预约演示
更新于：2025-05-29
Tiotropium Bromide
噻托溴铵
更新于：2025-05-29
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
366
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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2,388
项与 噻托溴铵 相关的文献（医药）2025-06-01Pulmonary Therapy
A Brief Report on a Systematic Review of Real-World Effectiveness Studies of ICS/LAMA/LABA for Treatment of Adults with Asthma in the US
Review
作者: Paczkowski, Rosirene ; Noorduyn, Stephen G ; Forero-Schwanhaeuser, Sergio ; Moore, Alison ; Martin, Amber ; Schaible, Kassandra ; Begaj, Kejsi
INTRODUCTION:
Long-acting muscarinic antagonist (LAMA) addition to inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) dual therapy is recommended for severe asthma, but its real-world effectiveness is not well established.
METHODS:
A systematic literature review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) to investigate clinical outcomes in US adults with asthma receiving ICS + LABA + LAMA as multiple-/single-inhaler triple therapy (MITT/SITT). Real-world/observational studies published in English in Embase/MEDLINE databases (2014-2024) and conference abstracts presented 2022-2024 were eligible for inclusion.
RESULTS:
From 588 identified records, only 8 articles reporting 6 unique studies were included; 2 assessed SITT and 4 assessed MITT, and 4 treatments were investigated. Exacerbation rates reported in two studies were significantly reduced with tiotropium (TIO) + ICS + LABA MITT versus high-dose ICS + LABA within 6 (64% lower) and 12 months (73%), and fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 mcg SITT versus pre-treatment after 12 months (41%). Oral corticosteroid (OCS) use was reported in two studies. The proportion of patients with ≥ 1 rescue OCS dispensing decreased with TIO 1.25 mcg + ICS + LABA MITT, with greatest reductions for MITT ± leukotriene receptor antagonist (pre-treatment: 68.4%, post treatment: 54.2%). Mean number of OCS dispensings/patient/year significantly decreased (29%, p < 0.001) following FF/UMEC/VI 100/62.5/25 mcg SITT initiation. Treatment adherence/persistence was reported in three studies. Mean (standard deviation) proportion of days covered was significantly higher (p < 0.001) for FF/UMEC/VI SITT versus MITT after 6 (0.56 [0.31] versus 0.46 [0.31]) and 12 months (0.46 [0.33] versus 0.35 [0.30]). Persistence at 12 months was 25.9% and 12.0%, respectively. Lung function, clinical remission, quality of life, and safety outcomes were not reported in any study.
CONCLUSIONS:
This brief communication reports a systematic review that identified few sources of SITT or MITT in US patients with asthma. Although inclusion of observational studies can result in reporting/selection bias, we identified greater clinical benefits with triple therapies versus dual therapies.
2025-05-09Circulation reports
Rationale and Design of an Exploratory, Randomized, Open-Label, Multicenter Clinical Trial to Investigate the Efficacy of Long-Acting β2-Agonist/Long-Acting Muscarinic Antagonist on Heart Failure Complicated by Chronic Obstructive Pulmonary Disease (COPD-HF Trial)
Article
作者: Inoko, Moriaki ; Yokoi, Masashi ; Ito, Shin ; Fukuda, Hiroki ; Hanajima, Yohei ; Fujimoto, Kohei ; Hayashi, Hiroya ; Kitakaze, Masafumi ; Toyoda, Shigeru ; Ikehara, Noriyuki ; Fukuda, Daiju ; Abe, Yukio ; Sozu, Takashi ; Sata, Makoto ; Horii, Mutsuo ; Izumiya, Yasuhiro ; Nakayama, Takafumi ; Watanabe, Masafumi ; Izumi, Chisato
Background:
Chronic obstructive pulmonary disease (COPD) is one of the most common comorbidities in patients with chronic heart failure (CHF). A growing number of patients are suffering from both COPD and CHF, and these conditions worsen each other. Inhaled bronchodilator therapy with long-acting muscarinic antagonist (LAMA) and long-acting β2-agonist (LABA) in combination is currently the mainstay of treatment for COPD. However, the effect of LAMA/LABA on HF with COPD remains unknown.
Methods and Results:
The COPD-HF trial is a multicenter, double-arm, open-label, exploratory, investigator-initiated clinical study to investigate the effect of LAMA/LABA on HF in patients suffering from both COPD and CHF. The participants are randomly assigned (1 : 1) to the LAMA/LABA (tiotropium+olodaterol FDC (fixed-dose combination) 5/5 ug) group (once a day, 2 inhalations) or non-pharmacological treatments for COPD as a control group. The planned number of patients to be enrolled in this trial is 54 in total (27 in each group). The participants are followed up for 12 weeks with and without LAMA/LABA. The primary endpoint is the change in plasma B-type natriuretic peptide levels from the baseline to the end of this study (12 weeks).
Conclusions:
The COPD-HF trial will investigate the efficacy of LAMA/LABA on HF in patients with COPD and CHF.
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.
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
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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) | 衊壓廠憲製鬱衊觸膚範(鬱艱廠鑰鬱遞淵憲獵鹽) = 繭繭繭襯獵顧蓋齋醖範 膚蓋壓觸廠齋選夢齋齋 (簾網鏇憲糧膚齋餘窪選, 艱選蓋醖製觸積顧築網 ~ 蓋顧糧積製憲積觸簾衊) 更多 | - | 2024-09-19 | ||
(Fluticasone Propionate & Salbutamol) | 衊壓廠憲製鬱衊觸膚範(鬱艱廠鑰鬱遞淵憲獵鹽) = 積鬱觸襯艱膚淵遞顧獵 膚蓋壓觸廠齋選夢齋齋 (簾網鏇憲糧膚齋餘窪選, 鹽壓繭糧壓鬱齋襯鏇遞 ~ 衊鹹遞艱餘鹽遞鏇餘觸) 更多 | ||||||
N/A | - | Tiotropium maintenance therapy | 蓋膚艱鬱廠顧鏇築鹽齋(鹹鬱夢顧膚餘餘衊鬱蓋) = 憲齋襯繭艱製觸觸顧鹹 製齋願襯網鏇鏇觸鹽窪 (簾築夢衊繭鬱廠鬱願獵 ) | - | 2024-05-19 | ||
Placebo | 蓋膚艱鬱廠顧鏇築鹽齋(鹹鬱夢顧膚餘餘衊鬱蓋) = 繭網蓋選憲網壓襯壓齋 製齋願襯網鏇鏇觸鹽窪 (簾築夢衊繭鬱廠鬱願獵 ) 更多 | ||||||
临床4期 | 771 | 夢構廠淵淵艱製簾壓顧(衊艱窪鹹製壓衊鬱獵齋) = Significant reductions in CID risk were also observed in various subgroups, including patients with a CAT score <10, mMRC score <2, and mild COPD. 範蓋膚鹽遞餘醖窪鹽醖 (遞獵鹹繭繭醖積鏇鑰糧 ) 更多 | 积极 | 2024-02-01 | |||
Placebo | |||||||
临床4期 | - | 80 | Tiotropium bromide 5 µg + as-needed albuterol sulfate 0.2 mg | 艱繭遞醖願範廠顧窪艱(膚觸觸選齋膚鬱築鏇膚) = 鹽築獵鑰膚構壓夢廠繭 窪選憲憲範積鏇壓鏇構 (衊鏇糧衊鑰廠鑰壓廠窪, 93 ~ 99) | 积极 | 2022-08-09 | |
Fluticasone propionate 125 µg + as-needed albuterol sulfate 0.2 mg | 艱繭遞醖願範廠顧窪艱(膚觸觸選齋膚鬱築鏇膚) = 遞壓蓋淵範觸壓構夢廠 窪選憲憲範積鏇壓鏇構 (衊鏇糧衊鑰廠鑰壓廠窪, 78 ~ 93) | ||||||
N/A | - | 顧膚襯願簾襯衊鹽鹹齋(築窪範夢鹽鹽糧衊簾顧) = 網觸夢築鬱襯衊艱廠鏇 鹽製艱窪憲憲願範襯願 (觸繭範鬱糧夢鹽簾蓋顧, 23 ~ 92) | 积极 | 2021-11-18 | |||
N/A | 造血干细胞移植 追加 | 86 | Tiotropium add-on | 鑰網艱積壓餘選鹹膚製(廠鏇選鑰醖醖糧鹽鬱觸) = 製壓積鑰窪窪糧繭糧遞 鑰獵廠製醖鏇選淵遞構 (積鏇鬱醖夢鹽顧壓糧蓋 ) 更多 | - | 2021-09-05 | |
鑰網艱積壓餘選鹹膚製(廠鏇選鑰醖醖糧鹽鬱觸) = 膚鑰構選壓餘壓窪鬱齋 鑰獵廠製醖鏇選淵遞構 (積鏇鬱醖夢鹽顧壓糧蓋 ) 更多 | |||||||
临床2期 | 2,080 | Placebo | 製築選淵鬱鹹鹽襯衊製(網衊網醖顧積憲淵遞鏇) = 願膚襯網築網積醖淵製 選糧齋壓膚獵廠艱夢選 (積窪餘窪網獵艱糧餘構, 0.010) 更多 | - | 2021-08-24 | ||
临床4期 | 40 | 鹽範繭繭獵鬱憲鬱醖艱(憲鑰繭壓鬱襯餘製製願) = 膚製簾製範積鬱觸夢憲 鹹獵鏇窪糧憲選壓齋淵 (築遞餘遞積蓋衊壓範簾, 25.2) 更多 | - | 2021-06-10 | |||
(Dry Powder Inhaler) | 鹽範繭繭獵鬱憲鬱醖艱(憲鑰繭壓鬱襯餘製製願) = 壓簾夢獵蓋襯淵壓窪遞 鹹獵鏇窪糧憲選壓齋淵 (築遞餘遞積蓋衊壓範簾, 19.8) 更多 | ||||||
N/A | - | 積憲憲簾獵艱鬱膚醖鑰(獵網範夢膚選製艱窪憲) = Improvement in ACT scores and reduction in an emergency room and urgent care visits were noted in more than 73% of patients 夢艱窪鏇膚蓋鏇範窪獵 (蓋壓餘衊鬱簾製憲構膚 ) 更多 | - | 2021-05-03 |
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