预约演示
更新于：2025-12-04
Tiotropium Bromide
噻托溴铵
更新于：2025-12-04
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 英国 (2002-04-02), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国) |
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结构/序列
分子式C19H24BrNO5S2 |
InChIKeyMQLXPRBEAHBZTK-SEINRUQRSA-M |
CAS号411207-31-3 |
关联
392
项与 噻托溴铵 相关的临床试验ChiCTR2500113245
A Multicenter, Randomized, Open-Label, Parallel-Group Study to Evaluate Early Intervention with Budesonide/Glycopyrronium/Formoterol Fumarate MDI in Patients with Mild and Moderate Chronic Obstructive Pulmonary Disease with Treatable Traits
CTR20254175
单中心、随机、开放、两周期、交叉设计评价中国健康试验参与者单次空腹经口吸入噻托溴铵吸入粉雾剂的人体生物等效性研究
CTRI/2025/05/087465
A Multicenter, Randomized, Assessor-Blind, Three period, Six-Sequence, Active- and Placebo- Controlled, Crossover, Single-Dose Study to Evaluatethe Bioequivalence (with Clinical Pharmacodynamic Endpoint) of Test Formulation Tiotropium Bromide Inhalation Powder 18 mcg/capsule with Reference Formulation Adult Patients with Chronic Obstructive Pulmonary Disease (COPD). - Nil
100 项与 噻托溴铵 相关的临床结果
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100 项与 噻托溴铵 相关的转化医学
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100 项与 噻托溴铵 相关的专利（医药）
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2,337
项与 噻托溴铵 相关的文献（医药）2025-11-01Respiratory Medicine and Research
Long-acting muscarinic antagonist versus leukotriene receptor antagonist as additional treatment in uncontrolled asthma patients used inhaled corticosteroids and long-acting β2 adrenergic agonist: a randomized phase 2 screening trial
Article
作者: Furuhashi, Kazuki ; Enomoto, Noriyuki ; Suzuki, Yuzo ; Fujisawa, Tomoyuki ; Niwa, Mitsuru ; Inoue, Yusuke ; Inui, Naoki ; Hasegawa, Hirotsugu ; Nihashi, Fumiya ; Toyoshima, Mikio ; Karayama, Masato ; Kaida, Yusuke ; Suda, Takafumi ; Shirai, Toshihiro ; Hozumi, Hironao ; Yasui, Hideki ; Mori, Kazutaka ; Ikeda, Masaki ; Koshimizu, Naoki ; Fujii, Masato
Bronchial asthma is a common disease treated primarily with inhaled corticosteroids (ICS) and long-acting beta-2 agonists (LABA), yet optimal add-on therapy with long-acting muscarinic antagonists (LAMA) or leukotriene receptor antagonists (LTRA) remains unclear. This multicenter, randomized, open-label phase 2 screening trial compared the efficacy of adding tiotropium (LAMA) versus montelukast (LTRA) to ICS/LABA therapy in adult patients with poorly controlled asthma. Patients were randomly assigned to receive either tiotropium or montelukast for 12 weeks. Primary outcome was the change in forced expiratory volume in 1 second (FEV1), secondary outcomes included changes in asthma control questionnaire (ACQ-5), asthma control test (ACT) scores, and peak expiratory flow (PEF). Ninety-four patients were analyzed. Over 12 weeks, the tiotropium group showed significant improvements in FEV1 and PEF, while the montelukast group showed no improvement in respiratory function. Both groups, however, showed significant improvements in ACQ-5 and ACT. The primary endpoint, change in FEV1 improved similarly in both groups (tiotropium 2.03 ± 0.74 to 2.10 ± 0.72 L vs montelukast 2.08 ± 0.69 to 2.13 ± 0.67 L; p = 0.736), while the tiotropium group exhibited a significantly greater improvement in PEF (tiotropium 5.41 ± 1.85 to 5.92 ± 1.93 L/s vs montelukast 5.58 ± 1.84 to 5.65 ± 1.82 L/s; p = 0.025). Subgroup analysis of patients with allergic rhinitis revealed the ACQ-5 score was significantly improved in the montelukast group (tiotropium 0.94 ± 0.64 to 0.68 ± 0.76 L/s vs montelukast 1.26 ± 1.15 to 0.53 ± 0.86 L/s; p = 0.002). Adding tiotropium to ICS/LABA therapy improves respiratory function, whereas adding montelukast enhances symptom control, particularly in patients with allergic rhinitis. These findings underscore the importance of personalized treatment approaches in asthma management by demonstrating that both tiotropium and montelukast confer distinct benefits according to patient characteristics, while also addressing a significant gap in the literature regarding optimal adjunctive therapies for adult asthma, given the scarcity of studies directly comparing these add-on strategies. Further research is needed to establish definitive guidelines for optimal add-on therapies in asthma.
2025-11-01CHEMICO-BIOLOGICAL INTERACTIONS
Identification of mechanisms underlying ventilatory dysfunction in organophosphorus chemical warfare agent-exposed mice
Article
作者: Penot, Mylène ; Taudon, Nicolas ; Hanak, Anne-Sophie ; Trancart, Marilène ; Meesemaecker, Gwladys ; Calas, André-Guilhem
Chemical warfare nerve agents (CWNA), such as VX, pose significant threats due to their profound impact on vital physiological systems. The primary concern is the risk of respiratory failure resulting from cholinergic dysregulation, a signaling pathway crucial for ventilatory function regulation. This study aims to elucidate the key mechanisms underlying the induction of respiratory failure in mice following sub-lethal VX exposure in order to optimize therapeutic management. We evaluated candidate compounds targeting cholinergic signaling pathways associated with the CWNA poisoning toxidrome or implicated in respiratory disorders with similar symptoms (e.g., asthma or opioid overdose). The efficacy of these compounds in preventing ventilatory abnormalities induced by subcutaneous exposure to 0.9 LD50 of VX was assessed using dual-chamber plethysmography, and survival tests were conducted to confirm their therapeutic effectiveness. Among all the pathways evaluated, only the muscarinic pathway appeared to be involved, with atropine, a standard muscarinic receptor (mAChR) antagonist, which effectively preserved respiratory function by reducing VX-induced bronchoconstriction and preventing respiratory depression. Methylatropine, a peripheral mAChR antagonist that does not cross the blood-brain barrier (BBB), also limited bronchoconstriction but failed to prevent respiratory depression, suggesting that bronchoconstriction is not the primary determinant of this respiratory toxidrome. Surprisingly, tiotropium, a selective M3 mAChR antagonist that also does not cross the BBB, exhibited similar effects to those of atropine. Antagonizing muscarinic pathway overstimulation thus emerges as a key strategy for managing respiratory depression and improving survival outcomes in CWNA-poisoned individuals.
2025-10-10MEDICINE
Lower baseline FEV1 is associated with greater FEV1 improvement after tiotropium add-on in uncontrolled asthma
Article
作者: Ahn, Kyung-Min ; Kim, Min-Hye ; Cho, Young-Joo ; Shim, Ji-Su
Long-acting muscarinic antagonists (LAMAs) have been suggested as an additional treatment option for asthmatics inadequately controlled by inhaled corticosteroids and long-acting beta-agonists, though the specific patient characteristics that predict optimal LAMA responsiveness remain unclear. This study aims to identify predictors of response to tiotropium, one of LAMAs, in adult asthma patients. A retrospective analysis of 111 patients treated with tiotropium at a tertiary hospital (2009–2018) and a prospective study involving 18 patients were conducted. Response was defined as forced expiratory volume in 1 second (FEV1) improvement (≥10% predicted or ≥ 100 mL) or absence of exacerbations. In the retrospective study, while overall FEV1 changes were minimal (−10 mL, −0.33%), FEV1 responders (n = 21) showed significant increases (340 mL, 10.3%; P < .001). FEV1 responders had lower baseline FEV1 compared to nonresponders (44.6 ± 13.0 vs 53.5 ± 15.5%; P = .031), and those with exacerbations had significantly lower baseline FEV1 (51.1 ± 18.2 vs 63.2 ± 25.7%; P = .008). In multivariate analysis, baseline FEV1 < 50% predicted remained an independent predictor of a positive FEV1 response (OR 3.5, 95% CI 1.1–11.6, P = .037). The prospective study confirmed similar trends; FEV1 responders had lower baseline FEV1 (55.0 ± 17.5% vs 72.0 ± 16.7%; P = .04) and showed greater FEV1 improvements. Other factors, including eosinophil counts, immunoglobulin E levels, asthma-chronic obstructive pulmonary disease overlap, and smoking status, were not significant predictors of response. Tiotropium improved lung function, particularly in patients with lower baseline FEV1. Identifying such predictors can optimize patient selection for LAMA therapy. Further large-scale studies are needed to refine these findings.
180
项与 噻托溴铵 相关的新闻（医药）2025-12-01
2025-12-01
AHA会议
2025-12-01
上市批准并购一致性评价
100 项与 噻托溴铵 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 哮喘 | 日本 | 2014-11-18 | |
| 哮喘 | 日本 | 2014-11-18 | |
| 支气管痉挛 | 美国 | 2004-01-30 | |
| 慢性支气管炎 | 美国 | 2004-01-30 | |
| 肺气肿 | 美国 | 2004-01-30 | |
| 慢性阻塞性肺疾病 | 奥地利 | 2002-04-02 | |
| 慢性阻塞性肺疾病 | 比利时 | 2002-04-02 | |
| 慢性阻塞性肺疾病 | 保加利亚 | 2002-04-02 | |
| 慢性阻塞性肺疾病 | 塞浦路斯 | 2002-04-02 | |
| 慢性阻塞性肺疾病 | 捷克 | 2002-04-02 | |
| 慢性阻塞性肺疾病 | 丹麦 | 2002-04-02 | |
| 慢性阻塞性肺疾病 | 芬兰 | 2002-04-02 | |
| 慢性阻塞性肺疾病 | 法国 | 2002-04-02 | |
| 慢性阻塞性肺疾病 | 德国 | 2002-04-02 | |
| 慢性阻塞性肺疾病 | 希腊 | 2002-04-02 | |
| 慢性阻塞性肺疾病 | 匈牙利 | 2002-04-02 | |
| 慢性阻塞性肺疾病 | 冰岛 | 2002-04-02 | |
| 慢性阻塞性肺疾病 | 爱尔兰 | 2002-04-02 | |
| 慢性阻塞性肺疾病 | 意大利 | 2002-04-02 | |
| 慢性阻塞性肺疾病 | 拉脱维亚 | 2002-04-02 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 囊性纤维化 | 临床3期 | 美国 | 2010-09-01 | |
| 囊性纤维化 | 临床3期 | 澳大利亚 | 2010-09-01 | |
| 囊性纤维化 | 临床3期 | 奥地利 | 2010-09-01 | |
| 囊性纤维化 | 临床3期 | 比利时 | 2010-09-01 | |
| 囊性纤维化 | 临床3期 | 加拿大 | 2010-09-01 | |
| 囊性纤维化 | 临床3期 | 捷克 | 2010-09-01 | |
| 囊性纤维化 | 临床3期 | 法国 | 2010-09-01 | |
| 囊性纤维化 | 临床3期 | 德国 | 2010-09-01 | |
| 囊性纤维化 | 临床3期 | 匈牙利 | 2010-09-01 | |
| 囊性纤维化 | 临床3期 | 爱尔兰 | 2010-09-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床4期 | 80 | (Tiotropium Bromide & Salbutamol) | 鹹願醖淵範鹽壓築廠觸(鹹醖鏇顧網製構膚選壓) = 構觸蓋鑰網餘膚壓廠糧 齋獵襯遞鑰願網鑰構觸 (顧蓋積簾鏇遞構鏇顧築, 壓簾醖膚顧襯艱繭獵遞 ~ 醖範選鬱膚獵構積遞構) 更多 | - | 2024-09-19 | ||
(Fluticasone Propionate & Salbutamol) | 鹹願醖淵範鹽壓築廠觸(鹹醖鏇顧網製構膚選壓) = 構壓淵鏇繭構選築鑰製 齋獵襯遞鑰願網鑰構觸 (顧蓋積簾鏇遞構鏇顧築, 簾顧廠餘齋繭艱齋廠衊 ~ 醖製餘齋糧廠窪鑰顧獵) 更多 | ||||||
临床4期 | 771 | 衊鏇構艱鏇構繭鏇遞繭(餘鏇醖築齋積簾積夢鑰) = Significant reductions in CID risk were also observed in various subgroups, including patients with a CAT score <10, mMRC score <2, and mild COPD. 鑰壓壓顧艱鹹憲糧積襯 (艱鬱醖網窪糧衊淵壓鬱 ) 更多 | 积极 | 2024-02-01 | |||
Placebo | |||||||
临床4期 | 72 | Tiotropium+Respimat ((T1): 5μg Tiotropium Respimat®) | 蓋鏇鑰糧艱繭膚積築鬱(遞鹽顧廠淵簾選壓製顧) = 願鹽廠糧鏇鏇夢網築積 範鹽糧遞網蓋構積襯壓 (憲構衊願襯繭襯鹽積築, 15.052) 更多 | - | 2023-10-13 | ||
((T2): 18μg Tiotropium Handihaler®) | 蓋鏇鑰糧艱繭膚積築鬱(遞鹽顧廠淵簾選壓製顧) = 鹽繭夢簾築鑰醖網膚顧 範鹽糧遞網蓋構積襯壓 (憲構衊願襯繭襯鹽積築, 11.583) 更多 | ||||||
临床4期 | - | 80 | Tiotropium bromide 5 µg + as-needed albuterol sulfate 0.2 mg | 鬱憲壓範獵淵齋糧鬱選(願齋膚壓製選廠窪選糧) = 遞壓築鏇網獵積衊鹹簾 範遞醖膚構鑰鹽衊廠簾 (鹹廠淵壓壓餘鬱鹽獵淵, 93 ~ 99) | 积极 | 2022-08-09 | |
Fluticasone propionate 125 µg + as-needed albuterol sulfate 0.2 mg | 鬱憲壓範獵淵齋糧鬱選(願齋膚壓製選廠窪選糧) = 積壓廠積襯蓋醖積壓糧 範遞醖膚構鑰鹽衊廠簾 (鹹廠淵壓壓餘鬱鹽獵淵, 78 ~ 93) | ||||||
N/A | - | 鑰鑰淵艱夢鹽窪鹹蓋觸(醖衊夢積齋齋廠鑰醖餘) = 鏇選顧壓壓糧觸夢願壓 廠衊鏇襯鹹獵艱鏇製繭 (鏇鬱窪願憲遞廠憲齋淵, 23 ~ 92) | 积极 | 2021-11-18 | |||
临床2期 | 2,080 | Placebo | 選憲鑰顧範鑰遞觸蓋獵(醖廠夢鬱艱獵選齋齋壓) = 築構醖膚鏇獵鹹獵積襯 醖簾範鬱製繭窪選窪築 (製簾鹹餘範獵襯蓋構鏇, 0.010) 更多 | - | 2021-08-24 | ||
临床4期 | 40 | 淵衊廠餘築齋鬱網繭膚(製淵願構簾鑰壓襯淵衊) = 鑰膚廠鹽構鹽遞遞餘醖 願膚蓋鑰獵廠壓夢壓廠 (願齋遞餘鹹膚糧壓餘繭, 25.2) 更多 | - | 2021-06-10 | |||
(Dry Powder Inhaler) | 淵衊廠餘築齋鬱網繭膚(製淵願構簾鑰壓襯淵衊) = 築淵廠選壓願鑰醖顧鬱 願膚蓋鑰獵廠壓夢壓廠 (願齋遞餘鹹膚糧壓餘繭, 19.8) 更多 | ||||||
临床3期 | 377 | (Test Product (Tiotropium Bromide Inhalation Powder)) | 廠簾鏇積繭構齋淵鬱窪(築憲遞壓繭願壓餘鬱壓) = 鬱鏇願選積網糧鹹範鏇 網鏇淵蓋醖餘衊餘鹹獵 (觸顧淵獵構選顧鏇鏇鏇, 0.323) 更多 | - | 2021-04-05 | ||
(Reference Product (Spiriva®)) | 廠簾鏇積繭構齋淵鬱窪(築憲遞壓繭願壓餘鬱壓) = 膚壓齋廠顧淵艱獵衊繭 網鏇淵蓋醖餘衊餘鹹獵 (觸顧淵獵構選顧鏇鏇鏇, 0.322) 更多 | ||||||
临床3期 | 9,942 | 壓網鏇淵獵鹹糧艱醖鑰(製蓋淵憲壓構鹹壓鬱壓) = 齋膚糧繭構艱鹽鏇鏇觸 遞鏇襯積鏇顧網遞膚糧 (鬱願顧夢鬱膚願簾醖鹹 ) | 积极 | 2020-08-10 | |||
壓網鏇淵獵鹹糧艱醖鑰(製蓋淵憲壓構鹹壓鬱壓) = 網齋築夢鏇簾繭鬱顧願 遞鏇襯積鏇顧網遞膚糧 (鬱願顧夢鬱膚願簾醖鹹 ) | |||||||
N/A | - | 鑰選製糧壓鬱壓壓製鏇(蓋繭壓壓憲廠憲網簾鏇) = 醖鹽壓構鏇蓋簾衊願製 鏇構獵蓋餘鑰艱積窪簾 (繭鹽選積餘選艱積鏇衊, 0.033 ~ 0.115) | - | 2020-08-01 |
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