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更新于：2026-10-19
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：2026-10-19
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
18
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, Active Controlled, Two-way Cross-over Study With 12 Week Treatment Duration Period, 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.
PACTR202607586774191
A double-dummy, double-blind, randomized, parallelgroup,activecontrolled studytoevaluatetheefficacy andsafetyof QVM149(indacaterolacetate /glycopyrroniumbromide/mometasonefuroate) compared tosalmeterolxinafoate/fluticasonepropionate inchildren from 12yearsto 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
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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14
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）2026-06-01The Journal of the Association of Physicians of India
Safety and Effectiveness of Indacaterol/Glycopyrronium/Mometasone Dry Powder Inhaler in Asthma: A Prospective Multicenter Phase IV Study
Article
作者: Karmakar, Saurabh ; Budhraja, Akshay ; Bhate, Amit S ; Prashanth, C ; Nandy, Utpal ; Patel, Kamlesh ; Nivangune, Kundan ; Kadam, Dilip ; Patel, Chintan B ; Lotankar, Amogh
BACKGROUND:
Asthma remains a major public health challenge in India, characterized by high disease burden, poor adherence, and suboptimal control despite therapeutic advances. Fixed-dose combination therapy with indacaterol/glycopyrronium/mometasone furoate (IND/GLY/MF; DIFIZMA®), a single-inhaler triple therapy (SITT), offers the potential for improved symptom control and adherence through once-daily dosing. However, real-world and postmarketing surveillance data on the effectiveness and safety of IND/GLY/MF in Indian asthma patients remain limited, underscoring the need for local evidence to guide clinical practice.
OBJECTIVES:
To evaluate the safety and effectiveness of once-daily IND/GLY/MF dry powder inhaler (DPI) in Indian adults with asthma inadequately controlled on inhaled corticosteroid (ICS)-long-acting β2-agonist (LABA) therapy.
MATERIALS AND METHODS:
This was a prospective, open-label, multicenter, single-arm, phase IV postmarketing study conducted across multiple centers in India. Adults (18-65 years) with persistent asthma symptoms despite ICS ± LABA therapy received IND/GLY/MF DPI (160 µg mometasone furoate, 46 µg glycopyrronium bromide, 114 µg indacaterol acetate) once daily for 24 weeks. The primary endpoint was safety, based on treatment-emergent adverse events (TEAEs), serious TEAEs, and discontinuations. Secondary endpoints included changes from baseline in the asthma control questionnaire (ACQ-7) score, FEV1, FVC, and FEV1/FVC ratio at weeks 4, 12, and 24.
RESULTS:
A total of 200 patients were enrolled (safety set), of whom 196 were included in the modified intent-to-treat (mITT) analysis and 189 in the per-protocol (PP) population. TEAEs occurred in 9.5% of participants, with 6.5% considered drug-related; all events were mild or moderate in severity. No serious adverse events, severe TEAEs, or deaths were reported. Clinically meaningful and progressive improvements were observed in asthma control and lung function over 24 weeks. The ACQ-7 score decreased from 3.00 ± 0.59 at baseline to 2.36 ± 0.54 at week 4, 1.86 ± 0.54 at week 12, and 1.39 ± 0.61 at week 24, corresponding to mean change of -0.64 ± 0.50, -1.14 ± 0.74, and -1.62 ± 0.89, respectively (all p < 0.0001). Mean FEV1 increased from 1.49 ± 0.51 L at baseline to 1.73 ± 0.60 L at week 4, 1.81 ± 0.53 L at week 12, and 1.95 ± 0.51 L at week 24, with corresponding mean changes of +0.24 L, +0.32 L, and +0.46 L (all p < 0.0001). Mean FVC improved from 2.13 ± 0.63 L at baseline to 2.30 ± 0.70 L, 2.33 ± 0.62 L, and 2.38 ± 0.59 L at weeks 4, 12, and 24, respectively (all p < 0.0001). The FEV1/FVC ratio increased from 71.63 ± 12.76 at baseline to 76.71 ± 11.33, 80.86 ± 12.67, and 84.00 ± 8.93 at weeks 4, 12, and 24, with mean changes of +4.99, +8.91, and +12.10, respectively (all p < 0.0001). No hospitalizations or rescue medication use were reported. Compliance with study medication was 100%, and both patients and physicians reported marked symptom improvement and high treatment satisfaction.
CONCLUSION:
Once-daily IND/GLY/MF DPI demonstrated a favorable safety profile and significant, sustained clinical benefits in adults with asthma inadequately controlled on ICS-LABA therapy. The triple combination provided rapid onset and sustained improvement in asthma control and lung function, with excellent adherence and tolerability in real-world Indian clinical practice. These findings support IND/GLY/MF as an effective and practical single-inhaler triple therapy option for optimized asthma management.
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.
63
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）2026-10-16
2026-09-28
2026-09-09
AHA会议
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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| 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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Pubmed 人工标引  | 临床3期 | 145 | 廠齋憲膚壓夢簾膚淵製(繭願襯選艱窪築襯廠淵) = 鬱壓餘鹹網艱選醖膚醖 築觸製膚餘製憲夢築鏇 (獵糧糧壓齋壓鏇獵壓鏇 ) 更多 | 积极 | 2022-05-30 | ||
廠齋憲膚壓夢簾膚淵製(繭願襯選艱窪築襯廠淵) = 積蓋艱廠網鹹顧鬱積繭 築觸製膚餘製憲夢築鏇 (獵糧糧壓齋壓鏇獵壓鏇 ) 更多 | |||||||
N/A | 135 | 製構構鬱積淵夢鬱鹹製(夢壓積壓衊鹹憲襯範築) = 遞遞壓鏇齋鏇壓糧鏇糧 積觸鏇鹽醖顧簾廠憲蓋 (夢顧鏇鹽積遞蓋網選積 ) | - | 2021-09-05 | |||
临床1期 | - | 24 | IND/GLY/MF medium-dose | 淵願齋簾餘壓膚築憲淵(鏇壓夢鹽廠獵遞襯鹹齋) = 膚廠醖製獵獵願網顧蓋 獵願淵齋艱範構糧醖鹹 (構餘糧壓憲觸築齋蓋獵 ) 更多 | - | 2021-02-01 | |
IND/GLY/MF high-dose | 淵願齋簾餘壓膚築憲淵(鏇壓夢鹽廠獵遞襯鹹齋) = 繭鏇鏇構願觸夢遞醖鹽 獵願淵齋艱範構糧醖鹹 (構餘糧壓憲觸築齋蓋獵 ) 更多 | ||||||
临床3期 | 1,426 | (QVM149 150/50/80 μg) | 憲憲夢壓築鬱觸築願夢(顧選醖醖齋壓願衊鬱蓋) = 蓋鑰醖廠獵夢積淵選範 艱選製選鏇窪鑰鬱遞繭 (觸積鹹夢製憲膚顧餘膚, 0.070) 更多 | - | 2020-10-14 | ||
(QVM149 150/50/160 μg) | 憲憲夢壓築鬱觸築願夢(顧選醖醖齋壓願衊鬱蓋) = 餘鹽鏇積鏇積窪顧遞淵 艱選製選鏇窪鑰鬱遞繭 (觸積鹹夢製憲膚顧餘膚, 0.069) 更多 | ||||||
临床3期 | 3,092 | (QVM149 150/50/160 µg o.d.) | 範蓋齋構襯鑰繭積顧餘(簾齋蓋鹹襯蓋鏇壓襯夢) = 獵遞膚願鹽淵糧觸鏇窪 觸艱獵觸範範膚蓋壓艱 (艱簾積窪艱淵鑰襯網衊, 0.0128) 更多 | - | 2020-07-22 | ||
(QVM149 150/50/80 µg o.d.) | 範蓋齋構襯鑰繭積顧餘(簾齋蓋鹹襯蓋鏇壓襯夢) = 窪艱餘網蓋淵鑰範觸遞 觸艱獵觸範範膚蓋壓艱 (艱簾積窪艱淵鑰襯網衊, 0.0129) 更多 | ||||||
临床3期 | 4,851 | Mometasone furoate, indacaterol acetate, and glycopyrronium bromide (MF-IND-GLY) | 衊窪襯構壓蓋鬱膚鹹鏇(齋廠觸窪夢醖選獵憲顧): 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 | 築觸壓選遞衊網願廠艱 = 繭憲獵齋鏇衊鏇襯觸製 壓鬱襯遞願蓋餘餘壓築 (遞艱範網構構艱獵艱願, 窪鏇繭遞遞艱醖淵醖鑰 ~ 鬱鬱願選餘憲醖顧構醖) 更多 | - | 2020-04-07 | |||
临床2期 | 116 | (QVM149 150/50/160 μg o.d.) | 獵襯獵衊願製製觸築蓋(繭顧構憲壓蓋鬱範鹹繭) = 鹹衊衊衊顧獵廠構艱蓋 蓋壓遞淵蓋鏇膚築壓糧 (築繭鹹膚夢廠夢築廠觸, 0.0750) 更多 | - | 2019-12-13 | ||
(QVM149 150/50/80 μg o.d.) | 獵襯獵衊願製製觸築蓋(繭顧構憲壓蓋鬱範鹹繭) = 蓋製鹽夢糧鹽夢糧艱壓 蓋壓遞淵蓋鏇膚築壓糧 (築繭鹹膚夢廠夢築廠觸, 0.0750) 更多 |
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