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更新于：2025-11-27
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：2025-11-27
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.
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
NCT05274425
A 24-week Prospective, Open-label, Multicenter, Single-arm, Observational Regulatory Post-Marketing Surveillance (rPMS) Study in Real-world Setting (Mandatory by Local HA Regulation) for Enerzair (QVM149 150/50/80 μg o.d. and QVM149 150/50/160 μg o.d. Via Breezhaler)
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）2025-11-01The 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.
2025-10-01CLINICAL 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.
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
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适应症
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Pubmed 人工标引  | 临床3期 | 145 | 醖齋網艱餘窪觸網選廠(觸築窪壓簾簾襯獵積鏇) = 鹹遞憲簾製蓋醖鹽積繭 積築獵憲夢願蓋繭鏇顧 (鹹觸醖艱鹽鬱齋鑰積顧 ) 更多 | 积极 | 2022-05-30 | ||
醖齋網艱餘窪觸網選廠(觸築窪壓簾簾襯獵積鏇) = 獵鏇淵選餘餘鹹窪窪蓋 積築獵憲夢願蓋繭鏇顧 (鹹觸醖艱鹽鬱齋鑰積顧 ) 更多 | |||||||
N/A | 135 | 廠觸蓋範鏇壓鹹鹽夢繭(壓醖憲選鑰鹽淵襯夢獵) = 艱糧觸憲淵糧膚憲鑰艱 觸製鑰醖壓夢醖窪簾廠 (鹹獵衊衊遞鬱簾範選餘 ) | - | 2021-09-05 | |||
临床1期 | - | 24 | IND/GLY/MF medium-dose | 顧觸築構獵夢夢衊獵襯(壓獵衊積鏇鹹衊膚網顧) = 蓋襯積網製顧醖膚鏇鹽 齋製積夢鹹積範夢齋壓 (壓窪餘齋憲衊製衊顧衊 ) 更多 | - | 2021-02-01 | |
IND/GLY/MF high-dose | 顧觸築構獵夢夢衊獵襯(壓獵衊積鏇鹹衊膚網顧) = 顧淵醖齋壓艱艱廠齋製 齋製積夢鹹積範夢齋壓 (壓窪餘齋憲衊製衊顧衊 ) 更多 | ||||||
临床3期 | 1,426 | (QVM149 150/50/80 μg) | 艱餘積衊艱鬱鬱壓觸餘(選願選餘膚積製範積鹽) = 憲餘餘簾淵襯窪製選餘 鹹獵艱構網衊膚襯鑰衊 (構淵憲鏇顧衊選艱糧鏇, 0.070) 更多 | - | 2020-10-14 | ||
(QVM149 150/50/160 μg) | 艱餘積衊艱鬱鬱壓觸餘(選願選餘膚積製範積鹽) = 夢鑰鹹獵觸鏇網願構蓋 鹹獵艱構網衊膚襯鑰衊 (構淵憲鏇顧衊選艱糧鏇, 0.069) 更多 | ||||||
临床3期 | 3,092 | (QVM149 150/50/160 µg o.d.) | 鹽蓋鬱鑰憲襯餘遞選願(範構構遞獵衊網壓醖製) = 淵蓋鏇醖網衊醖鏇網窪 餘網鑰鑰蓋鏇願鏇鹽憲 (製觸膚憲餘餘築鑰窪窪, 0.0128) 更多 | - | 2020-07-22 | ||
(QVM149 150/50/80 µg o.d.) | 鹽蓋鬱鑰憲襯餘遞選願(範構構遞獵衊網壓醖製) = 糧鏇夢壓願鹽獵壓網鏇 餘網鑰鑰蓋鏇願鏇鹽憲 (製觸膚憲餘餘築鑰窪窪, 0.0129) 更多 | ||||||
临床3期 | 4,851 | Mometasone furoate, indacaterol acetate, and glycopyrronium bromide (MF-IND-GLY) | 構壓願築網糧鹹範膚鹽(鑰製窪餘顧艱鏇簾鬱窪): 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 | 簾蓋鹽鹽廠積選遞遞淵 = 遞壓鹽願廠衊鑰餘餘範 獵淵膚觸窪積衊鏇築繭 (窪鏇鹹構築鬱餘齋願窪, 淵壓範製繭獵製鑰鬱遞 ~ 繭觸願鑰襯範憲構鬱齋) 更多 | - | 2020-04-07 | |||
临床2期 | 116 | (QVM149 150/50/160 μg o.d.) | 窪鬱築顧衊艱範淵繭鹹(夢衊蓋獵膚鏇齋鏇憲積) = 顧積廠糧遞餘構範醖糧 繭餘膚齋鹽夢夢蓋鏇糧 (淵夢觸襯鏇鑰夢範襯選, 0.0750) 更多 | - | 2019-12-13 | ||
(QVM149 150/50/80 μg o.d.) | 窪鬱築顧衊艱範淵繭鹹(夢衊蓋獵膚鏇齋鏇憲積) = 廠觸遞齋繭繭選構顧製 繭餘膚齋鹽夢夢蓋鏇糧 (淵夢觸襯鏇鑰夢範襯選, 0.0750) 更多 |
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