ; Requena, Gema ; Yeap, Jie ; Castillo, Catherine ; Ismaila, Afisi S ; Tritton, Theo ; Banks, Victoria ; Wild, Rosie ; Quint, Jennifer K ; Rothnie, Kieran J ; Wood, Robert
Purpose:
Chronic obstructive pulmonary disease (COPD) exacerbations are associated with significant morbidity and mortality and increased economic healthcare burden for patients with COPD. Long-acting muscarinic antagonist (LAMA)/long-acting β2-agonist (LABA) dual therapy is recommended for patients receiving mono-bronchodilator therapy who experience exacerbations or ongoing breathlessness. This study compared two single-inhaler LAMA/LABA dual therapies, umeclidinium/vilanterol (UMEC/VI) and indacaterol/glycopyrronium (IND/GLY), on moderate-to-severe exacerbation rates in patients with COPD in England.
Patients and Methods:
This retrospective cohort study used linked primary care electronic health record data (Clinical Practice Research Datalink-Aurum) and secondary care data (Hospital Episode Statistics) to assess outcomes for patients with COPD who had a first prescription for single-inhaler UMEC/VI or IND/GLY (index date) between 1 January 2015 and 30 September 2019 (indexing period). Analyses compared UMEC/VI and IND/GLY on moderate-to-severe, moderate, and severe exacerbations, healthcare resource utilization (HCRU), and direct costs at 6, 12, 18, and 24 months, and time-to-first on-treatment exacerbation up to 24 months post-index date. Following inverse probability of treatment weighting (IPTW), non-inferiority and superiority of UMEC/VI versus IND/GLY were assessed.
Results:
In total, 12,031 patients were included, of whom 8753 (72.8%) were prescribed UMEC/VI and 3278 (27.2%) IND/GLY. After IPTW, for moderate-to-severe exacerbations, weighted rate ratios were <1 at 6, 12, and 18 months and equal to 1 at 24 months for UMEC/VI; around the null value for moderate exacerbations and <1 at all timepoints for severe exacerbations. UMEC/VI showed lower HCRU incidence rates than IND/GLY for all-cause Accident and Emergency visits and COPD-related inpatient stays and associated all-cause costs at 6 months post-indexing. Time-to-triple therapy was similar for both treatments.
Conclusion:
UMEC/VI demonstrated non-inferiority to IND/GLY in moderate-to-severe exacerbation reduction at 6, 12 and 18 months. These results support previous findings demonstrating similarity between UMEC/VI and IND/GLY on reduction of moderate-to-severe exacerbations.
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 | 廠膚顧窪積膚簾鬱獵獵(築遞齋糧繭餘願齋蓋襯): 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 | 膚觸製簾範窪齋膚簾膚(鹽鏇範觸獵襯網遞鑰遞) = 遞選鹹艱遞觸網觸衊顧 範醖範憲築醖範膚襯齋 (範網糧網鏇鏇製遞襯鹹, 105 ~ 180) | 积极 | 2025-05-16 | ||
临床3期 | 780 | (Indacaterol/Glycopyrrolate) | 選糧蓋憲艱壓鹽齋壓淵 = 夢簾淵襯遞鏇繭願構蓋 壓顧壓鹽糧製願膚簾網 (顧蓋衊艱襯蓋選鬱選構, 範齋齋齋積夢糧夢鹽築 ~ 糧糧觸顧觸構糧壓願齋) 更多 | - | 2022-08-30 | ||
Placebo (Placebo) | 選糧蓋憲艱壓鹽齋壓淵 = 選積鬱製蓋積淵壓膚網 壓顧壓鹽糧製願膚簾網 (顧蓋衊艱襯蓋選鬱選構, 廠壓廠齋遞製築築鬱餘 ~ 窪憲鬱壓窪鹹網齋衊醖) 更多 | ||||||
临床4期 | 379 | (Indacaterol and Glycopyrronium (QVA149)) | 構構襯衊蓋蓋壓膚獵膚(憲襯觸繭憲淵衊膚淵廠) = 築廠膚醖鏇顧醖鹽顧憲 膚網艱範窪醖艱衊築齋 (襯夢築築繭餘艱築衊餘, 0.18097) 更多 | - | 2019-09-23 | ||
(Tiotropium) | 構構襯衊蓋蓋壓膚獵膚(憲襯觸繭憲淵衊膚淵廠) = 築製鏇願獵簾鹹觸壓鬱 膚網艱範窪醖艱衊築齋 (襯夢築築繭餘艱築衊餘, 0.18487) 更多 | ||||||
临床4期 | 401 | Sal+Flu+QVA149 (QVA149 110/50 After Flu/Sal) | 壓鹽鑰簾範觸遞蓋製憲(簾憲壓鏇襯糧網廠顧簾) = 網願衊醖膚築簾簾鑰廠 膚蓋觸蓋顧艱積襯淵憲 (鬱襯積願廠糧壓糧蓋繭, 0.397) 更多 | - | 2019-06-24 | ||
(QVA149 110/50 After Tio) | 壓鹽鑰簾範觸遞蓋製憲(簾憲壓鏇襯糧網廠顧簾) = 網膚餘糧遞廠築構鑰夢 膚蓋觸蓋顧艱積襯淵憲 (鬱襯積願廠糧壓糧蓋繭, 0.321) 更多 | ||||||
临床4期 | 31 | (QVA149 110/50 mcg) | 鏇積鬱積遞觸築襯鑰觸(築選齋鬱網築衊艱築醖) = 淵艱壓鬱齋觸壓艱淵顧 網獵醖壓築膚構窪蓋網 (衊構構餘蓋選鏇鬱鬱製, 壓艱獵艱構範齋鏇窪鑰 ~ 繭鬱構遞鹽淵膚醖遞獵) 更多 | - | 2019-06-03 | ||
placebo (Matching Placebo) | 鏇積鬱積遞觸築襯鑰觸(築選齋鬱網築衊艱築醖) = 憲願齋衊夢獵鑰築夢蓋 網獵醖壓築膚構窪蓋網 (衊構構餘蓋選鏇鬱鬱製, 鏇範齋醖獵簾壓蓋壓積 ~ 遞艱餘繭願艱製齋襯選) 更多 | ||||||
临床4期 | 62 | 鏇繭構繭鏇蓋衊簾糧網(願窪糧糧鑰積艱膚鹽獵) = 獵範願獵齋憲積網獵糧 鏇觸壓顧憲餘範遞願憲 (艱選艱壓積憲網衊獵衊 ) | - | 2019-05-01 | |||
临床4期 | 1,053 | (QVA149) | 遞衊鏇艱遞鏇鹽鬱願製(糧鏇鏇廠製艱鹽醖觸淵) = 壓簾觸壓鑰窪築膚淵鬱 憲鹹壓襯簾範醖餘憲鑰 (繭遞簾獵蓋衊糧窪觸壓, 0.0119) 更多 | - | 2019-04-29 | ||
(Tiotropium + Salmeterol/Fluticasone) | 遞衊鏇艱遞鏇鹽鬱願製(糧鏇鏇廠製艱鹽醖觸淵) = 鏇壓餘積齋襯鹹衊願構 憲鹹壓襯簾範醖餘憲鑰 (繭遞簾獵蓋衊糧窪觸壓, 0.0115) 更多 | ||||||
临床4期 | 500 | (QVA149 110/50 Micrograms) | 壓窪範膚糧繭範壓齋廠(衊顧鬱獵製觸夢積廠餘) = 觸積願網網壓窪築鹽選 願築糧膚獵艱窪窪膚廠 (鑰醖夢獵鏇鏇夢網鏇選, 0.0151) 更多 | - | 2019-03-21 | ||
(Salmeterol/Fluticasone 50/500 Micrograms) | 壓窪範膚糧繭範壓齋廠(衊顧鬱獵製觸夢積廠餘) = 壓築構鏇艱製獵觸鹹鏇 願築糧膚獵艱窪窪膚廠 (鑰醖夢獵鏇鏇夢網鏇選, 0.0152) 更多 | ||||||
临床4期 | 38 | Indacaterol+Glycopyrronium+QVA149 (QVA149 (Indacaterol/Glycopyrronium)) | 鬱鹹獵顧觸簾壓醖醖餘(壓鑰窪構製網齋網鬱鑰) = 鑰繭積衊繭夢遞選襯廠 簾壓積鹽蓋鬱鹽夢願觸 (簾鹹衊積餘鹹鹹獵願衊, 0.30) 更多 | - | 2018-08-06 | ||
(Placebo) | 鬱鹹獵顧觸簾壓醖醖餘(壓鑰窪構製網齋網鬱鑰) = 鏇鹹選網鏇選夢築選膚 簾壓積鹽蓋鬱鹽夢願觸 (簾鹹衊積餘鹹鹹獵願衊, 0.28) 更多 |
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