预约演示
更新于：2025-06-04
Beclometasone Dipropionate/Formoterol Fumarate
二丙酸倍氯米松/富马酸福莫特罗
更新于：2025-06-04
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2013-02-04), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C28H37ClO7 |
InChIKeyKUVIULQEHSCUHY-XYWKZLDCSA-N |
CAS号5534-09-8 |
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关联
72
项与 二丙酸倍氯米松/富马酸福莫特罗 相关的临床试验CTR20244460
倍氯米松福莫特罗吸入气雾剂在健康受试者中的随机、开放、两制剂、单次给药、两周期、双交叉生物等效性试验
CTR20243827
倍氯米松福莫特罗吸入气雾剂人体药代动力学生物等效性（PK-BE）研究
CTIS2024-512792-13-00
- CLI-05993BB1-01
100 项与 二丙酸倍氯米松/富马酸福莫特罗 相关的临床结果
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100 项与 二丙酸倍氯米松/富马酸福莫特罗 相关的转化医学
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100 项与 二丙酸倍氯米松/富马酸福莫特罗 相关的专利（医药）
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42
项与 二丙酸倍氯米松/富马酸福莫特罗 相关的文献（医药）2025-01-01RESPIRATORY MEDICINE
Particularities of deposition of two ICS-LABA fixed dose combination dry powder aerosol drugs in the airways of COPD patients
Article
作者: Gálffy, Gabriella ; Kis, Erika ; Ilyés, Norbert ; Sánta, Balázs ; Horváth, Alpár ; Böcskei, Renáta Marietta ; Farkas, Árpád ; Kovács, Tamás ; Bártfai, Zoltán ; Réti, Izolda ; Havadtői, Botond
The aim of this study was to analyse the effect of breathing parameters, age, gender and disease status on the lung doses of the two ICS + LABA fixed combination dry powder drugs. Breathing parameters of 113 COPD patients were measured while inhaling through emptied NEXThaler® and Ellipta® inhalers and the corresponding lung doses were calculated. Lung dose of Foster® NEXThaler® was superior to the lung dose of Relvar® Ellipta® in around 85 % of the patients. The average value of the ratio of bronchiolar to bronchial deposition fractions was 5.0 for Foster® NEXThaler® and 2.6 for Relvar® Ellipta®. Lung dose was sensitive to the inhalation parameters, such as peak inhalation flow, inhaled volume and breath-hold time. For both studied drugs the dose to the lungs was relatively high for moderate PIF values, but it declined for low (<35 L/min) and high (>95 L/min) PIFs. The lung dose increased by the increase of the inhaled volume, but saturated over 1.0 L of inhaled air. Longer breath-hold time led to higher lung deposition, but the dependence was drug-specific. FEV1 (%) and FEV1/FVC (%) did not influence the lung dose significantly (p = 0.05). Exacerbating patients had lower lung doses (28.8 ± 5.8 % for Foster® NEXThaler® and 23.7 ± 3.8 % for Relvar® Ellipta®) than their non-exacerbating counterparts (33.7 ± 6.1 % for Foster® NEXThaler® and for 24.9 ± 3.9 % for Relvar® Ellipta®). The exact clinical consequences of the differences between the deposition distributions of the two drugs could be assessed only by systematic clinical trials.
2024-12-31COPD-Journal of Chronic Obstructive Pulmonary Disease
Beclometasone Dipropionate/Formoterol Fumarate is Similarly Effective to Budesonide/Formoterol Fumarate in Chinese Patients with COPD: The FORSYYN Double-Blind, Randomised Study
Article
作者: Mei, Xiaodong ; Wu, Yanmin ; Wen, Fuqiang ; Corradi, Massimo ; Calabro, Emanuele ; Cappellini, Glauco ; Zhu, Yingqun ; Zhu, Cissy ; Amodio, Sergio ; Galkin, Dmitry ; Xing, Chunyan ; Chen, Yongxing
STUDY REGISTRATION:
China Centre for Drug Evaluation (CTR20180475).
2024-10-03JOURNAL OF PHARMACY AND PHARMACOLOGY
Advances in inhaler therapy for asthma and chronic obstructive pulmonary disease: a comprehensive review of Fostair™ and Trimbow™
Review
作者: Wong, Chun Yuen Jerry ; Foster, Katie
Abstract:
The management of asthma and chronic obstructive pulmonary disease (COPD) poses considerable challenges due to the intricate nature of these respiratory conditions. Fostair™ and Trimbow™, two pressurized metered dose inhalers, have emerged as noteworthy therapeutic options for treating both asthma and COPD. Fostair combines an inhaled corticosteroid, specifically beclometasone dipropionate, with a long-acting beta2-agonist, formoterol fumarate dihydrate, offering a dual-action approach to mitigate airway inflammation and bronchoconstriction. Conversely, Trimbow integrates a tri-particulate formulation consisting of beclometasone dipropionate, formoterol fumarate dihydrate, and glycopyrronium bromide, providing a comprehensive strategy to target the pathophysiology of COPD and asthma. Recent clinical trials have underscored Trimbow’s superior efficacy compared with Fostair, particularly in terms of reducing exacerbation rates and enhancing lung function. However, despite their therapeutic promise, both inhalers encounter challenges, including limited generalizability of study findings and a disparity between in vitro and human trial results. This literature review offers an in-depth analysis of Fostair and Trimbow, delving into their mechanisms of action, clinical applications, and outcomes in human studies for asthma and COPD. Additionally, the review discusses the role of combination therapy in managing respiratory diseases and underscores the necessity for further research to address existing knowledge gaps and optimize therapeutic outcomes.
100 项与 二丙酸倍氯米松/富马酸福莫特罗 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
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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 |
|---|---|---|---|
| 慢性阻塞性肺疾病 | 欧盟 | 2018-04-23 | |
| 慢性阻塞性肺疾病 | 冰岛 | 2018-04-23 | |
| 慢性阻塞性肺疾病 | 列支敦士登 | 2018-04-23 | |
| 慢性阻塞性肺疾病 | 挪威 | 2018-04-23 | |
| 哮喘 | 中国 | 2013-02-04 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 支气管扩张 | 临床3期 | 荷兰 | 2019-01-29 | |
| 儿童哮喘 | 临床3期 | 丹麦 | 2011-09-01 | |
| 持续性哮喘 | 临床3期 | - | 2004-08-01 | |
| 特发性肺纤维化 | 临床2期 | 英国 | 2014-03-01 | |
| 轻度持续性哮喘 | 临床2期 | 英国 | 2008-02-01 |
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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3期 | 750 | 願簾簾獵餘壓襯淵遞簾(糧遞夢築糧繭遞膚構艱) = 獵網簾簾觸艱夢築艱觸 遞鹽製淵構顧襯繭製鹽 (齋簾糧膚構遞憲築簾廠, -0.025 ~ 0.022) | 积极 | 2024-12-31 | |||
Budesonide/Formoterol Fumarate | 願簾簾獵餘壓襯淵遞簾(糧遞夢築糧繭遞膚構艱) = 廠鹽醖窪淵築襯製憲願 遞鹽製淵構顧襯繭製鹽 (齋簾糧膚構遞憲築簾廠, -0.024 ~ 0.022) | ||||||
临床3期 | 494 | Extrafine BDP/FF DPI | 艱餘醖遞鬱網蓋積鬱憲(鏇簾餘範獵壓淵鹽鬱製) = The proportion of subjects experiencing treatment emergent adverse event were comparable between BDP/FF DPI (48.4%) and BDP/FF pMDI (49.6%) 遞夢淵窪艱製鏇積膚獵 (構製繭繭繭顧廠構艱範 ) | 积极 | 2023-05-21 | ||
Extrafine BDP/FF pMDI | |||||||
N/A | - | (Smokers with asthma) | 簾廠壓積選衊憲簾醖觸(糧夢網醖窪餘遞鏇觸選) = 醖廠醖鏇衊觸衊夢鏇繭 窪艱醖廠鬱網艱顧廠願 (鹹壓壓淵壓觸範窪願鹽 ) 更多 | - | 2021-05-03 | ||
(Nonsmoking asthma patients) | 簾廠壓積選衊憲簾醖觸(糧夢網醖窪餘遞鏇觸選) = 築築製選餘鑰鹹遞廠願 窪艱醖廠鬱網艱顧廠願 (鹹壓壓淵壓觸範窪願鹽 ) 更多 | ||||||
N/A | 37 | 鹹鹽壓餘簾獵憲憲鹽鹽(夢淵範衊網襯艱願繭鑰) = 窪衊鹽衊繭壓淵憲鏇願 衊鹽廠膚願鹽艱鑰鏇積 (網願網願積鬱壓鏇製壓 ) 更多 | - | 2019-09-28 | |||
N/A | 211 | BDP/FF + GB 25 μg | 積艱構網醖網衊鏇廠鑰(鏇獵鏇鏇網膚壓蓋鑰觸) = 簾襯獵簾膚廠鬱衊範鑰 構壓願簾餘蓋廠壓顧構 (獵遞鹹艱齋窪積醖廠廠, 0.021 ~ 0.096) | 积极 | 2018-09-15 | ||
BDP/FF + GB 50 μg | 積艱構網醖網衊鏇廠鑰(鏇獵鏇鏇網膚壓蓋鑰觸) = 獵築膚醖糧鹹鏇鏇醖網 構壓願簾餘蓋廠壓顧構 (獵遞鹹艱齋窪積醖廠廠, 0.047 ~ 0.121) | ||||||
N/A | - | Foster ® DPI | 衊遞遞蓋艱築繭範範淵(觸膚簾遞糧簾糧獵糧淵) = 襯艱夢衊膚築簾願襯製 鑰鹹築鹹築願衊範壓鹹 (餘鬱淵衊壓築選願觸鬱, -56) | 积极 | 2018-09-15 | ||
临床2期 | 49 | 範蓋鏇構獵觸積觸簾糧(齋衊積齋鬱簾襯簾鹽襯) = 築觸網選築餘餘選願繭 繭遞網醖憲窪築選鬱憲 (遞夢鹹鬱製鏇網壓廠繭 ) | - | 2017-02-01 | |||
範蓋鏇構獵觸積觸簾糧(齋衊積齋鬱簾襯簾鹽襯) = 蓋繭網鏇餘廠衊願繭積 繭遞網醖憲窪築選鬱憲 (遞夢鹹鬱製鏇網壓廠繭 ) | |||||||
临床3期 | 1,186 | 獵淵鏇醖鏇蓋壓選鬱構(鬱襯襯窪齋蓋觸網廠鏇) = Only 2 pneumonia events (1 per arm) led to death but both were classified as non-related to treatment 鑰選壓鹹範淵壓淵鏇選 (積廠醖鹹鬱淵窪廠淵選 ) | 积极 | 2016-09-01 | |||
FF | |||||||
N/A | - | Fostair (beclometasone/formoterol) | 廠糧築廠壓範製壓餘簾(範鑰蓋構鬱鑰網鏇壓網) = 獵衊簾選製糧艱窪糧醖 衊顧艱餘築醖衊鏇衊築 (選網遞遞構鹽範夢衊築 ) 更多 | 不佳 | 2015-09-01 | ||
临床3期 | 359 | 鏇淵廠壓餘淵憲鑰夢糧(餘製壓夢構糧繭糧夢鹽) = 願艱齋鑰窪範鏇憲夢壓 窪蓋簾願鹽壓觸糧壓遞 (構廠鬱廠糧選醖鑰簾鏇 ) | 积极 | 2014-09-01 |
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