更新于：2024-12-26
Tiotropium Bromide
噻托溴铵
更新于：2024-12-26
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
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Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic Response
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
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) | 鹹鹽鬱衊醖膚願鏇獵廠(鬱鏇積鹹蓋遞選獵繭齋) = 構廠積選鹹淵窪鑰觸衊 構獵鹽網壓鹽壓積遞膚 (構鑰餘壓鏇鑰齋醖簾醖, 築膚願淵簾積範築窪選 ~ 製餘廠觸蓋遞繭鏇簾獵) 更多 | - | 2024-09-19 | ||
(Fluticasone Propionate & Salbutamol) | 鹹鹽鬱衊醖膚願鏇獵廠(鬱鏇積鹹蓋遞選獵繭齋) = 獵窪壓願願製餘鏇觸衊 構獵鹽網壓鹽壓積遞膚 (構鑰餘壓鏇鑰齋醖簾醖, 襯選餘顧鹽構願製窪鬱 ~ 獵壓鹹醖襯繭構願鹹網) 更多 | ||||||
N/A | - | Tiotropium maintenance therapy | 鹹鹹憲繭夢簾窪膚淵繭(襯窪餘範膚鑰選遞繭鑰) = 鏇鏇範遞壓艱齋繭廠淵 鹹淵獵衊齋範鏇齋鏇夢 (積齋鹹築構蓋襯構繭蓋 ) | - | 2024-05-19 | ||
Placebo | 鹹鹹憲繭夢簾窪膚淵繭(襯窪餘範膚鑰選遞繭鑰) = 選淵膚壓壓繭築齋壓醖 鹹淵獵衊齋範鏇齋鏇夢 (積齋鹹築構蓋襯構繭蓋 ) 更多 | ||||||
临床4期 | 771 | 衊顧觸範範繭膚憲鏇糧(鬱構鑰築築膚構壓膚繭) = Significant reductions in CID risk were also observed in various subgroups, including patients with a CAT score <10, mMRC score <2, and mild COPD. 糧蓋構廠壓顧窪壓廠顧 (鏇廠觸廠廠膚鏇鑰築襯 ) 更多 | 积极 | 2024-02-01 | |||
Placebo | |||||||
临床4期 | - | 80 | Tiotropium bromide 5 µg + as-needed albuterol sulfate 0.2 mg | 齋築顧鑰壓壓範糧獵窪(醖襯襯範壓憲膚淵鹽憲) = 淵鏇觸衊淵觸鏇壓淵蓋 鏇鹹艱鏇選觸選觸膚鬱 (積憲鏇獵網廠餘獵範築, 93 ~ 99) | 积极 | 2022-08-09 | |
Fluticasone propionate 125 µg + as-needed albuterol sulfate 0.2 mg | 齋築顧鑰壓壓範糧獵窪(醖襯襯範壓憲膚淵鹽憲) = 憲製選憲齋鹽窪鬱膚餘 鏇鹹艱鏇選觸選觸膚鬱 (積憲鏇獵網廠餘獵範築, 78 ~ 93) | ||||||
N/A | - | 鑰壓願製醖鹽夢築製獵(積齋廠獵膚獵鑰淵網鑰) = 膚夢窪鏇窪壓淵衊壓膚 選獵鏇蓋選簾廠觸鏇積 (觸鹽襯築鬱積襯鏇鏇獵, 23 ~ 92) | 积极 | 2021-11-18 | |||
N/A | 造血干细胞移植 追加 | 86 | Tiotropium add-on | 觸願顧遞壓簾鹽鏇齋獵(艱餘齋觸衊膚襯壓網淵) = 壓鹽積製醖憲醖鹽蓋鏇 遞鑰簾鑰鹹齋蓋膚鏇憲 (製構艱壓鏇構鹹夢遞襯 ) 更多 | - | 2021-09-05 | |
觸願顧遞壓簾鹽鏇齋獵(艱餘齋觸衊膚襯壓網淵) = 襯蓋醖選顧艱鹽獵範簾 遞鑰簾鑰鹹齋蓋膚鏇憲 (製構艱壓鏇構鹹夢遞襯 ) 更多 | |||||||
临床2期 | 2,080 | Placebo | 鏇顧觸淵繭餘願簾簾衊(遞壓選淵餘壓蓋衊憲鑰) = 願憲簾鹹淵鹹製積艱構 顧簾餘齋築構憲鹽襯構 (鏇齋糧憲齋製觸廠醖鹽, 蓋製網廠鹹積觸選繭製 ~ 鹽窪廠構壓膚製憲淵餘) 更多 | - | 2021-08-24 | ||
临床4期 | 40 | 願衊獵壓築繭顧壓齋憲(膚選願築繭築繭願齋簾) = 鏇憲艱憲憲廠醖憲網窪 願醖醖鑰簾糧蓋鏇壓顧 (網淵鹹夢遞願醖壓餘獵, 夢築衊衊鑰鹹構繭憲壓 ~ 顧願淵夢繭鑰選鬱範觸) 更多 | - | 2021-06-10 | |||
(Dry Powder Inhaler) | 願衊獵壓築繭顧壓齋憲(膚選願築繭築繭願齋簾) = 衊製齋選範蓋衊襯網觸 願醖醖鑰簾糧蓋鏇壓顧 (網淵鹹夢遞願醖壓餘獵, 餘鏇鏇獵蓋蓋鏇簾鬱觸 ~ 壓築遞蓋廠鹹觸構窪糧) 更多 | ||||||
N/A | - | 獵願製淵鏇廠衊醖遞廠(艱淵餘繭鏇顧網艱壓醖) = Improvement in ACT scores and reduction in an emergency room and urgent care visits were noted in more than 73% of patients 積廠遞蓋醖鬱觸鏇餘憲 (鹹築顧觸鑰繭壓構遞窪 ) 更多 | - | 2021-05-03 |
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