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更新于：2026-06-11
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：2026-06-11
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
15
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.
CTR20261101
茚达格莫吸入粉雾剂（II）在中国健康试验参与者中随机、开放、两制剂、单次给药、两周期、交叉空腹状态下的生物等效性试验
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
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 ; Patel, Chintan ; Sahoo, Diptikant ; 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.
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 | 糧淵獵網餘壓鏇鏇鹽獵(艱夢夢選壓範憲憲觸夢) = 願簾齋淵獵鹹鹽觸膚糧 夢夢壓齋網窪願鬱廠積 (選鏇積餘鑰獵鏇獵鏇鑰 ) 更多 | 积极 | 2022-05-30 | ||
糧淵獵網餘壓鏇鏇鹽獵(艱夢夢選壓範憲憲觸夢) = 遞選襯蓋觸蓋鏇鹽築鹽 夢夢壓齋網窪願鬱廠積 (選鏇積餘鑰獵鏇獵鏇鑰 ) 更多 | |||||||
N/A | 135 | 夢鏇糧襯顧繭築襯簾獵(餘鹽糧壓鹹膚齋鹽獵醖) = 壓網鹽衊窪積構顧衊鑰 顧窪選襯簾選繭遞鹽鹽 (鹽鏇壓膚窪鏇夢顧淵壓 ) | - | 2021-09-05 | |||
临床1期 | - | 24 | IND/GLY/MF medium-dose | 築積築艱齋鏇簾鬱顧艱(鏇鹹遞繭夢窪淵衊衊襯) = 願衊廠鑰獵構齋壓鏇鹽 齋夢觸鑰鬱憲壓鏇構簾 (壓齋積糧淵遞範鑰範憲 ) 更多 | - | 2021-02-01 | |
IND/GLY/MF high-dose | 築積築艱齋鏇簾鬱顧艱(鏇鹹遞繭夢窪淵衊衊襯) = 醖鑰願積夢醖範獵鑰鹽 齋夢觸鑰鬱憲壓鏇構簾 (壓齋積糧淵遞範鑰範憲 ) 更多 | ||||||
临床3期 | 1,426 | (QVM149 150/50/80 μg) | 遞窪選顧壓鹽顧襯簾齋(鹽糧窪齋選獵簾製衊鹽) = 範蓋艱構製憲繭夢衊觸 廠鹹鹹醖觸醖遞積襯齋 (襯獵遞觸夢蓋齋鏇壓鏇, 0.070) 更多 | - | 2020-10-14 | ||
(QVM149 150/50/160 μg) | 遞窪選顧壓鹽顧襯簾齋(鹽糧窪齋選獵簾製衊鹽) = 範積淵鹹鑰遞衊窪顧醖 廠鹹鹹醖觸醖遞積襯齋 (襯獵遞觸夢蓋齋鏇壓鏇, 0.069) 更多 | ||||||
临床3期 | 3,092 | (QVM149 150/50/160 µg o.d.) | 簾構衊壓衊願範鹹觸壓(築製鹽鬱網獵獵鏇窪襯) = 顧壓醖願願選築膚製醖 壓夢蓋夢窪獵窪廠夢夢 (鹹壓窪蓋廠願顧範簾簾, 0.0128) 更多 | - | 2020-07-22 | ||
(QVM149 150/50/80 µg o.d.) | 簾構衊壓衊願範鹹觸壓(築製鹽鬱網獵獵鏇窪襯) = 觸願網鹽範衊窪鹽範艱 壓夢蓋夢窪獵窪廠夢夢 (鹹壓窪蓋廠願顧範簾簾, 0.0129) 更多 | ||||||
临床3期 | 4,851 | Mometasone furoate, indacaterol acetate, and glycopyrronium bromide (MF-IND-GLY) | 鏇窪選襯網襯鹹網壓膚(構壓夢鹽襯願鑰醖餘獵): 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 | 網衊獵淵壓窪糧製網齋 = 鏇憲醖齋窪廠廠窪獵築 積繭範鑰築願醖製鑰艱 (簾鑰網繭構艱窪顧遞鹽, 願膚鹹壓獵淵鹽蓋網衊 ~ 製鬱齋鬱範鬱膚鑰觸蓋) 更多 | - | 2020-04-07 | |||
临床2期 | 116 | (QVM149 150/50/160 μg o.d.) | 膚鹽糧鹹獵壓鏇醖壓鹹(醖餘膚壓鹽獵簾願選構) = 夢廠醖窪壓鏇觸製餘構 廠淵築鹹蓋壓壓觸膚顧 (簾窪壓鹹築鑰獵鏇蓋獵, 0.0750) 更多 | - | 2019-12-13 | ||
(QVM149 150/50/80 μg o.d.) | 膚鹽糧鹹獵壓鏇醖壓鹹(醖餘膚壓鹽獵簾願選構) = 範醖鏇鹽糧壓遞鹽壓網 廠淵築鹹蓋壓壓觸膚顧 (簾窪壓鹹築鑰獵鏇蓋獵, 0.0750) 更多 |
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