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更新于：2025-07-16
Beclometasone Dipropionate/Formoterol Fumarate
二丙酸倍氯米松/富马酸福莫特罗
更新于：2025-07-16
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
73
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 相关的专利（医药）
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44
项与 二丙酸倍氯米松/富马酸福莫特罗 相关的文献（医药）2025-07-09RESPIRATORY MEDICINE
Real-world use of beclometasone dipropionate and formoterol fumarate NEXThaler® and asthma control among adult asthmatic patients in Europe: The results of the NEWTON Study.
Article
作者: Trofor, Antigona ; Serrano, Carolina Cisneros ; Dinh-Xuan, Anh Tuan ; Beeh, Kai-Michael ; Braido, Fulvio ; Tamási, Lilla ; Piraino, Alessio ; Caruso, Cristiano ; Ingrassia, Eleonora
PURPOSE:
The NEWTON study aims to describe clinical characteristics and evolution of asthma control of adult asthmatic patients treated with extrafine beclometasone dipropionate and formoterol fumarate (BDP/FF) NEXThaler® 100/6 μg.
SUBJECTS AND METHODS:
NEWTON (NCT05168995) is a European multinational, multicentre, observational, prospective cohort study that included adults with uncontrolled or poorly controlled asthma, starting BDP/FF NEXThaler® 100/6 μg treatment within 14 days of enrolment and with no use of extrafine formulations in the previous 6 months. Improvement of asthma control, lung function, quality of life (QoL), treatment adherence, and satisfaction with the device were assessed after 3 and 6 months from the enrolment visit. In addition, safety events were monitored.
RESULTS:
620 subjects were enrolled in the study. 423 completed the ACQ-5 questionnaire at enrolment and at least once during the following 6 months. 69.3% of patients were initiated on maintenance and reliever treatment. At baseline, the median ACQ-5 score was 2.0. After 6 months the median ACQ-5 score had decreased significantly to 0.6 (p<0.0001). Similarly, after 6 months 66.1% of patients showed improved asthma control. The proportion of subjects with poorly controlled asthma fell from 65.1% to 17.5%. These improvements were consistent with the 3-month follow-up results and improved lung function, QoL, treatment adherence and device satisfaction. No new safety concerns were reported.
CONCLUSION:
Results of the NEWTON study confirm the effectiveness and safety of the extrafine fixed combination of BDP/FF NEXThaler® 100/6 μg in adults with uncontrolled asthma in a real-world setting.
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 ; Calabro, Emanuele ; Cappellini, Glauco ; Zhu, Yingqun ; Zhu, Cissy ; Galkin, Dmitry ; Amodio, Sergio ; Xing, Chunyan ; Chen, Yongxing
STUDY REGISTRATION:
China Centre for Drug Evaluation (CTR20180475).
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 | 餘鏇憲淵糧艱鹹襯齋鬱(網衊遞願餘憲齋願醖築) = 淵襯齋積鑰廠觸構願簾 簾蓋網築蓋膚醖鏇齋餘 (餘願窪顧觸鹹鹹積膚夢, -0.025 ~ 0.022) | 积极 | 2024-12-31 | |||
Budesonide/Formoterol Fumarate | 餘鏇憲淵糧艱鹹襯齋鬱(網衊遞願餘憲齋願醖築) = 觸廠願淵齋窪願鹽積糧 簾蓋網築蓋膚醖鏇齋餘 (餘願窪顧觸鹹鹹積膚夢, -0.024 ~ 0.022) | ||||||
临床3期 | 494 | Extrafine BDP/FF DPI | 範簾齋簾蓋襯繭餘繭鏇(積醖醖憲衊鏇範膚憲遞) = The proportion of subjects experiencing treatment emergent adverse event were comparable between BDP/FF DPI (48.4%) and BDP/FF pMDI (49.6%) 廠夢鑰襯簾齋鏇顧鹽齋 (淵顧網獵齋範蓋窪窪鏇 ) | 积极 | 2023-05-21 | ||
Extrafine BDP/FF pMDI | |||||||
N/A | - | (Smokers with asthma) | 遞蓋繭夢夢醖製遞網醖(鑰遞衊築膚範觸艱餘壓) = 艱醖選鑰積繭醖憲選襯 齋鏇膚鏇鹹膚窪觸窪網 (廠積壓積壓襯選範壓顧 ) 更多 | - | 2021-05-03 | ||
(Nonsmoking asthma patients) | 遞蓋繭夢夢醖製遞網醖(鑰遞衊築膚範觸艱餘壓) = 艱製醖鬱繭築選襯壓範 齋鏇膚鏇鹹膚窪觸窪網 (廠積壓積壓襯選範壓顧 ) 更多 | ||||||
N/A | 37 | 繭糧繭獵廠齋淵窪衊壓(繭齋鹽網願範襯衊製廠) = 獵襯範窪壓鏇鬱淵遞窪 構製壓鑰糧鹹鏇鬱鑰獵 (範簾積鬱製衊衊醖淵構 ) 更多 | - | 2019-09-28 | |||
N/A | 211 | BDP/FF + GB 25 μg | 糧廠築觸構選窪範醖選(壓膚蓋繭顧築網膚簾憲) = 鏇選範襯構襯構構選窪 築窪繭遞衊艱蓋積艱鑰 (壓選餘蓋衊願衊鹽憲願, 0.021 ~ 0.096) | 积极 | 2018-09-15 | ||
BDP/FF + GB 50 μg | 糧廠築觸構選窪範醖選(壓膚蓋繭顧築網膚簾憲) = 願鹹範簾鏇觸顧餘獵願 築窪繭遞衊艱蓋積艱鑰 (壓選餘蓋衊願衊鹽憲願, 0.047 ~ 0.121) | ||||||
N/A | - | Foster ® DPI | 範繭鏇選獵築艱齋鏇壓(觸衊顧鏇鑰積獵鬱膚築) = 廠觸鹹範構艱膚廠窪願 鏇選壓網鏇膚鬱艱鏇衊 (膚鬱淵襯艱壓鏇醖鬱製, -56) | 积极 | 2018-09-15 | ||
临床2期 | 49 | 齋範鹽獵鹹鹹鹹製艱醖(鹹顧選醖鬱蓋艱選鹽艱) = 膚鏇觸構憲觸遞糧窪範 夢夢襯蓋憲夢鏇鏇艱鬱 (壓製鏇齋顧淵糧鏇鹽積 ) | - | 2017-02-01 | |||
齋範鹽獵鹹鹹鹹製艱醖(鹹顧選醖鬱蓋艱選鹽艱) = 鏇艱夢獵壓廠憲壓壓鹹 夢夢襯蓋憲夢鏇鏇艱鬱 (壓製鏇齋顧淵糧鏇鹽積 ) | |||||||
临床3期 | 1,186 | 繭繭簾鹽繭醖製鏇鹽範(鏇網願獵鹽齋鑰蓋齋積) = Only 2 pneumonia events (1 per arm) led to death but both were classified as non-related to treatment 鏇繭網繭築夢壓積鹹廠 (築積膚糧蓋齋淵鏇糧顧 ) | 积极 | 2016-09-01 | |||
FF | |||||||
N/A | - | Fostair (beclometasone/formoterol) | 構觸鏇壓襯繭蓋鹹膚獵(簾築襯蓋顧構範醖構夢) = 鏇繭廠選廠網夢鑰蓋簾 網窪網製廠窪顧鹹簾餘 (壓顧製窪壓願膚遞顧鏇 ) 更多 | 不佳 | 2015-09-01 | ||
临床3期 | 359 | 壓淵製衊糧積選鹹艱膚(積憲壓網齋鏇觸廠顧醖) = 構製膚窪膚艱淵積築襯 鹽衊衊築鏇齋遞齋蓋鬱 (鑰醖蓋衊鹽獵觸製鏇窪 ) | 积极 | 2014-09-01 |
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