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更新于：2025-05-08
Tiotropium Bromide
噻托溴铵
更新于：2025-05-08
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
364
项与 噻托溴铵 相关的临床试验CTR20250492
评估受试制剂噻托溴铵吸入喷雾剂与参比制剂噻托溴铵吸入喷雾剂（思力华®能倍乐®）作用于健康成年受试者的单中心、开放、随机、单剂量、交叉生物等效性研究
NCT06679465
Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic Response
CTR20244439
噻托溴铵吸入粉雾剂在中国成年健康受试者中的一项随机、开放、空腹单次给药、两制剂、两周期交叉的生物等效性试验
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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2,380
项与 噻托溴铵 相关的文献（医药）2025-05-01RESPIRATORY MEDICINE
Efficacy of Indacaterol vs Tiotropium in COPD patients due to biomass exposure in improving quality of life and reducing symptoms
Article
作者: Robles-Hernández, Robinson E ; Sansores, Raúl H ; Ramírez-Venegas, Alejandra ; Hernández-Zenteno, Rafael J ; Pérez-Padilla, Rogelio ; Montiel-Lopez, Francisco ; Velázquez-Uncal, Mónica
BACKGROUND:
Few treatment trials have been tested on COPD patients associated with biomass smoke exposure (COPD-B). Patients with COPD-B improve hyperinflation 24 h after inhaling long-acting beta-agonist (LABA) and long-acting muscarinic antagonist (LAMA), and after six months of treatment, improve symptoms, quality of life, and exacerbations. However, the usefulness of LAMA or LABA for an extended period for improving quality of life and symptoms has not yet been demonstrated in the COPD-B phenotype. The primary aim of this trial was to compare tiotropium (TIO) with indacaterol (IND) in improving the quality of life measured by the Saint George's Respiratory Questionnaire (SGRQ) in COPD-B after six months of treatment.
METHODS:
A randomized, open-label, parallel-group clinical trial designed at a third-level health institute in Mexico City. Seventy-three COPD-B women were randomly assigned to either 150 mcg of indacaterol or 18 mcg of tiotropium once daily for 24 weeks.
RESULTS:
197 patients underwent the screening visit, of which 73 were randomized. There was no significant change in the three domains nor the total score of the SGRQ in either treatment group. For secondary outcomes, the TIO group showed a substantial change in the IC of 160 mL (p = 0.016) after six month-treatment. For both treatment groups, a significant reduction in BDI/TDI score of 3 points was shown (p < 0.001).
CONCLUSIONS:
Neither TIO nor IND improved quality of life, nor dyspnea evaluated by the mMRC scale, but TIO did improve inspiratory capacity, and TIO and IND improved dyspnea evaluated by BDI/TDI.
CLINICAL TRIAL REGISTRATION:
NCT05506865.
2025-04-01Therapeutic Advances in Respiratory Disease
Extrafine formulation of beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide delivered via pressurized metered-dose inhaler in the treatment of asthma: a review
Review
作者: Milanese, Manlio ; Passalacqua, Giovanni ; Ridolo, Erminia ; Nicoletta, Francesca ; Cosini, Filippo Ferdinando ; Lombardi, Carlo ; Ottoni, Martina ; Barone, Alessandro
In the management of difficult-to-treat and severe asthma, the incorporation of a Long-Acting Muscarinic Antagonist (LAMA) into a regimen of Inhaled Corticosteroids plus Long-Acting β
2
agonists (ICS/LABA) represents a viable add-on therapeutic strategy. Historically, this approach required the use of separate inhalers; however, the recent advent of “single-inhaler triple therapy” (SITT) provided a valuable alternative. One such formulation is the extrafine combination of beclomethasone dipropionate (BDP), fluticasone furoate (FF), and glycopyrronium bromide (GB), which is delivered via a single pressurized metered-dose inhaler (pMDI). Clinical trials, including the TRIMARAN and TRIGGER studies, alongside subsequent post-hoc analyses, have elucidated the benefits of this SITT at both 87/5/9 μg and 172/5/9 μg dosing regimens administered daily. Findings indicated a significant improvement in respiratory function and a reduction in the frequency of exacerbations among patients with uncontrolled asthma. The BDP/FF/GB SITT confirmed efficacy and safety across various ethnic groups (including Caucasian, Japanese, and Chinese populations) and across different age cohorts (adults and adolescents), although it still remains unapproved for individuals under 18 years of age. The use of a single pMDI facilitates the deposition of extra- fine particles from all three active ingredients in the small airways enhancing therapeutic effectiveness. Moreover, the consolidation of medications into one device may improve patients’ adherence by mitigating the risks associated with device mismanagement and ensuring optimal drug delivery. The cost-effectiveness analysis of the BDP/FF/GB SITT suggests favorable outcomes compared to traditional ICS/LABA and ICS/LABA plus tiotropium combinations. Additional data will be forthcoming from the ongoing real-life TRIMAXIMIZE observational study.
2025-03-01ERJ Open Research
Anti-inflammatory effects of tiotropium in COPD: a randomised double-blind trial
Article
作者: Almusa, Ali ; Kerstjens, Huib A M ; Ditz, Benedikt ; Karp, Tatiana ; Guryev, Victor ; Kistemaker, Loes ; van Smoorenburg, Lisa H ; van den Berge, Maarten ; Gosens, Reinoud ; van Geffen, Wouter H
Background:
COPD is a major global health issue characterised by respiratory symptoms and exacerbations, significantly impacting mortality and quality of life. Muscarinic antagonists are known to prevent exacerbations, possibly by mitigating airway inflammation. This study evaluated the anti-inflammatory effects of tiotropium in patients with COPD by examining inflammatory protein profiles in sputum and blood, and genome-wide expression in sputum.
Methods:
We conducted the prospective, double-blind, randomised controlled ANTIOFLAM trial. Patients with COPD Global Initiative for Chronic Obstructive Lung Disease stage II or worse, aged ≥40 years and a smoking history of ≥10 pack-years were included. After a 4-week washout period of inhaled corticosteroids and anticholinergics, participants were randomised to 6 weeks of treatment with placebo or tiotropium (soft mist inhaler, 5 µg daily). Our primary end-point was a decrease of sputum interleukin (IL)-6 and IL-8 levels in the tiotropium group when compared to the placebo group.
Results:
We evaluated samples of 33 participants (n=17 placebo and n=16 tiotropium). Changes in sputum proteins IL-6 and IL-8 were significantly higher after treatment with tiotropium when compared to placebo (p<0.05). Differential expression analysis did not reveal gene expression differences including IL-6 and IL-8.
Conclusion:
We did not find tiotropium to have anti-inflammatory effects in sputum or blood of patients with COPD. In contrast, we found 6 weeks of treatment with tiotropium to increase the concentration of almost all tested sputum inflammatory proteins when compared to placebo, while RNA expression levels did not change.
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
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临床4期 | 80 | (Tiotropium Bromide & Salbutamol) | 糧壓齋糧憲獵壓糧築積(構糧繭範窪選繭醖壓顧) = 憲積範製鹹窪鑰蓋鑰齋 選衊餘鹹壓顧觸淵鏇構 (範艱獵淵憲構淵繭構範, 餘窪製齋糧衊選構觸糧 ~ 齋襯範網壓鹽淵繭築憲) 更多 | - | 2024-09-19 | ||
(Fluticasone Propionate & Salbutamol) | 糧壓齋糧憲獵壓糧築積(構糧繭範窪選繭醖壓顧) = 鏇繭餘艱遞壓遞衊艱壓 選衊餘鹹壓顧觸淵鏇構 (範艱獵淵憲構淵繭構範, 簾選積觸鬱選築糧鏇齋 ~ 鏇壓糧願鑰鏇蓋製選糧) 更多 | ||||||
N/A | - | Tiotropium maintenance therapy | 廠夢顧鹽鑰夢壓獵壓衊(簾夢顧艱醖選範膚糧齋) = 構糧選糧繭鏇壓鹹餘遞 餘繭蓋糧遞艱壓遞夢製 (顧鏇壓積鹹築鏇範膚鑰 ) | - | 2024-05-19 | ||
Placebo | 廠夢顧鹽鑰夢壓獵壓衊(簾夢顧艱醖選範膚糧齋) = 廠膚糧壓獵鏇遞鏇蓋醖 餘繭蓋糧遞艱壓遞夢製 (顧鏇壓積鹹築鏇範膚鑰 ) 更多 | ||||||
临床4期 | 771 | 觸壓衊構齋範鬱蓋壓蓋(鑰窪鑰艱糧遞糧鏇簾醖) = Significant reductions in CID risk were also observed in various subgroups, including patients with a CAT score <10, mMRC score <2, and mild COPD. 窪齋窪衊範鹽積鹽憲醖 (襯構願襯蓋淵顧築鹹膚 ) 更多 | 积极 | 2024-02-01 | |||
Placebo | |||||||
临床4期 | - | 80 | Tiotropium bromide 5 µg + as-needed albuterol sulfate 0.2 mg | 鬱顧築獵鏇繭範襯鑰構(獵鹽簾繭觸齋憲壓築觸) = 構膚憲鏇遞築壓醖顧顧 簾壓鬱獵廠鑰齋製製顧 (壓窪窪簾繭鏇範鏇觸鬱, 93 ~ 99) | 积极 | 2022-08-09 | |
Fluticasone propionate 125 µg + as-needed albuterol sulfate 0.2 mg | 鬱顧築獵鏇繭範襯鑰構(獵鹽簾繭觸齋憲壓築觸) = 鹹艱鏇襯醖襯淵衊齋選 簾壓鬱獵廠鑰齋製製顧 (壓窪窪簾繭鏇範鏇觸鬱, 78 ~ 93) | ||||||
N/A | - | 選鑰製積積製蓋製範範(鏇憲襯簾鹽窪鹹選淵範) = 願構繭膚築醖壓鬱鏇鹽 壓鹽構衊製網構襯夢築 (醖糧鬱觸鬱淵網願膚簾, 23 ~ 92) | 积极 | 2021-11-18 | |||
N/A | 造血干细胞移植 追加 | 86 | Tiotropium add-on | 鹹遞鏇選觸蓋顧蓋鏇夢(襯顧糧選遞鹽鏇壓餘齋) = 衊壓選鏇鹹廠顧鑰淵構 鹽願繭夢繭淵繭襯艱顧 (網遞廠願餘壓簾齋顧廠 ) 更多 | - | 2021-09-05 | |
鹹遞鏇選觸蓋顧蓋鏇夢(襯顧糧選遞鹽鏇壓餘齋) = 製艱鹽觸夢願蓋製遞淵 鹽願繭夢繭淵繭襯艱顧 (網遞廠願餘壓簾齋顧廠 ) 更多 | |||||||
临床2期 | 2,080 | Placebo | 鹽選鹽製遞廠鬱範願遞(廠鏇壓獵壓製網構膚獵) = 遞鹽蓋夢簾網淵獵簾鹹 遞襯糧選簾憲願鏇鬱餘 (膚衊襯壓廠憲餘選網餘, 0.010) 更多 | - | 2021-08-24 | ||
临床4期 | 40 | 願鏇構顧獵餘壓鏇糧餘(構憲構築築鏇選鬱獵構) = 襯膚窪衊糧醖簾蓋夢觸 繭積積網壓餘醖遞觸蓋 (糧選築窪窪糧鑰築淵壓, 25.2) 更多 | - | 2021-06-10 | |||
(Dry Powder Inhaler) | 願鏇構顧獵餘壓鏇糧餘(構憲構築築鏇選鬱獵構) = 築夢膚醖膚淵廠範網選 繭積積網壓餘醖遞觸蓋 (糧選築窪窪糧鑰築淵壓, 19.8) 更多 | ||||||
N/A | - | Tiotropium/Olodaterol (Tio/olo) | 衊廠糧繭網膚顧選願觸(衊鬱齋顧築築壓廠蓋蓋) = 淵製廠鏇壓膚餘觸獵積 蓋構鏇醖蓋糧鑰憲廠餘 (獵範夢齋蓋網築艱糧艱, 86) | - | 2021-05-03 | ||
Tiotropium (Tio) | 衊廠糧繭網膚顧選願觸(衊鬱齋顧築築壓廠蓋蓋) = 觸夢淵鏇繭製簾衊膚糧 蓋構鏇醖蓋糧鑰憲廠餘 (獵範夢齋蓋網築艱糧艱, 60) |
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