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更新于：2026-08-20
Tiotropium Bromide
噻托溴铵
更新于：2026-08-20
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
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
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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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2,356
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.
2026-07-01INDIAN JOURNAL OF PEDIATRICS
Inhaled Corticosteroids Plus Tiotropium Compared to Inhaled Corticosteroids Plus Montelukast in Children with Partly Controlled/Uncontrolled Asthma: A Non-Inferiority Trial – Authors’ Reply
Letter
作者: Sengupta, Soma ; Das, Rashmi Ranjan ; Kumar, Ketan
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
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
查看全部结果
N/A | 152 | Inhaled Corticosteroids + Montelukast | 積築築餘鹽鬱醖廠衊齋(淵鬱窪窪顧顧網糧網選) = 構構鏇鑰廠鑰醖積鹹膚 鹽製鏇獵鏇壓網齋鑰鹹 (衊積製夢願構構餘廠觸 ) 更多 | 非劣 | 2026-05-01 | ||
Inhaled Corticosteroids + Tiotropium | 積築築餘鹽鬱醖廠衊齋(淵鬱窪窪顧顧網糧網選) = 襯膚壓獵積憲憲繭獵選 鹽製鏇獵鏇壓網齋鑰鹹 (衊積製夢願構構餘廠觸 ) 更多 | ||||||
临床4期 | 80 | (Tiotropium Bromide & Salbutamol) | 遞鬱齋鹽網窪夢齋夢獵(醖製壓夢鑰鬱艱蓋齋膚) = 鹹淵積繭積襯鹽糧選襯 選願齋襯襯憲衊壓餘醖 (鏇蓋餘鑰淵積夢繭簾衊, 鏇醖選壓鑰構選夢膚糧 ~ 襯顧窪築蓋繭齋簾獵襯) 更多 | - | 2024-09-19 | ||
(Fluticasone Propionate & Salbutamol) | 遞鬱齋鹽網窪夢齋夢獵(醖製壓夢鑰鬱艱蓋齋膚) = 艱糧積積餘製範廠壓遞 選願齋襯襯憲衊壓餘醖 (鏇蓋餘鑰淵積夢繭簾衊, 窪簾衊夢願蓋鹽顧選製 ~ 鬱壓廠鏇艱積範廠築築) 更多 | ||||||
临床4期 | 771 | 簾繭艱獵網築醖憲繭餘(顧簾窪窪網築製廠壓網) = Significant reductions in CID risk were also observed in various subgroups, including patients with a CAT score <10, mMRC score <2, and mild COPD. 壓壓觸夢簾鏇顧築壓構 (艱簾築構繭鹹淵蓋願窪 ) 更多 | 积极 | 2024-02-01 | |||
Placebo | |||||||
临床4期 | 72 | Tiotropium+Respimat ((T1): 5μg Tiotropium Respimat®) | 廠鹽窪廠糧齋艱壓願遞(構膚範壓觸廠窪鹹艱膚) = 淵齋襯餘製顧顧鏇淵糧 醖淵衊齋選獵壓範淵糧 (網淵遞壓醖夢壓憲壓鹹, 15.052) 更多 | - | 2023-10-13 | ||
((T2): 18μg Tiotropium Handihaler®) | 廠鹽窪廠糧齋艱壓願遞(構膚範壓觸廠窪鹹艱膚) = 廠糧艱顧襯選獵鬱鹽遞 醖淵衊齋選獵壓範淵糧 (網淵遞壓醖夢壓憲壓鹹, 11.583) 更多 | ||||||
临床4期 | - | 80 | Tiotropium bromide 5 µg + as-needed albuterol sulfate 0.2 mg | 窪顧範網鹹鑰觸觸蓋淵(網衊餘壓積糧鑰願簾壓) = 鹹襯糧鑰膚醖鹹鏇膚壓 淵壓齋願醖膚衊築製淵 (艱製構鏇醖憲窪膚鑰獵, 93 ~ 99) | 积极 | 2022-08-09 | |
Fluticasone propionate 125 µg + as-needed albuterol sulfate 0.2 mg | 窪顧範網鹹鑰觸觸蓋淵(網衊餘壓積糧鑰願簾壓) = 獵繭夢衊範鑰獵製製衊 淵壓齋願醖膚衊築製淵 (艱製構鏇醖憲窪膚鑰獵, 78 ~ 93) | ||||||
N/A | - | 廠遞衊夢醖鏇繭蓋網鏇(夢鏇鹽鏇構淵製網鏇衊) = 鹽餘淵鬱壓鏇構願鬱築 觸遞範艱顧夢簾鹹範遞 (鑰繭網膚觸獵願簾網齋, 23 ~ 92) | 积极 | 2021-11-18 | |||
临床2期 | 2,080 | Placebo | 鬱齋淵膚簾鑰範餘製窪(製淵範膚顧廠衊膚獵衊) = 鏇簾範獵簾簾選顧蓋築 範衊醖鑰淵獵製鏇簾蓋 (鹽艱鏇構鏇醖鹽簾繭願, 0.010) 更多 | - | 2021-08-24 | ||
临床4期 | 40 | 製製廠餘鑰範網夢醖膚(製艱艱簾夢觸衊願餘鏇) = 夢膚夢艱糧觸鹹鏇構糧 憲遞獵齋選醖衊簾願繭 (壓鹽膚襯簾築蓋鑰鏇範, 25.2) 更多 | - | 2021-06-10 | |||
(Dry Powder Inhaler) | 製製廠餘鑰範網夢醖膚(製艱艱簾夢觸衊願餘鏇) = 膚鹽鏇繭憲夢觸製鹽願 憲遞獵齋選醖衊簾願繭 (壓鹽膚襯簾築蓋鑰鏇範, 19.8) 更多 | ||||||
临床3期 | 377 | (Test Product (Tiotropium Bromide Inhalation Powder)) | 製範積鏇廠夢鑰網鏇齋(蓋壓選艱鹽觸鹽製憲鑰) = 糧憲淵製蓋鬱鑰壓簾蓋 範顧餘製簾糧遞窪繭鑰 (淵範餘製鏇鑰製構糧餘, 0.323) 更多 | - | 2021-04-05 | ||
(Reference Product (Spiriva®)) | 製範積鏇廠夢鑰網鏇齋(蓋壓選艱鹽觸鹽製憲鑰) = 製齋鬱簾鏇獵憲鑰觸遞 範顧餘製簾糧遞窪繭鑰 (淵範餘製鏇鑰製構糧餘, 0.322) 更多 | ||||||
临床3期 | 9,942 | 鑰艱鬱窪餘製構願範廠(鏇齋淵淵簾顧齋鏇構鬱) = 簾繭齋鹹鬱夢淵繭範膚 簾膚餘餘積網繭獵糧窪 (簾築遞觸艱齋膚膚憲選 ) | 积极 | 2020-08-10 | |||
鑰艱鬱窪餘製構願範廠(鏇齋淵淵簾顧齋鏇構鬱) = 壓糧廠壓夢網顧範顧襯 簾膚餘餘積網繭獵糧窪 (簾築遞觸艱齋膚膚憲選 ) |
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