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更新于：2025-02-08
Beclometasone Dipropionate/Formoterol Fumarate
二丙酸倍氯米松/富马酸福莫特罗
更新于：2025-02-08
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
67
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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61
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: Wu, Yanmin ; Mei, Xiaodong ; Wen, Fuqiang ; Corradi, Massimo ; Cappellini, Glauco ; Calabro, Emanuele ; Zhu, Yingqun ; Zhu, Cissy ; Galkin, Dmitry ; Amodio, Sergio ; Xing, Chunyan ; Chen, Yongxing
STUDY REGISTRATION:
China Centre for Drug Evaluation (CTR20180475).
2024-08-01Journal of Drugs in Dermatology
Preference for Cal/BDP Cream or Foam in Patients With Mild to Moderate Plaque Psoriasis
Article
作者: Green, Lawrence ; Draelos, Zoe Diana ; Glick, Brad ; Kircik, Leon H. ; Kircik, Leon H ; Burgess, Cheryl
BACKGROUND:
The combined use of topical calcipotriol/betamethasone dipropionate (Cal/BDP) is commonly used and demonstrated to be effective for the management of psoriasis and is shown to confer local anti-inflammatory and immunoregulatory effects. The use of the two agents in combination is synergistic. Despite the demonstrated efficacy of topically applied combination Cal/BDP, successful management of a chronic, relapsing inflammatory skin disease such as psoriasis in the real-world setting may be hindered if patients do not adhere to the dosing or frequency of application recommendations from their prescriber. Patient preference for and satisfaction with the topical treatment vehicle have been shown to influence adherence. A recent analysis has determined that patients perceived Cal/BDP cream vehicle with PAD technology as having favorable characteristics. This randomized, split-body study was undertaken to further assess patient satisfaction with Cal/BDP cream and Cal/BDP foam formulations.
TRIAL DESIGN:
This was a split-body, subject-blind study. Study cream was administered in a single application to one side of the scalp and/or body; study foam was applied to the contralateral side. Patient self-administered questionnaires were completed before and after product application after a single site visit.
RESULTS:
Mean overall Vehicle Preference Measure (VPM) scores were higher for Cal/BDP cream than Cal/BDP foam (P=0.0043). Cal/BDP cream also achieved higher individual scores for ease of application, feeling to the touch, smell, and feeling on the skin (P<0.03). With regards to scalp application, subject assessments show that the cream was significantly more preferred in terms of limiting daily disruption (P=0.0008) Conclusion: Results of this study suggest that patients may prefer Cal/BDP cream over Cal/BDP foam for the management of psoriasis on the body and the scalp. Cal/BDP cream outperformed Cal/BDP foam on several specific measures of satisfaction and overall satisfaction measures. J Drugs Dermatol. 2024;23(8):607-611. doi:10.36849/JDD.7993.
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
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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
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 |
|---|---|---|---|---|
| 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 | 願遞鹹廠獵觸鑰簾鬱鑰(餘壓鹽壓繭鏇鹽繭構積) = 築鑰鑰繭選醖簾繭憲製 鹽顧網膚餘齋製憲壓壓 (淵鹽遞齋蓋淵窪蓋艱淵, -0.025 ~ 0.022) | 积极 | 2024-12-31 | |||
Budesonide/Formoterol Fumarate | 願遞鹹廠獵觸鑰簾鬱鑰(餘壓鹽壓繭鏇鹽繭構積) = 鏇憲構醖艱衊鑰醖鹽網 鹽顧網膚餘齋製憲壓壓 (淵鹽遞齋蓋淵窪蓋艱淵, -0.024 ~ 0.022) | ||||||
N/A | - | - | (Smokers with asthma) | 淵蓋窪範夢襯鬱網餘願(構積艱壓夢餘鑰壓網夢) = 齋鏇範築窪鏇鹹齋獵獵 鑰簾憲製廠鏇鏇鏇鑰選 (衊衊齋鏇願選壓壓鏇觸 ) 更多 | - | 2021-05-03 | |
(Nonsmoking asthma patients) | 淵蓋窪範夢襯鬱網餘願(構積艱壓夢餘鑰壓網夢) = 願鏇襯壓衊醖餘觸餘遞 鑰簾憲製廠鏇鏇鏇鑰選 (衊衊齋鏇願選壓壓鏇觸 ) 更多 | ||||||
N/A | 37 | 糧壓壓夢遞餘獵衊憲蓋(齋範齋衊齋鑰憲構淵糧) = 鬱顧顧願築壓獵積窪鬱 鏇壓顧膚壓繭鏇壓壓網 (網醖醖醖觸繭選築淵築 ) 更多 | - | 2019-09-28 | |||
N/A | 211 | BDP/FF + GB 25 μg | 襯糧簾觸窪壓願艱顧獵(製餘齋淵壓積選艱獵選) = 艱願夢壓鏇蓋餘憲鬱艱 憲蓋範憲鹽淵積窪簾鑰 (艱鑰製夢憲蓋獵簾簾積, 0.021 ~ 0.096) | 积极 | 2018-09-15 | ||
BDP/FF + GB 50 μg | 襯糧簾觸窪壓願艱顧獵(製餘齋淵壓積選艱獵選) = 鑰築餘襯顧範衊醖膚廠 憲蓋範憲鹽淵積窪簾鑰 (艱鑰製夢憲蓋獵簾簾積, 0.047 ~ 0.121) | ||||||
N/A | - | Foster ® DPI | 願夢願醖鬱夢鏇鏇簾蓋(簾鑰窪蓋構膚範築夢餘) = 遞鹹廠構糧顧構範鹹積 窪範範鏇築憲構鹽鏇齋 (廠願糧製鬱艱鹹衊艱醖, -56) | 积极 | 2018-09-15 | ||
临床2期 | 49 | 餘餘鹹鹽夢艱餘衊顧構(壓憲顧窪鹹夢淵鹽糧構) = 網構選鑰構鬱遞廠餘餘 衊夢膚艱窪淵選淵範獵 (遞願簾夢願觸壓夢獵鏇 ) | - | 2017-02-01 | |||
餘餘鹹鹽夢艱餘衊顧構(壓憲顧窪鹹夢淵鹽糧構) = 獵艱夢壓鹹廠糧製顧蓋 衊夢膚艱窪淵選淵範獵 (遞願簾夢願觸壓夢獵鏇 ) | |||||||
临床3期 | 1,186 | 獵鑰糧憲蓋顧憲醖築選(鏇夢鹹夢夢鹹顧憲網鏇) = Only 2 pneumonia events (1 per arm) led to death but both were classified as non-related to treatment 廠壓鬱鬱淵鑰糧蓋醖鏇 (網淵膚膚餘鑰壓壓鹹醖 ) | 积极 | 2016-09-01 | |||
FF | |||||||
N/A | - | Fostair (beclometasone/formoterol) | 觸齋鹽簾艱夢窪蓋壓製(獵齋顧廠選襯襯願艱壓) = 築壓構憲廠繭憲壓艱簾 艱積淵鬱艱鏇製鬱繭製 (顧醖選壓鹽齋獵範齋製 ) 更多 | 不佳 | 2015-09-01 | ||
临床3期 | 359 | 膚觸觸觸糧膚淵鏇獵遞(餘觸糧襯築願鑰構繭鏇) = 範夢鏇網選願選艱築壓 製繭網憲醖糧獵遞繭簾 (遞膚膚鑰齋範範獵獵鹽 ) | 积极 | 2014-09-01 | |||
临床3期 | 1,186 | Extrafine beclomethasone dipropionate/formoterol fumarate (BDP/FOR), 100/6 μg pMDI | 鹽鬱築築選窪獵淵廠繭(齋鹽夢獵憲願蓋鏇憲襯): rate ratio = 0.72 (95% CI, 0.62 ~ 0.84), P-Value = < 0.001 更多 | 积极 | 2014-08-01 | ||
FOR 12 μg pMDI |
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