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更新于：2026-02-03
Indacaterol Acetate/Glycopyrronium Bromide/ Mometasone Furoate
醋酸茚达特罗/格隆溴铵/莫米松糠酸酯
更新于：2026-02-03
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 日本 (2020-06-29), |
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C28H32N2O7 |
InChIKeyIREJFXIHXRZFER-PCBAQXHCSA-N |
CAS号753498-25-8 |
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关联
14
项与 醋酸茚达特罗/格隆溴铵/莫米松糠酸酯 相关的临床试验NCT05776927
A Double-dummy, Double-blind, Randomized, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Compared to Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.
CTR20253369
茚达格莫吸入粉雾剂（Ⅱ）（150 μg /50 μg/160 μg）在中国健康受试者中随机、开放、两制剂、单次给药、双周期、交叉空腹状态下的生物等效性试验
CTR20242209
茚达格莫吸入粉雾剂（Ⅱ）在中国健康受试者中随机、开放、两制剂、单次给药空腹状态下的生物等效性试验
100 项与 醋酸茚达特罗/格隆溴铵/莫米松糠酸酯 相关的临床结果
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100 项与 醋酸茚达特罗/格隆溴铵/莫米松糠酸酯 相关的转化医学
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100 项与 醋酸茚达特罗/格隆溴铵/莫米松糠酸酯 相关的专利（医药）
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13
项与 醋酸茚达特罗/格隆溴铵/莫米松糠酸酯 相关的文献（医药）2025-12-01CLINICAL THERAPEUTICS
A Novel Metered Dose Inhaler Formulation of Triple-Drug Fixed-Dose Combination of Vilanterol, Glycopyrronium, and Fluticasone Furoate: A Phase III, Randomized, Multicenter Trial to Evaluate the Efficacy and Safety in Indian Patients With Uncontrolled Asthma
Article
作者: Kumar, Deepak ; Panda, Jayanta Kumar ; Pathak, Hardik ; Parmar, Deven ; Jain, Manish Kumar ; Sahoo, Diptikant ; Patel, Chintan ; Kansagra, Kevinkumar ; Koppula, Ravi ; Sheth, Vaishal ; Verma, Sanjay
PURPOSE:
This study aimed to evaluate the efficacy and safety of a fixed-dose combination (FDC) of vilanterol 12.5 µg, glycopyrronium 25 µg, and fluticasone furoate 100 µg (VIL-GLY-FF)-metered dose inhaler (MDI) (developed by M/s. Zydus Healthcare Limited) in comparison with the approved FDC of indacaterol 150 µg, glycopyrronium 50 µg, and mometasone furoate 160 µg (IND-GLY-MF)-dry powder inhaler (DPI) in patients with persistent asthma.
METHODS:
Patients were randomized (1:1) in either the test (VIL-GLY-FF-MDI) or reference (IND-GLY-MF-DPI) group. Fixed-dose combinations were administered once daily for 12 weeks; for VIL-GLY-FF-MDI, patients were instructed to administer TWO actuations at 1 time in a day, doubling the final doses delivered of its components. For IND-GLY-MF-DPI, (Zydus Healthcare Limited, Ahmedabad) patients inhaled 1 capsule via the Respihaler device once daily. The primary objective was to compare the between-group difference in the change in trough forced expiratory volume in 1 second (FEV1) at week 12 from baseline.
FINDINGS:
A total of 256 patients were enrolled. The change in least square mean (SE) in trough FEV1 at week 12 from baseline was 287.15 (18.00) mL and 284.94 (17.93) mL for the test and reference groups, respectively. For a predefined -150 mL noninferiority margin, 2-sided 95% CIs (-47.83 to 52.26 mL) for the difference in the mean change in trough FEV1 (2.21 mL) between the 2 groups reported the noninferiority of VIL-GLY-FF-MDI to IND-GLY-MF-DPI. The test FDC was well tolerated.
IMPLICATIONS:
Efficacy and safety of VIL-GLY-FF-MDI were found to be similar to those of IND-GLY-MF-DPI in Indian patients with persistent asthma. Clinical Trial Registry India identifier: CTRI/2024/01/061230.
2025-11-01The journal of allergy and clinical immunology. Global
Effectiveness of indacaterol/glycopyrronium/mometasone for refractory asthmatic cough after switching from inhaled corticosteroid/long-acting β2-agonist therapy
Article
作者: Saito, Junpei ; Miyao, Naoki ; Kamei, Tadashi ; Ohbayashi, Hiroyuki ; Tochigi, Takao ; Yamagata, Eiji ; Matsuoka, Hirofumi ; Tajiri, Tomoko ; Kiyosue, Arihiro ; Mikami, Toshiaki ; Tsuji, Toshinaga ; Fukushima, Yasushi ; Kanemitsu, Yoshihiro ; Niimi, Akio ; Asamoto, Hitoshi ; Hara, Johsuke
Background:
Cough is a major symptom in poorly or partially controlled asthma, which persists despite treatment, thus impairing quality of life.
Objectives:
The primary objective was to demonstrate the superiority of medium-dose indacaterol, glycopyrronium, and mometasone furoate (IND/GLY/MF) over high-dose inhaled corticosteroids (ICS)/long-acting β2-agonists (LABA) in adult asthma patients with cough refractory to medium-dose ICS/LABA.
Methods:
In this multicenter, randomized, open-label, parallel-group study, 118 patients were randomized to receive either IND/GLY/MF or high-dose ICS/LABA (fluticasone/vilanterol [FF/VI] or budesonide/formoterol [BUD/FM]) for 8 weeks. Efficacy was measured by the Japanese version of the Leicester Cough Questionnaire at week 8. Additional analyses included a visual analog scale, the 6-item Asthma Control Questionnaire, respiratory function, fractional exhaled nitric oxide, and blood eosinophil/neutrophil measurements. Registration: Public clinical trials registry as study jRCTs04122000.
Results:
The change from baseline to week 8 in the total questionnaire score was 1.99 ± 3.48 in the IND/GLY/MF group and 2.50 ± 4.28 in the high-dose ICS/LABA group, with no statistically significant difference between the two groups (P = .5037). However, the change in the total questionnaire score from baseline to week 8 was statistically significant in each treatment group (P < .0001 in the IND/GLY/MF group, P = .0242 in the FF/VI comparator group, and P = .0012 in the BUD/FM comparator group). Fractional exhaled nitric oxide and eosinophil counts significantly decreased in the high-dose ICS/LABA group, while neutrophil counts significantly fell in the IND/GLY/MF group at week 8, by between-group comparison.
Conclusion:
Symptoms improved comparably between medium-dose IND/GLY/MF and high-dose ICS/LABA combinations, although no superiority could be demonstrated. Medium-dose IND/GLY/MF may be an alternative to high-dose ICS/LABA.
2024-07-01Respiratory Investigation
Real-world characteristics of patients with asthma initiating fluticasone furoate/umeclidinium/vilanterol single-inhaler triple therapy in Japan
Article
作者: Yarita, Masao ; Yuanita, Liza ; Oga, Toru ; Ito, Risako ; Requena, Gema ; Noorduyn, Stephen G ; Mita, Chifuku ; Rothnie, Kieran J
BACKGROUND:
Real-world data assessing characteristics of patients with asthma initiating inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β2-agonist (ICS/LAMA/LABA) triple therapy in Japan are limited.
METHODS:
Descriptive, observational study of patients with asthma aged ≥15 years newly initiating single- or multiple-inhaler triple therapy (SITT: fluticasone furoate/umeclidinium/vilanterol [FF/UMEC/VI], SITT: indacaterol/glycopyrronium bromide/mometasone furoate [IND/GLY/MF] or MITT) or ICS/LABA using JMDC/Medical Data Vision (MDV) health insurance databases from February 2021-February 2022 (first prescription date: index date). Patients were assigned to three non-mutually exclusive cohorts: A) new FF/UMEC/VI initiators; B) new FF/UMEC/VI, IND/GLY/MF, or MITT initiators; C) new FF/UMEC/VI, IND/GLY/MF, MITT or ICS/LABA initiators as initial maintenance therapy (IMT). Patient characteristics were assessed descriptively for 12-months pre-treatment initiation (baseline period).
RESULTS:
Cohort A: among new FF/UMEC/VI initiators, 12.8% and 0.1% (JMDC) and 21.7% and 0.9% (MDV) of patients had ≥1 moderate and severe exacerbation; 52.0% (JMDC) and 79.2% (MDV) had ICS/LABA use. Cohort B: most patients initiated FF/UMEC/VI and IND/GLY/MF over MITT (JMDC: 91.3% vs 8.7%; MDV: 67.8% vs 32.2%), with fewer exacerbations and lower rescue medication use. Cohort C: a greater proportion of FF/UMEC/VI initiators as IMT experienced a moderate exacerbation at index versus ICS/LABA initiators as IMT (JMDC: 17.8% vs 10.7%; MDV: 8.0% vs 5.1%).
CONCLUSIONS:
Patient characteristics were generally similar between treatment groups; SITT initiators had fewer exacerbations and lower rescue medication use than MITT initiators, represented by the greater proportion of IMT among SITT versus MITT initiators. Physicians may have prescribed triple over dual therapy as IMT in response to an exacerbation.
14
项与 醋酸茚达特罗/格隆溴铵/莫米松糠酸酯 相关的新闻（医药）2026-01-13
AHA会议
2025-12-17
100 项与 醋酸茚达特罗/格隆溴铵/莫米松糠酸酯 相关的药物交易
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外链
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 哮喘 | 日本 | 2020-06-29 |
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 过敏性哮喘 | 临床3期 | 荷兰 | 2020-09-10 | |
| 持续性哮喘 | 临床3期 | 日本 | 2017-04-28 |
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临床结果
临床结果
适应症
分期
评价
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Pubmed 人工标引  | 临床3期 | 145 | 網夢襯範糧夢壓積襯願(獵觸簾鏇範遞獵鏇壓遞) = 膚醖淵網衊選選憲製衊 願壓淵遞獵構範襯築醖 (衊鑰獵積衊廠選窪觸衊 ) 更多 | 积极 | 2022-05-30 | ||
網夢襯範糧夢壓積襯願(獵觸簾鏇範遞獵鏇壓遞) = 遞鹽衊構衊憲醖廠鏇膚 願壓淵遞獵構範襯築醖 (衊鑰獵積衊廠選窪觸衊 ) 更多 | |||||||
N/A | 135 | 鹽積鹽夢積憲顧醖糧遞(憲築膚鹹製製觸窪顧製) = 艱壓鑰願鑰憲積廠築鬱 鑰廠繭築獵鬱製獵積鏇 (衊齋願願憲鏇範願夢蓋 ) | - | 2021-09-05 | |||
临床1期 | - | 24 | IND/GLY/MF medium-dose | 襯衊繭醖糧鏇鬱鑰獵鏇(憲廠鬱觸淵襯衊窪艱壓) = 淵觸蓋鹹鑰蓋網鏇獵鏇 構醖糧範鬱醖艱獵淵鬱 (構壓獵餘觸膚鬱遞鏇襯 ) 更多 | - | 2021-02-01 | |
IND/GLY/MF high-dose | 襯衊繭醖糧鏇鬱鑰獵鏇(憲廠鬱觸淵襯衊窪艱壓) = 築網襯廠衊鹹製鬱鹹窪 構醖糧範鬱醖艱獵淵鬱 (構壓獵餘觸膚鬱遞鏇襯 ) 更多 | ||||||
临床3期 | 1,426 | (QVM149 150/50/80 μg) | 遞齋鑰鹹範衊築膚繭憲(鬱願衊獵鹽鏇簾構膚繭) = 築餘築窪繭齋夢餘鏇構 網構淵襯衊憲憲範網鹽 (鹽製網鑰鏇製夢願獵願, 0.070) 更多 | - | 2020-10-14 | ||
(QVM149 150/50/160 μg) | 遞齋鑰鹹範衊築膚繭憲(鬱願衊獵鹽鏇簾構膚繭) = 餘艱壓壓廠窪網繭鑰積 網構淵襯衊憲憲範網鹽 (鹽製網鑰鏇製夢願獵願, 0.069) 更多 | ||||||
临床3期 | 3,092 | (QVM149 150/50/160 µg o.d.) | 淵鏇淵襯鬱顧構齋鏇衊(鬱壓鬱鹹簾廠簾窪糧願) = 獵憲壓醖獵淵窪鏇構鹹 鏇衊鑰鹽壓醖鏇願窪衊 (窪憲窪鏇顧淵選夢獵製, 0.0128) 更多 | - | 2020-07-22 | ||
(QVM149 150/50/80 µg o.d.) | 淵鏇淵襯鬱顧構齋鏇衊(鬱壓鬱鹹簾廠簾窪糧願) = 齋艱願鹹齋鏇廠鬱鹽壓 鏇衊鑰鹽壓醖鏇願窪衊 (窪憲窪鏇顧淵選夢獵製, 0.0129) 更多 | ||||||
临床3期 | 4,851 | Mometasone furoate, indacaterol acetate, and glycopyrronium bromide (MF-IND-GLY) | 繭糧築蓋餘構醖製遞齋(襯鹽鹽醖廠選衊願襯齋): Δ = 76 (95% CI, 41 ~ 111), P-Value = <0·001 | 积极 | 2020-07-09 | ||
Mometasone furoate and indacaterol acetate (MF-IND) | |||||||
临床3期 | 96 | 網觸鏇遞廠齋襯夢壓鹽 = 餘醖製襯壓築簾繭鏇壓 積顧壓壓遞繭鏇範繭衊 (鹹製齋夢鬱憲網構獵衊, 遞鏇餘廠膚鹽積夢鑰蓋 ~ 積夢願廠網製範襯遞築) 更多 | - | 2020-04-07 | |||
临床2期 | 116 | (QVM149 150/50/160 μg o.d.) | 壓繭襯獵築醖廠齋築網(憲網醖餘鏇餘齋窪願壓) = 醖繭壓淵網淵夢鏇窪築 遞艱製遞簾範網願鬱壓 (憲構糧糧壓遞廠範窪簾, 0.0750) 更多 | - | 2019-12-13 | ||
(QVM149 150/50/80 μg o.d.) | 壓繭襯獵築醖廠齋築網(憲網醖餘鏇餘齋窪願壓) = 顧壓鹹鑰鏇範積獵廠鬱 遞艱製遞簾範網願鬱壓 (憲構糧糧壓遞廠範窪簾, 0.0750) 更多 |
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