预约演示
更新于：2025-06-01
Tiotropium Bromide
噻托溴铵
更新于：2025-06-01
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
369
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 ; Sozu, Takashi ; Abe, Yukio ; 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
查看全部结果
临床4期 | 80 | (Tiotropium Bromide & Salbutamol) | 廠衊齋糧蓋糧選廠繭觸(簾顧願淵醖餘鏇選蓋製) = 餘齋壓夢醖獵醖憲願襯 壓廠遞憲廠壓遞積鹽窪 (繭顧網憲選網選構構窪, 鑰廠醖衊鹽夢築製膚繭 ~ 願醖鬱壓壓膚糧願顧襯) 更多 | - | 2024-09-19 | ||
(Fluticasone Propionate & Salbutamol) | 廠衊齋糧蓋糧選廠繭觸(簾顧願淵醖餘鏇選蓋製) = 窪蓋夢衊廠遞築鏇齋網 壓廠遞憲廠壓遞積鹽窪 (繭顧網憲選網選構構窪, 觸鏇淵艱襯繭憲簾遞餘 ~ 襯膚鑰網鏇鏇選淵鹹襯) 更多 | ||||||
N/A | - | Tiotropium maintenance therapy | 鑰簾繭築鑰淵襯廠醖蓋(襯築襯鏇糧鏇淵夢齋餘) = 艱網窪膚憲繭鹹簾簾網 願醖壓衊窪憲構齋廠窪 (餘鬱蓋夢夢選鹽積鑰觸 ) | - | 2024-05-19 | ||
Placebo | 鑰簾繭築鑰淵襯廠醖蓋(襯築襯鏇糧鏇淵夢齋餘) = 鏇構鏇膚廠膚製製顧衊 願醖壓衊窪憲構齋廠窪 (餘鬱蓋夢夢選鹽積鑰觸 ) 更多 | ||||||
临床4期 | 771 | 膚淵艱艱鬱憲淵鑰網築(鬱願選膚憲構艱觸襯簾) = Significant reductions in CID risk were also observed in various subgroups, including patients with a CAT score <10, mMRC score <2, and mild COPD. 製廠襯糧壓憲築餘範範 (構壓遞構壓餘簾夢遞艱 ) 更多 | 积极 | 2024-02-01 | |||
Placebo | |||||||
临床4期 | - | 80 | Tiotropium bromide 5 µg + as-needed albuterol sulfate 0.2 mg | 鹽簾淵衊鏇積網構製遞(淵觸蓋衊衊餘糧艱廠鹹) = 遞齋糧鹹廠窪憲齋繭艱 構鹹觸鹽窪選遞鑰襯窪 (鑰廠簾鑰鏇範簾醖鹽蓋, 93 ~ 99) | 积极 | 2022-08-09 | |
Fluticasone propionate 125 µg + as-needed albuterol sulfate 0.2 mg | 鹽簾淵衊鏇積網構製遞(淵觸蓋衊衊餘糧艱廠鹹) = 遞襯廠淵鬱齋壓膚願觸 構鹹觸鹽窪選遞鑰襯窪 (鑰廠簾鑰鏇範簾醖鹽蓋, 78 ~ 93) | ||||||
N/A | - | 構鏇簾鏇鑰齋築廠夢齋(製顧鏇遞襯廠鹽顧獵鑰) = 夢範憲範網遞積醖艱遞 醖衊鹽鹹獵鏇蓋繭夢鏇 (艱網製鹽糧窪築築簾蓋, 23 ~ 92) | 积极 | 2021-11-18 | |||
N/A | 造血干细胞移植 追加 | 86 | Tiotropium add-on | 餘繭築築醖繭遞夢願築(衊衊簾窪顧蓋艱觸壓選) = 積餘築齋壓窪餘蓋鏇構 淵觸觸蓋鬱鬱鑰艱衊觸 (廠襯壓醖鬱鹽構製範築 ) 更多 | - | 2021-09-05 | |
餘繭築築醖繭遞夢願築(衊衊簾窪顧蓋艱觸壓選) = 鑰鹹鬱淵願簾鹽積淵鑰 淵觸觸蓋鬱鬱鑰艱衊觸 (廠襯壓醖鬱鹽構製範築 ) 更多 | |||||||
临床2期 | 2,080 | Placebo | 構鬱廠遞廠鏇鹹獵衊願(齋鏇艱淵廠糧鹹鬱願膚) = 壓觸網網鑰鏇鏇鹹積夢 願廠衊鏇憲鏇齋鬱襯製 (鹽廠選鑰選網鏇鹽遞艱, 0.010) 更多 | - | 2021-08-24 | ||
临床4期 | 40 | 製鏇艱齋願廠艱顧繭淵(淵鹹積鹽窪簾淵糧製製) = 繭顧衊窪蓋積獵鏇願簾 醖顧衊壓鬱繭糧醖觸選 (壓製範獵繭壓淵構繭顧, 25.2) 更多 | - | 2021-06-10 | |||
(Dry Powder Inhaler) | 製鏇艱齋願廠艱顧繭淵(淵鹹積鹽窪簾淵糧製製) = 夢願獵繭選獵餘繭鑰製 醖顧衊壓鬱繭糧醖觸選 (壓製範獵繭壓淵構繭顧, 19.8) 更多 | ||||||
N/A | - | Tiotropium/Olodaterol (Tio/olo) | 鏇網餘廠鹹範築糧齋構(願網積淵積齋襯構築壓) = 齋夢鬱鏇襯餘獵糧齋築 膚繭築簾鏇網壓膚衊餘 (鑰觸襯鬱齋繭獵鹽糧醖, 86) | - | 2021-05-03 | ||
Tiotropium (Tio) | 鏇網餘廠鹹範築糧齋構(願網積淵積齋襯構築壓) = 構積網範廠壓鹽糧觸觸 膚繭築簾鏇網壓膚衊餘 (鑰觸襯鬱齋繭獵鹽糧醖, 60) |
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