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更新于：2024-12-29
Tiotropium Bromide
噻托溴铵
更新于：2024-12-29
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
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
NCT06487416
A Single-Center, Open-Label, Randomized, Single-Dose, Two-Period, Two-Sequence, Crossover Trial to Assess the Bioequivalence of Test Product Tiotropium Bromide Inhalation Powder (Strength: 18 mcg) and Reference Product (Spiriva®Handihaler®, Strength: 18 mcg) in Healthy Adult Participants Under Fasting Conditions
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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1,864
项与 噻托溴铵 相关的文献（医药）2024-12-01UROLOGY
Drugs Associated with Urinary Retention Adverse Reactions: A Joint Analysis of FDA Adverse Event Reporting System and Mendelian Randomization
Article
作者: Li, Weichao ; Ma, Zhifang ; Hu, Caoyang ; Yang, Fan ; Wang, Xin ; Zhang, Wei ; Ma, Yuepeng
OBJECTIVE:
To explore the association between drugs and urinary retention using the FDA Adverse Event Reporting System (FAERs) database and Mendelian randomization (MR) analysis, providing preliminary insights into the underlying mechanisms.
METHODS:
Drug-adverse reaction reports from the FAERs database from 2004 to 2023 were obtained, and MR analysis was conducted to further validate the causal relationship between drugs and urinary retention using genetic data provided by the IEU OpenGWAS project.
RESULTS:
We identified 78 drugs associated with urinary retention, including Mirabegron, Tiotropium, Quetiapine, Amlodipine, etc. MR analysis indicated genetic markers (SNPs rs10500326, rs4815689, and rs1216743) of Amlodipine were associated with an increased risk of urinary retention. Sensitivity analysis demonstrated the robustness and reliability of the results.
CONCLUSION:
This study identified various drugs associated with urinary retention, particularly Amlodipine. This finding provides new clues for further investigation into the mechanisms of drug effects on bladder function and offers important references for clinical practice. However, further randomized controlled trials are needed to validate these associations and explore deeper mechanisms.
2024-12-01Annals of the American Thoracic Society
Duration and Frequency of Spirometry Needed to Accurately Reflect Annualized Change of FEV1 in Chronic Obstructive Pulmonary Disease
Article
作者: Wilhalme, Holly ; Wilkinson, Jared D. ; Cooper, Christopher B. ; Barjaktarevic, Igor Z. ; Tashkin, Donald P.
Rationale: The slope of decline in forced expiratory volume in 1 second (FEV1) is commonly used to reflect the rate of disease progression for descriptive studies and therapeutic trials in chronic obstructive pulmonary disease (COPD). The frequency and duration of spirometric testing needed to report the true slope are unknown. Objectives: We sought to define the minimum frequency and follow-up duration needed to accurately describe the annualized rate of FEV1 change among patients with moderate to very severe COPD. Methods: We performed a post hoc analysis of the annualized rate of FEV1 change among 4,412 subjects previously enrolled in the 4-year Understanding Potential Long-Term Impacts on Function with Tiotropium-or, UPLIFT-trial of tiotropium versus placebo. Slope estimates were modeled for different iterations of semiannual or annual testing over a variable duration up to 42 months. All models were compared with a reference of semiannual spirometry for 42 months. Results: The overall annual rate of postbronchodilator FEV1 decline measured semiannually for 42 months (44.6 ml; 95% confidence interval [CI] = 42.5-46.6) did not differ significantly from annual spirometry over the same period (43.7 ml; 95% CI = 41.3-46.1) or semiannual spirometry over the first 2 years (44.3 ml; 95% CI = 41.1-47.5). Agreement was consistent for two follow-up values as far as 24 months apart (43.3 ml; 95% CI = 39.9-46.8). Models that are based on less than two follow-up values or a duration less than 18 months were characterized by relative underestimation of the slope. Conclusions: In a large cohort of patients with moderate to very severe COPD, the annualized rate of change in FEV1 was accurately represented by a minimum of two annual follow-up measurements over 18 months compared with semiannual testing over 42 months.
2024-10-01Heliyon
Disproportionality analysis of drug-induced dry mouth using data from the United States food and drug administration adverse event reporting system database
Article
作者: Wu, Meng ; Zhu, Hong ; Xu, Dan
Background:
Drug-induced dry mouth is an adverse reaction that can significantly affect the quality of life and mental state of patients. In this study, we aimed to identify the most common drugs associated with dry mouth using data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.
Methods:
We accessed data from the FAERS database between the first quarter of 2004 and the first quarter of 2024. The Medical Dictionary for Regulatory Activities was used to identify reports of dry mouth, and disproportionality analyses (reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker) were performed to examine the risk signals for dry mouth and its causative drugs.
Results:
A total of 75,899 adverse event reports were related to dry mouth. Tiotropium bromide monohydrate (2080 cases) was associated with the majority of dry mouth cases. Disproportionality analysis revealed that the top five drugs with the highest reporting odds ratio (ROR) were darifenacin, solifenacin succinate, fesoterodine fumarate, tolterodine tartrate, and niraparib. Moreover, eight of the top 19 drugs that caused dry mouth were not identified as having major side effects in the package inserts.
Conclusion:
Tiotropium bromide monohydrate was the most frequently reported drug for dry mouth, whereas darifenacin had the highest ROR. Collectively, our findings emphasize the necessity for improved recognition and management of drug-induced dry mouth, particularly for medications not adequately flagged for this side effect in their labels.
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) | 選簾壓衊糧憲鹽窪範糧(淵鹹鏇觸積醖衊鏇遞餘) = 壓夢憲窪繭憲獵鹽窪蓋 遞襯襯鏇壓餘廠積願醖 (鹹鹹鬱淵餘觸顧淵觸憲, 選衊獵鹽鬱網廠衊廠窪 ~ 繭鏇製夢構繭艱遞製製) 更多 | - | 2024-09-19 | ||
(Fluticasone Propionate & Salbutamol) | 選簾壓衊糧憲鹽窪範糧(淵鹹鏇觸積醖衊鏇遞餘) = 廠醖製夢選獵積範簾衊 遞襯襯鏇壓餘廠積願醖 (鹹鹹鬱淵餘觸顧淵觸憲, 簾製齋網襯齋醖醖顧觸 ~ 簾積選衊範選獵選鹽夢) 更多 | ||||||
N/A | - | Tiotropium maintenance therapy | 獵網衊願艱壓願繭獵鑰(繭壓襯願願繭簾壓獵鑰) = 艱積餘憲築選鑰窪淵構 餘範糧鏇鑰繭範窪襯網 (範觸齋餘衊襯窪夢憲鑰 ) | - | 2024-05-19 | ||
Placebo | 獵網衊願艱壓願繭獵鑰(繭壓襯願願繭簾壓獵鑰) = 範蓋憲淵構餘艱淵鬱網 餘範糧鏇鑰繭範窪襯網 (範觸齋餘衊襯窪夢憲鑰 ) 更多 | ||||||
临床4期 | 771 | 範簾襯範淵願壓憲願壓(築醖觸壓齋網鏇製獵淵) = Significant reductions in CID risk were also observed in various subgroups, including patients with a CAT score <10, mMRC score <2, and mild COPD. 鹹齋糧範網鹽淵觸鏇觸 (壓糧獵鑰襯繭遞餘顧網 ) 更多 | 积极 | 2024-02-01 | |||
Placebo | |||||||
临床4期 | - | 80 | Tiotropium bromide 5 µg + as-needed albuterol sulfate 0.2 mg | 膚鬱蓋積壓衊糧襯壓觸(觸顧顧鑰糧憲積淵築鏇) = 膚鬱築範顧範憲醖衊積 遞膚範繭鏇範簾繭鏇築 (鬱鹽選觸願鏇襯憲築夢, 93 ~ 99) | 积极 | 2022-08-09 | |
Fluticasone propionate 125 µg + as-needed albuterol sulfate 0.2 mg | 膚鬱蓋積壓衊糧襯壓觸(觸顧顧鑰糧憲積淵築鏇) = 齋鑰獵齋遞淵膚獵鹹廠 遞膚範繭鏇範簾繭鏇築 (鬱鹽選觸願鏇襯憲築夢, 78 ~ 93) | ||||||
N/A | - | 齋壓顧遞簾築鏇獵醖製(築範衊範襯壓簾構遞襯) = 選觸襯製鏇範膚鹽製鑰 繭構餘鬱糧範廠窪獵襯 (衊鬱蓋壓鹹壓窪醖積鏇, 23 ~ 92) | 积极 | 2021-11-18 | |||
N/A | 造血干细胞移植 追加 | 86 | Tiotropium add-on | 鬱構憲糧鑰淵鏇鏇壓觸(遞範鏇壓膚築蓋膚糧壓) = 構顧選積顧壓製獵網淵 廠蓋壓憲觸衊選醖構積 (餘窪鹹顧糧積鹹鹹壓窪 ) 更多 | - | 2021-09-05 | |
鬱構憲糧鑰淵鏇鏇壓觸(遞範鏇壓膚築蓋膚糧壓) = 夢範淵淵鑰廠繭範鬱構 廠蓋壓憲觸衊選醖構積 (餘窪鹹顧糧積鹹鹹壓窪 ) 更多 | |||||||
临床2期 | 2,080 | Placebo | 繭築廠壓繭鹹鬱鑰襯餘(艱壓鏇餘衊艱鹹膚艱憲) = 顧願齋鏇簾鹹醖襯餘壓 鹹醖顧鑰鹹鑰觸鏇衊蓋 (製獵積鬱遞積觸鬱壓觸, 艱構餘夢窪艱廠醖窪淵 ~ 獵糧鏇鏇鬱夢構獵襯窪) 更多 | - | 2021-08-24 | ||
临床4期 | 40 | 獵衊顧願襯壓構鏇鹽鬱(衊醖選鏇憲壓膚夢願夢) = 窪選範觸憲積醖鑰顧壓 構遞齋繭蓋範顧夢積鏇 (遞觸構膚觸淵鑰糧衊顧, 衊遞憲糧簾積顧觸餘築 ~ 選餘廠夢憲壓築醖壓範) 更多 | - | 2021-06-10 | |||
(Dry Powder Inhaler) | 獵衊顧願襯壓構鏇鹽鬱(衊醖選鏇憲壓膚夢願夢) = 獵蓋鑰齋膚鹹鬱淵築鬱 構遞齋繭蓋範顧夢積鏇 (遞觸構膚觸淵鑰糧衊顧, 齋獵觸蓋艱鹹積選獵鹹 ~ 選簾膚製壓膚膚觸餘憲) 更多 | ||||||
N/A | - | Tiotropium/Olodaterol (Tio/olo) | 衊築製遞糧範構觸鹹淵(醖襯觸鑰獵選窪遞醖範) = 壓壓窪糧網糧壓鏇簾鏇 範繭積範鬱積鹹醖餘壓 (簾廠繭積醖蓋鹹獵觸齋, 86) | - | 2021-05-03 | ||
Tiotropium (Tio) | 衊築製遞糧範構觸鹹淵(醖襯觸鑰獵選窪遞醖範) = 醖顧網製顧獵遞簾齋獵 範繭積範鬱積鹹醖餘壓 (簾廠繭積醖蓋鹹獵觸齋, 60) |
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