预约演示
更新于：2026-07-13
Tiotropium Bromide
噻托溴铵
更新于：2026-07-13
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) |
登录后查看时间轴
结构/序列
分子式C19H24BrNO5S2 |
InChIKeyMQLXPRBEAHBZTK-SEINRUQRSA-M |
CAS号411207-31-3 |
关联
436
项与 噻托溴铵 相关的临床试验CTR20261342
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（SPIRIVA® RESPIMAT®）作用于健康成年试验参与者的单中心、开放、随机、单剂量、交叉生物等效性试验
ChiCTR2500113245
A Multicenter, Randomized, Open-Label, Parallel-Group Study to Evaluate Early Intervention with Budesonide/Glycopyrronium/Formoterol Fumarate MDI in Patients with Mild and Moderate Chronic Obstructive Pulmonary Disease with Treatable Traits
NCT07267130
Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects in China
100 项与 噻托溴铵 相关的临床结果
登录后查看更多信息
100 项与 噻托溴铵 相关的转化医学
登录后查看更多信息
100 项与 噻托溴铵 相关的专利（医药）
登录后查看更多信息
2,353
项与 噻托溴铵 相关的文献（医药）2026-09-01JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Simultaneous quantification and aerodynamic particle size distribution analysis of tiotropium bromide and olodaterol in nebulized aerosol using UHPLC-MS/MS
Article
作者: Chen, Chao ; Dou, Jing ; Qian, Renyun ; Yuan, Chenxing ; Zhu, Difeng ; Hong, Yawen
Fixed-dose combination (FDC) inhaled aerosols require precise characterization of both active pharmaceutical ingredients (APIs) and aerodynamic properties to ensure therapeutic efficacy and safety. This study established and validated a sensitive, high-throughput ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) method for the simultaneous quantification of tiotropium bromide (TTP, a long-acting muscarinic antagonist) and olodaterol (ODT, a long-acting β2-adrenergic agonist) in nebulized aerosols, coupled with comprehensive aerodynamic particle size distribution (APSD) analysis. The optimized method employed a 50% methanol-water solution as the extraction solvent, with isocratic elution using 0.1% formic acid in water-methanol (50:50, v/v) and multiple reaction monitoring (MRM) in positive ionization mode. The total analysis time was only 3 min, enabling high-throughput analysis. Method validation confirmed excellent linearity for both analytes over the range of 0.5-16 ng/mL (r > 0.998), with a lower limit of quantification (LLOQ) of 0.5 ng/mL. Intra- and inter-batch precision (relative standard deviation, RSD) were < 7.5%, and extraction recoveries ranged from 98.1% to 98.8% (RSD<3%), with good matrix effect tolerance, solution stability (24 h at room temperature/4°C), and dilution integrity. A combination of syringe aspiration and Andersen Cascade Impactor (ACI) sampling was used to characterize aerosol properties at 2 and 8 min of nebulization. Both TTP and ODT exhibited uniform and stable aerosol concentrations (RSD<3.5%), with mass median aerodynamic diameters (MMAD) of 1.87-2.35 μm, geometric standard deviations (GSD) of 2.13-2.44, and fine particle fractions (FPF) exceeding 90%. The proportion of ultrafine particles (<0.41 μm) captured by the micro-orifice collector (MOC) was < 4%, confirming optimal particle size distribution for deep lung deposition. Application of this method to the evaluation of theoretical delivered doses in animal safety assessment tests showed that the doses were 4.7-8.6 times the rat equivalent dose, meeting the design requirements for toxicological studies. This method provides a robust framework for quality control, generic drug consistency evaluation, and preclinical toxicology of TTP/ODT nebulized aerosols, supporting the development of FDC inhaled therapies for chronic obstructive pulmonary disease (COPD).
2026-07-01LARYNGOSCOPE
Utility of Unified Spasmodic Dysphonia Rating Scale for Adductor Type Laryngeal Dystonia (
AdLD
)
Article
作者: Rosen, Clark A. ; Young, VyVy N. ; Marshall, Camryn R. ; Schneider, Sarah L. ; Yang, Sky T.
ABSTRACT:
Objective:
The Unified Spasmodic Dysphonia Rating Scale (USDRS) was developed in 1997 to standardize evaluation of adductor‐type laryngeal dystonia (AdLD) but has been sparsely utilized since then. The goal of this study was to explore the descriptive value and contemporary relevance of the USDRS in characterizing AdLD by examining its relationships with established patient‐reported, clinician‐perceptual, and acoustic measures.
Methods:
Patients with stable‐dose, botulinum toxin‐A (BtxA)‐responsive AdLD presented to a tertiary laryngology center for follow‐up BtxA injections. USDRS, PROMs (Voice Handicap Index‐10, Dyspnea Index, OMNI‐Vocal Effort Scale, and Communicative Participation Item Bank‐10), and voice recordings were obtained. Acoustic analysis was completed, and voice‐specialized speech‐language pathologists blindly rated voices using the Consensus Auditory Perceptual Evaluation–Voice (CAPE‐V). Descriptive statistics compared each measurement with USDRS results.
Results:
Forty‐four patients (mean age 58.4 years) were evaluated in this study. The USDRS demonstrated significantly lower variance than all other clinician‐ and patient‐reported outcomes as well as acoustic analysis. Comparison of overall USDRS score to other outcome measures demonstrated statistically significant, positive correlations: USDRS versus VHI‐10 (
R
= 0.451,
p
= 0.002), Overall Severity (
R
= 0.482,
p
= 0.004), and Strain (
R
= 0.487,
p
= 0.004), respectively.
Conclusions:
The USDRS exhibited restricted variability relative to VHI‐10, CAPE‐V, and CPP‐S and did not appear to add information beyond these measures; therefore, it may be limited for monitoring treatment response in AdLD patients.
Level of Evidence:
4.
2026-07-01Respiratory Investigation
Adherence to LAMA/LABA therapies in middle-aged patients with chronic obstructive pulmonary disease: A group-based trajectory analysis
Article
作者: Miyamoto, Atsushi ; Yoshida, Satomi ; Fukasawa, Toshiki ; Kawakami, Koji ; Watanabe, Tetsuya ; Asai, Kazuhisa ; Hirai, Kaho ; Liu, Hao ; Akaike, Takenori
BACKGROUND:
Longitudinal adherence patterns to LAMA/LABA therapy among middle-aged patients with COPD are not well understood. Because individuals aged 40-64 years typically self-manage medications with fewer age-related influences on adherence, this population allows clearer evaluation of temporal patterns. We therefore conducted a descriptive study among middle-aged patients to classify adherence trajectories and identify groups at risk of suboptimal adherence.
METHODS:
Using a Japanese claims database, we identified COPD patients aged 40-64 years who initiated glycopyrronium/indacaterol (GLY/IND), umeclidinium/vilanterol (UMEC/VI), or tiotropium/olodaterol (TIO/OLO). Group-based trajectory modeling was applied to the monthly proportion of days covered over 360 days to identify groups of patients with similar longitudinal adherence patterns.
RESULTS:
The analysis included 240 GLY/IND initiators, 365 UMEC/VI initiators, and 496 TIO/OLO initiators. For GLY/IND initiators, three adherence groups were identified: consistently high (31.7%), gradually declining (17.1%), and immediately declining (51.3%). UMEC/VI initiators demonstrated four groups: consistently high (26.6%), gradually declining (9.9%), rapidly declining (19.7%), and immediately declining (43.8%). TIO/OLO initiators also showed three groups: consistently high (35.5%), gradually declining (20.0%), and immediately declining (44.6%). Across all cohorts, higher adherence groups more frequently had a greater comorbidity burden and fewer previous moderate exacerbations, whereas suboptimal adherence groups tended to be younger, included more women, and initiated LAMA/LABA therapy in clinical settings.
CONCLUSIONS:
Middle-aged patients with COPD initiating LAMA/LABA therapy exhibited distinct adherence trajectories. Understanding these patterns may help inform more targeted approaches to support adherence and improve patient outcomes.
100 项与 噻托溴铵 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 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
登录
| 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 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | 152 | Inhaled Corticosteroids + Montelukast | 窪觸繭齋網觸鹽獵築糧(鑰構餘願襯齋廠鏇廠網) = 簾鏇膚顧鹹鬱鹽積鹹鏇 餘範齋觸願積鬱鏇簾醖 (遞願壓齋夢廠築醖壓齋 ) 更多 | 非劣 | 2026-05-01 | ||
Inhaled Corticosteroids + Tiotropium | 窪觸繭齋網觸鹽獵築糧(鑰構餘願襯齋廠鏇廠網) = 廠襯獵憲遞衊憲鹽鹽構 餘範齋觸願積鬱鏇簾醖 (遞願壓齋夢廠築醖壓齋 ) 更多 | ||||||
临床4期 | 80 | (Tiotropium Bromide & Salbutamol) | 獵蓋壓築鑰鏇簾鏇憲選(鬱餘廠鏇鹽網鏇鑰憲積) = 觸壓鏇艱鬱積顧窪窪廠 網鏇願憲獵簾憲衊窪簾 (網鏇壓鑰鹽艱襯獵網觸, 築願膚觸鑰鏇餘壓蓋築 ~ 鑰繭襯繭築觸壓壓淵鑰) 更多 | - | 2024-09-19 | ||
(Fluticasone Propionate & Salbutamol) | 獵蓋壓築鑰鏇簾鏇憲選(鬱餘廠鏇鹽網鏇鑰憲積) = 壓糧窪遞餘獵顧願夢築 網鏇願憲獵簾憲衊窪簾 (網鏇壓鑰鹽艱襯獵網觸, 鏇壓構鬱膚網糧構蓋製 ~ 遞願遞鹽壓網選觸醖壓) 更多 | ||||||
临床4期 | 771 | 築簾鹹簾醖範憲鹹鬱簾(襯餘鑰憲積顧製衊壓簾) = Significant reductions in CID risk were also observed in various subgroups, including patients with a CAT score <10, mMRC score <2, and mild COPD. 襯選淵膚製範鏇膚壓願 (願廠齋廠遞積壓餘窪簾 ) 更多 | 积极 | 2024-02-01 | |||
Placebo | |||||||
临床4期 | 72 | Tiotropium+Respimat ((T1): 5μg Tiotropium Respimat®) | 衊艱積選簾窪糧艱艱築(蓋鹹觸餘淵遞獵遞艱觸) = 齋糧簾繭淵餘齋艱壓獵 網鹽鏇鑰憲築積鏇簾餘 (醖範窪顧鬱艱膚襯鬱遞, 15.052) 更多 | - | 2023-10-13 | ||
((T2): 18μg Tiotropium Handihaler®) | 衊艱積選簾窪糧艱艱築(蓋鹹觸餘淵遞獵遞艱觸) = 繭齋願廠觸願網鑰築蓋 網鹽鏇鑰憲築積鏇簾餘 (醖範窪顧鬱艱膚襯鬱遞, 11.583) 更多 | ||||||
临床4期 | - | 80 | Tiotropium bromide 5 µg + as-needed albuterol sulfate 0.2 mg | 網夢鬱築齋繭顧範獵鹹(積構築鹽觸襯獵憲鹽遞) = 鬱積願壓憲鏇製獵壓網 積獵襯鏇簾繭選願憲築 (選壓艱窪繭膚遞衊鬱糧, 93 ~ 99) | 积极 | 2022-08-09 | |
Fluticasone propionate 125 µg + as-needed albuterol sulfate 0.2 mg | 網夢鬱築齋繭顧範獵鹹(積構築鹽觸襯獵憲鹽遞) = 遞鑰遞構憲齋製積網壓 積獵襯鏇簾繭選願憲築 (選壓艱窪繭膚遞衊鬱糧, 78 ~ 93) | ||||||
N/A | - | 鬱壓憲壓範繭齋膚窪糧(願齋蓋艱積憲齋夢廠鑰) = 簾壓淵齋獵衊積膚獵醖 夢廠築鹹獵鑰廠繭鬱鬱 (顧觸糧觸願製鹹築壓鹽, 23 ~ 92) | 积极 | 2021-11-18 | |||
临床2期 | 2,080 | Placebo | 製積鑰壓顧遞觸壓膚壓(顧製積遞鏇選鹹製獵齋) = 夢獵鏇醖衊獵鏇鹽鑰夢 壓衊鹽築鑰獵鹹衊壓壓 (鹹觸遞鹹齋製製壓範齋, 0.010) 更多 | - | 2021-08-24 | ||
临床4期 | 40 | 鏇壓糧衊獵窪繭淵壓積(蓋壓觸餘積繭襯網鹹簾) = 蓋築積願鹽選糧壓鑰鹽 齋醖鏇壓範廠範衊選蓋 (繭願衊憲壓願鹹願鏇觸, 25.2) 更多 | - | 2021-06-10 | |||
(Dry Powder Inhaler) | 鏇壓糧衊獵窪繭淵壓積(蓋壓觸餘積繭襯網鹹簾) = 簾鬱憲簾襯鹹構艱顧蓋 齋醖鏇壓範廠範衊選蓋 (繭願衊憲壓願鹹願鏇觸, 19.8) 更多 | ||||||
临床3期 | 377 | (Test Product (Tiotropium Bromide Inhalation Powder)) | 廠製願鹽顧願構醖顧餘(願鹽顧選構襯糧構範壓) = 選製簾積築觸構淵積簾 網築顧顧夢鹹鏇餘襯醖 (醖製襯齋顧鬱簾窪鏇選, 0.323) 更多 | - | 2021-04-05 | ||
(Reference Product (Spiriva®)) | 廠製願鹽顧願構醖顧餘(願鹽顧選構襯糧構範壓) = 壓製蓋積遞築觸鏇積蓋 網築顧顧夢鹹鏇餘襯醖 (醖製襯齋顧鬱簾窪鏇選, 0.322) 更多 | ||||||
临床3期 | 9,942 | 廠網鬱構積鏇遞鏇觸鹹(醖鹽鬱醖鏇夢鏇廠繭觸) = 顧壓顧築鏇鬱齋糧網遞 積鏇醖夢糧網獵壓鹹衊 (選鹹顧糧淵窪鹽蓋積鏇 ) | 积极 | 2020-08-10 | |||
廠網鬱構積鏇遞鏇觸鹹(醖鹽鬱醖鏇夢鏇廠繭觸) = 餘廠艱鏇構蓋糧網衊範 積鏇醖夢糧網獵壓鹹衊 (選鹹顧糧淵窪鹽蓋積鏇 ) |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
芽仔
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用