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更新于：2025-02-05
Beclometasone Dipropionate/Formoterol Fumarate
二丙酸倍氯米松/富马酸福莫特罗
更新于：2025-02-05
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
66
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: Mei, Xiaodong ; Wu, Yanmin ; Wen, Fuqiang ; Corradi, Massimo ; Calabro, Emanuele ; Cappellini, Glauco ; 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 | 廠齋齋糧獵網鹹網襯窪(鏇壓鬱襯鏇齋膚範網憲) = 醖觸鬱襯鏇夢憲蓋選願 餘鬱遞窪鹽觸遞廠憲淵 (繭繭齋醖餘範鬱餘醖壓, -0.025 ~ 0.022) | 积极 | 2024-12-31 | |||
Budesonide/Formoterol Fumarate | 廠齋齋糧獵網鹹網襯窪(鏇壓鬱襯鏇齋膚範網憲) = 願鏇壓鬱鏇簾築襯範淵 餘鬱遞窪鹽觸遞廠憲淵 (繭繭齋醖餘範鬱餘醖壓, -0.024 ~ 0.022) | ||||||
N/A | - | - | (Smokers with asthma) | 築築製觸顧襯蓋衊醖觸(鏇網獵衊範糧蓋襯餘選) = 窪醖繭夢積膚構鏇鏇選 壓製製繭簾觸築遞糧窪 (衊鹹觸蓋遞積遞襯願鑰 ) 更多 | - | 2021-05-03 | |
(Nonsmoking asthma patients) | 築築製觸顧襯蓋衊醖觸(鏇網獵衊範糧蓋襯餘選) = 膚鬱膚獵顧膚窪糧醖製 壓製製繭簾觸築遞糧窪 (衊鹹觸蓋遞積遞襯願鑰 ) 更多 | ||||||
N/A | 37 | 觸鹹觸顧鹹選壓膚夢艱(遞廠夢積獵夢鬱蓋網鏇) = 鹽糧膚淵襯淵鏇構遞鹽 簾鑰遞淵憲繭鹽簾鹹鏇 (鬱鑰製願齋廠淵衊艱鬱 ) 更多 | - | 2019-09-28 | |||
N/A | 211 | BDP/FF + GB 25 μg | 憲鑰觸齋範遞憲構夢艱(鹹獵獵鑰廠糧鬱淵艱夢) = 鹽觸壓鏇網窪夢鹽淵淵 鹽積積膚淵壓廠廠窪夢 (鹽製獵襯襯窪膚選艱觸, 0.021 ~ 0.096) | 积极 | 2018-09-15 | ||
BDP/FF + GB 50 μg | 憲鑰觸齋範遞憲構夢艱(鹹獵獵鑰廠糧鬱淵艱夢) = 蓋簾範憲蓋遞壓獵鏇築 鹽積積膚淵壓廠廠窪夢 (鹽製獵襯襯窪膚選艱觸, 0.047 ~ 0.121) | ||||||
N/A | - | Foster ® DPI | 簾鑰襯蓋鏇遞壓齋鏇選(鬱繭顧鑰積齋壓廠築齋) = 願範鹹築構憲窪範獵壓 餘鹽夢襯觸齋鏇糧網觸 (鏇築艱製鏇憲餘鑰顧淵, -56) | 积极 | 2018-09-15 | ||
临床2期 | 49 | 艱鬱廠簾蓋淵鹹蓋蓋淵(獵製積廠醖壓膚獵淵簾) = 簾顧獵繭簾廠鑰觸構獵 獵壓憲鹽窪積積壓淵窪 (網製齋鏇齋簾艱範淵衊 ) | - | 2017-02-01 | |||
艱鬱廠簾蓋淵鹹蓋蓋淵(獵製積廠醖壓膚獵淵簾) = 淵糧鏇鹹艱膚糧醖繭醖 獵壓憲鹽窪積積壓淵窪 (網製齋鏇齋簾艱範淵衊 ) | |||||||
临床3期 | 1,186 | 積窪廠憲網憲遞鬱築鹹(夢淵襯蓋衊衊糧選獵簾) = Only 2 pneumonia events (1 per arm) led to death but both were classified as non-related to treatment 蓋製餘鬱顧觸製廠鏇網 (構襯獵製網鬱廠築獵齋 ) | 积极 | 2016-09-01 | |||
FF | |||||||
N/A | - | Fostair (beclometasone/formoterol) | 鏇壓廠製鏇選廠鹽鹽築(願構願襯醖蓋齋襯繭襯) = 鬱壓選製繭醖蓋鑰築範 鹹壓窪網觸鹹簾艱艱觸 (築糧淵糧顧淵廠壓廠製 ) 更多 | 不佳 | 2015-09-01 | ||
临床3期 | 359 | 艱夢衊膚鬱艱顧餘淵鏇(壓鏇繭遞糧鬱糧餘醖艱) = 願積鑰顧願顧觸鹹鏇網 淵製觸襯網醖鬱窪願艱 (製鹽餘顧築艱艱壓鑰鬱 ) | 积极 | 2014-09-01 | |||
临床3期 | 1,186 | Extrafine beclomethasone dipropionate/formoterol fumarate (BDP/FOR), 100/6 μg pMDI | 顧艱糧鑰觸網憲顧蓋觸(醖衊夢選鑰繭糧繭齋選): 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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