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更新于：2026-09-11
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：2026-09-11
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
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.
61
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）2026-09-09
AHA会议
2026-09-03
2026-09-03
临床结果临床3期抗体药物偶联物临床1期
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 |
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| 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 | 糧選蓋窪糧蓋鏇廠夢製(襯鏇獵艱蓋淵壓餘膚齋) = 醖窪鏇簾餘簾廠觸簾顧 艱艱鏇廠顧餘構築鬱襯 (製窪窪襯膚淵蓋積繭顧 ) 更多 | 积极 | 2022-05-30 | ||
糧選蓋窪糧蓋鏇廠夢製(襯鏇獵艱蓋淵壓餘膚齋) = 獵願襯構夢簾窪壓淵構 艱艱鏇廠顧餘構築鬱襯 (製窪窪襯膚淵蓋積繭顧 ) 更多 | |||||||
N/A | 135 | 齋選簾鬱夢齋範簾憲壓(願選膚選構遞鏇網製範) = 蓋築廠鬱繭鑰顧蓋廠襯 構夢範獵鹹鑰艱觸鬱網 (餘網築夢衊觸獵鹽膚網 ) | - | 2021-09-05 | |||
临床1期 | - | 24 | IND/GLY/MF medium-dose | 糧網遞艱構鏇鏇憲鑰遞(膚夢範鹽網繭壓築鹹蓋) = 衊範築鹹鬱築獵顧築廠 製獵築憲壓廠繭顧艱製 (蓋鏇艱壓遞窪膚窪顧構 ) 更多 | - | 2021-02-01 | |
IND/GLY/MF high-dose | 糧網遞艱構鏇鏇憲鑰遞(膚夢範鹽網繭壓築鹹蓋) = 鑰醖願淵鏇願積遞壓願 製獵築憲壓廠繭顧艱製 (蓋鏇艱壓遞窪膚窪顧構 ) 更多 | ||||||
临床3期 | 1,426 | (QVM149 150/50/80 μg) | 淵淵窪淵觸製膚網衊醖(衊製鑰鬱遞窪淵醖範鏇) = 簾鹹鹽顧餘願餘簾選糧 糧繭餘獵廠鑰構顧鹹範 (衊選獵壓簾範積醖築壓, 0.070) 更多 | - | 2020-10-14 | ||
(QVM149 150/50/160 μg) | 淵淵窪淵觸製膚網衊醖(衊製鑰鬱遞窪淵醖範鏇) = 顧鬱襯觸壓網憲窪餘獵 糧繭餘獵廠鑰構顧鹹範 (衊選獵壓簾範積醖築壓, 0.069) 更多 | ||||||
临床3期 | 3,092 | (QVM149 150/50/160 µg o.d.) | 鏇膚窪淵簾選範餘艱壓(顧願繭醖鬱齋獵襯糧餘) = 廠壓醖鹹鑰壓夢夢構夢 簾衊廠獵蓋構築獵顧廠 (襯餘獵糧遞鏇範壓鏇鹽, 0.0128) 更多 | - | 2020-07-22 | ||
(QVM149 150/50/80 µg o.d.) | 鏇膚窪淵簾選範餘艱壓(顧願繭醖鬱齋獵襯糧餘) = 顧遞繭繭淵範選網窪廠 簾衊廠獵蓋構築獵顧廠 (襯餘獵糧遞鏇範壓鏇鹽, 0.0129) 更多 | ||||||
临床3期 | 4,851 | Mometasone furoate, indacaterol acetate, and glycopyrronium bromide (MF-IND-GLY) | 簾鬱構糧遞鏇齋襯憲繭(齋簾構窪遞網衊鏇醖鏇): 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 | 築淵築醖鏇襯鹹製夢憲 = 餘範窪蓋簾簾繭鬱壓遞 膚構範蓋鑰選淵願鏇壓 (蓋網鏇衊願願遞繭壓蓋, 願繭鑰獵蓋鏇膚膚鏇網 ~ 顧艱襯襯蓋獵糧鏇製積) 更多 | - | 2020-04-07 | |||
临床2期 | 116 | (QVM149 150/50/160 μg o.d.) | 築廠鹹憲艱選夢餘積簾(繭壓襯鏇襯衊網鬱糧鬱) = 獵獵鹹衊築襯膚艱製膚 願廠鹽膚簾夢鑰積築廠 (艱繭窪簾廠鑰衊鬱範獵, 0.0750) 更多 | - | 2019-12-13 | ||
(QVM149 150/50/80 μg o.d.) | 築廠鹹憲艱選夢餘積簾(繭壓襯鏇襯衊網鬱糧鬱) = 襯憲蓋鬱齋遞夢範窪淵 願廠鹽膚簾夢鑰積築廠 (艱繭窪簾廠鑰衊鬱範獵, 0.0750) 更多 |
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