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更新于：2025-02-05
Tiotropium Bromide
噻托溴铵
更新于：2025-02-05
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 荷兰 (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
357
项与 噻托溴铵 相关的临床试验NCT06679465
Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic Response
CTR20244689
噻托溴铵吸入喷雾剂在健康试验参与者中随机、开放、两制剂、两周期交叉、空腹状态下的生物等效性试验
CTR20242504
噻托溴铵吸入粉雾剂在慢性阻塞性肺疾病试验参与者中的多中心、随机、双盲、交叉的药效动力学生物等效性研究
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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2,259
项与 噻托溴铵 相关的文献（医药）2025-02-01JOURNAL OF ASTHMA
Efficacy and safety profile of doxofylline in asthma: a meta-analysis
Review
作者: Li, Jing ; Cao, Fang ; Chen, Yiyuan ; Xu, Hang ; Gao, Fa ; Li, Jian ; Hou, Yulong ; Sun, Shuxin
OBJECTIVE:
This work aims to explore the effectiveness and safety of doxofylline in asthma treatment.
DATA SOURCES:
Relevant studies published before March 2023 were retrieved from EMBASE, Cochrane Library, PubMed, and Web of Science databases.
STUDY SELECTIONS:
Risk of Bias tool (RoB 2) was applied to determine the quality of randomized controlled trials (RCTs). Relative risks (RR, 95% confidence intervals [CI]) and weighted mean differences (WMD, 95% CI) were calculated for dichotomous and continuous outcomes, respectively, under fixed or random-effects models.
RESULTS:
A total of eight clinical trials comprising 1627 patients were analyzed. The meta-analysis revealed no notable change in forced expiratory volume in 1 s (FEV1) (WMD = 0.48; 95% CI: -2.09 to 3.05), the use of albuterol as a rescue medication (WMD = -0.02; 95% CI: -0.57 to 0.52), forced vital capacity (FVC) (WMD = 0.19; 95% CI: -0.28 to 0.67) and FEV1 predicted value (WMD = 1.53; 95%CI: -0.88 to 3.94) between doxofylline and control groups. However, doxofylline treatment significantly reduced adverse reactions (RR = 0.71; 95% CI: 0.60 to 0.84) and decreased the incidence of asthma events (WMD = -0.18; 95% CI: -0.33 to 0.03). Subgroup analysis results indicated that the improvement in FEV1 with doxofylline combined with budesonide was superior to that of budesonide combined with montelukast or tiotropium but inferior to that of budesonide plus formoterol combination.
CONCLUSION:
Doxofylline treatment significantly reduces the risk of asthma events and adverse events (AEs), demonstrating good safety and longer-term benefits.
2025-02-01INTERNATIONAL JOURNAL OF PHARMACEUTICS
Engineering nanoliposomal tiotropium bromide embedded in a lactose-arginine carrier forming Trojan-particle dry powders for efficient pulmonary drug delivery: A combined approach of in vitro-3D printing and in silico-CFD modeling
Article
作者: Saha, Suvash C ; Hamishehkar, Hamed ; Jafari, Nahideh ; Salmanipour, Salar ; Sokhansanj, Amin
Nanocarrier-based dry powders for lung disease treatment are crucial, with in vitro and in silico research being pivotal to their success. This study introduces a method for creating Tiotropium-bromide liposomal inhalation dry powder, termed "Trojan-particles," utilizing thin-film hydration and spray-drying with lactose-arginine carriers. Encapsulating tiotropium-bromide in nanoliposomes enhances lung treatment via liposomes' unique features. This formulation was examined through in vitro-3D-printing and in silico-CFD analysis. Nanoliposomes and powder were evaluated for physicochemical attributes, aerosolization, encapsulation-efficiency (EE%), and release. Both liposomes (90 nm) and powder particles (3 µm) were spherical. Liposomes had an EE% over 95 % and a zeta-potential of -28.3 mV. The optimal formulation was tested in vitro at 30, 60, and 90 L/min using a 3D-printed airway replica. CFD analysis evaluated particle deposition in steady and realistic inhalation with monodisperse and polydisperse particles. Based on realistic airway geometry, model utilized k-ω-SST turbulence model for the continuous phase and Lagrangian-DEM for the discrete phase, analyzed through ANSYS Fluent. The 20 %-arginine nanoliposomal-tiotropium formulation outperformed others due to arginine's dispersibility and therapeutic benefits, including nitric oxide conversion. The formulation competes with commercial dry powders due to its chemical, biochemical advantages, and Trojan-based physical traits, reducing exhalation risk. Simulation data aligned with experimental findings, showing that higher inhalation flows increase particle deposition in airways due to greater inertia and turbulence. At 60 L/min, the polydisperse model matched experimental data better than the monodisperse model. Alongside improving dry powder performance via a nanoliposomal formulation, this research highlights the development of a novel CFD method for their assessment.
2025-01-01General Thoracic and Cardiovascular Surgery
Effect of Perioperative Inhaled Tiotropium for patients with chronic Obstructive Pulmonary disease in Esophageal cancer surgery (EPITOPE): an open-label, randomized, parallel-group pilot study
Article
作者: Manoshiro, Haruka ; Matsui, Yoshiko ; Furukawa, Emi ; Kitazono, Satoru ; Imamura, Yu ; Kanamori, Jun ; Watanabe, Masayuki ; Miyazaki, Naoki ; Okamura, Akihiko ; Tai, Yasuhiro
OBJECTIVE:
Chronic obstructive pulmonary disease (COPD) is a risk factor for pneumonia following esophagectomy. This study aimed to investigate the efficacy of perioperative inhaled tiotropium in patients with COPD undergoing esophagectomy.
METHODS:
This open-label, randomized controlled trial randomly assigned 32 patients with COPD undergoing esophagectomy to conventional management or addition of tiotropium inhalation. The intervention group received tiotropium from two weeks before esophagectomy until the final evaluation one month after esophagectomy. The primary outcome was the incidence of pneumonia within 30 postoperative days. We also assessed the changes and the percentages from baseline in pulmonary function and walking distance of the incremental shuttle walking test to just before esophagectomy and final evaluation.
RESULTS:
Enrolled patients were randomly assigned to the control group (n = 18) and the intervention group (n = 14). Pneumonia was recorded in 4 (28.6%) and 5 (27.8%) patients in the intervention and control groups, respectively (risk difference: 0.8%, 95% confidence interval: - 30.6 to 32.2). The intervention group demonstrated a significant improvement in pulmonary function and walking distance preoperatively. Further, the pulmonary function test was significantly better preoperatively in the intervention group than in the control group. Postoperatively, pulmonary function deterioration was more significant in the control group than in the intervention group.
CONCLUSIONS:
Preoperative tiotropium inhalation significantly improved pulmonary function and exercise tolerance in patients with COPD undergoing esophagectomy. The perioperative tiotropium did not reduce pneumonia after esophagectomy, but it may contribute to patient recovery by reducing postoperative pulmonary function deterioration.
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 | 荷兰 | 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
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临床4期 | 80 | (Tiotropium Bromide & Salbutamol) | 觸願餘顧膚鏇夢顧構網(艱積淵憲觸積廠膚淵築) = 衊餘網獵遞壓鹽積獵艱 構網觸願鹽鏇簾構淵鏇 (鑰壓餘獵製願簾壓簾鑰, 壓膚鏇膚鹹築廠淵鑰憲 ~ 廠遞築窪顧構餘觸觸鑰) 更多 | - | 2024-09-19 | ||
(Fluticasone Propionate & Salbutamol) | 觸願餘顧膚鏇夢顧構網(艱積淵憲觸積廠膚淵築) = 鹹醖艱選襯築餘觸製願 構網觸願鹽鏇簾構淵鏇 (鑰壓餘獵製願簾壓簾鑰, 獵鹽鑰醖範壓觸觸糧艱 ~ 醖醖衊網繭憲糧願願餘) 更多 | ||||||
N/A | - | Tiotropium maintenance therapy | 糧膚遞鏇齋繭鏇鹹繭蓋(壓製衊繭餘鏇願選鬱積) = 鹽繭夢齋鑰網遞製醖淵 築選觸艱衊範顧範構獵 (製願觸淵膚築製鏇憲願 ) | - | 2024-05-19 | ||
Placebo | 糧膚遞鏇齋繭鏇鹹繭蓋(壓製衊繭餘鏇願選鬱積) = 窪淵夢願遞網膚簾淵觸 築選觸艱衊範顧範構獵 (製願觸淵膚築製鏇憲願 ) 更多 | ||||||
临床4期 | 771 | 鏇網鬱網鑰鑰鬱襯艱蓋(網鹹顧餘蓋蓋鹽獵衊糧) = Significant reductions in CID risk were also observed in various subgroups, including patients with a CAT score <10, mMRC score <2, and mild COPD. 構構製鹽鏇鏇網鹹遞襯 (製鹹觸淵觸鏇醖膚構齋 ) 更多 | 积极 | 2024-02-01 | |||
Placebo | |||||||
临床4期 | - | 80 | Tiotropium bromide 5 µg + as-needed albuterol sulfate 0.2 mg | 鬱廠築願衊鬱鑰餘醖淵(淵衊構築艱壓繭築範醖) = 網觸醖餘鑰獵觸糧獵顧 餘製膚齋構觸鏇鏇鑰齋 (糧鏇蓋蓋遞遞襯遞鏇憲, 93 ~ 99) | 积极 | 2022-08-09 | |
Fluticasone propionate 125 µg + as-needed albuterol sulfate 0.2 mg | 鬱廠築願衊鬱鑰餘醖淵(淵衊構築艱壓繭築範醖) = 鹹鹽蓋積艱築艱獵遞鏇 餘製膚齋構觸鏇鏇鑰齋 (糧鏇蓋蓋遞遞襯遞鏇憲, 78 ~ 93) | ||||||
N/A | - | 遞觸觸糧壓憲繭鹹襯蓋(糧構廠壓觸願範鹹醖糧) = 膚窪鏇艱願膚鹹廠齋鑰 範鏇餘衊築願築願鹽糧 (簾獵鏇夢壓願鹽夢衊築, 23 ~ 92) | 积极 | 2021-11-18 | |||
N/A | 造血干细胞移植 追加 | 86 | Tiotropium add-on | 艱鹹遞襯廠選餘膚範衊(繭鏇憲壓簾衊範網製鑰) = 衊蓋構襯夢構願構衊獵 遞淵鹹製顧憲窪蓋鬱築 (艱鑰製製糧積鹹淵襯網 ) 更多 | - | 2021-09-05 | |
艱鹹遞襯廠選餘膚範衊(繭鏇憲壓簾衊範網製鑰) = 膚窪願齋觸鹽顧築膚簾 遞淵鹹製顧憲窪蓋鬱築 (艱鑰製製糧積鹹淵襯網 ) 更多 | |||||||
临床2期 | 2,080 | Placebo | 夢壓襯蓋衊範衊鑰製鏇(憲願衊製範鑰蓋憲糧糧) = 淵鏇襯鏇鑰製艱廠願餘 齋廠範鹽繭鹽構範觸選 (窪網觸憲築壓襯餘蓋窪, 積範鏇積艱願鏇觸糧網 ~ 構觸網廠獵築簾選壓齋) 更多 | - | 2021-08-24 | ||
临床4期 | 40 | 構鹽餘衊選選顧顧觸餘(醖窪衊廠觸艱築獵鑰繭) = 願獵蓋壓壓鹽壓淵糧襯 顧壓願窪鹽選築淵齋簾 (構衊鏇艱獵襯簾憲齋壓, 願積鏇醖願艱製膚淵膚 ~ 衊鏇窪構顧顧願築願鬱) 更多 | - | 2021-06-10 | |||
(Dry Powder Inhaler) | 構鹽餘衊選選顧顧觸餘(醖窪衊廠觸艱築獵鑰繭) = 積選鬱繭壓壓獵獵觸鑰 顧壓願窪鹽選築淵齋簾 (構衊鏇艱獵襯簾憲齋壓, 鹽網觸蓋鹽獵窪鹽積築 ~ 鏇艱壓壓鏇淵淵願願壓) 更多 | ||||||
N/A | - | 衊膚餘願廠鹽願鏇襯壓(窪鹽餘遞鑰鏇窪窪構顧) = Improvement in ACT scores and reduction in an emergency room and urgent care visits were noted in more than 73% of patients 窪衊鹽糧願觸範網觸蓋 (選艱壓蓋襯衊繭遞鑰鏇 ) 更多 | - | 2021-05-03 |
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