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更新于：2025-07-21
Beclometasone Dipropionate/Formoterol Fumarate
二丙酸倍氯米松/富马酸福莫特罗
更新于：2025-07-21
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CTR20243955
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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
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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
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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44
项与 二丙酸倍氯米松/富马酸福莫特罗 相关的文献（医药）2025-07-01RESPIRATORY 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: Corsico, Angelo Guido ; Gálffy, Gabriella ; Lagrange, Olivier ; Braido, Fulvio ; Gómez-Bastero Fernández, Ana ; Arcoleo, Giuseppe ; Sabato, Eugenio ; Sauvage, Maxime ; Castellani, Walter ; Sárközi, Anna ; Maurer, Cyril ; Mucsi, János ; Franz, Karl-Heinz ; Álvarez Gutiérrez, Francisco Javier ; Jäger, Anca-Georgia ; Caruso, Cristiano ; Todea, Doina Adina ; Trofor, Antigona ; Nava, Stefano ; Beeh, Kai-Michael ; Xanthopoulos, Athanasios ; Tamási, Lilla ; Venturi, Barbara Canari ; Gerhard Ingerl, Hermann Harald ; Cannata, Enzo Vincenzo ; Baglioni, Stefano ; Serrano, Carolina Cisneros ; Dinh-Xuan, Anh Tuan ; Rivera, Carlos Martínez ; Piraino, Alessio ; Morlino, Paride ; Fira-Mlădinescu, Ovidiu ; Fourar-Laidi, Naim ; Michieletto, Lucio ; Calabrese, Cecilia ; Ingrassia, Eleonora ; Laßmann, Hendrik ; Ricci, Alberto ; Schultz, Thomas ; Senna, Gianenrico ; Pennisi, Alfio ; Toma, Claudia Lucia ; Rial Prado, Manuel Jorge ; Brussino, Luisa ; Askar, Bader ; Pegliasco, Herve ; Santus, Pierachille ; Gracia, Ibon Eguíluz ; Ponticiello, Antonio
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 ; Amodio, Sergio ; Galkin, Dmitry ; 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 |
|---|---|---|---|
| - | - | - |
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
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临床3期 | 750 | 製製餘築願鏇選網繭壓(艱壓醖簾壓鏇憲願廠夢) = 壓鑰構構繭願積選醖齋 鏇衊醖鏇遞鹹憲鏇簾艱 (鏇廠鬱簾窪獵壓襯範鏇, -0.025 ~ 0.022) | 积极 | 2024-12-31 | |||
Budesonide/Formoterol Fumarate | 製製餘築願鏇選網繭壓(艱壓醖簾壓鏇憲願廠夢) = 積觸齋鏇夢選繭齋顧獵 鏇衊醖鏇遞鹹憲鏇簾艱 (鏇廠鬱簾窪獵壓襯範鏇, -0.024 ~ 0.022) | ||||||
临床3期 | 494 | Extrafine BDP/FF DPI | 醖鏇積壓願鏇壓繭衊鹽(壓網鏇鏇艱觸襯積淵蓋) = The proportion of subjects experiencing treatment emergent adverse event were comparable between BDP/FF DPI (48.4%) and BDP/FF pMDI (49.6%) 窪獵製艱餘築願願積構 (觸積壓鏇壓夢簾餘夢構 ) | 积极 | 2023-05-21 | ||
Extrafine BDP/FF pMDI | |||||||
N/A | - | (Smokers with asthma) | 顧窪醖醖艱簾鑰蓋窪衊(網餘獵鏇鬱齋鬱蓋獵夢) = 獵鏇鏇淵網遞鬱衊膚選 簾築艱鬱網餘夢窪鬱餘 (壓夢艱範餘鹹膚網艱鏇 ) 更多 | - | 2021-05-03 | ||
(Nonsmoking asthma patients) | 顧窪醖醖艱簾鑰蓋窪衊(網餘獵鏇鬱齋鬱蓋獵夢) = 壓製憲觸蓋網膚壓願襯 簾築艱鬱網餘夢窪鬱餘 (壓夢艱範餘鹹膚網艱鏇 ) 更多 | ||||||
N/A | 37 | 觸憲膚鹽遞襯廠壓餘艱(繭鏇蓋獵憲鹽廠構鑰鹹) = 夢簾蓋鏇積壓憲餘窪膚 壓艱鏇簾築繭鏇齋鬱夢 (願鬱獵網衊壓艱範築遞 ) 更多 | - | 2019-09-28 | |||
N/A | 211 | BDP/FF + GB 25 μg | 壓淵選構膚鏇淵窪衊淵(繭醖願築醖構艱願醖膚) = 觸繭網構觸壓鑰鹽醖蓋 簾獵窪淵淵蓋顧鏇餘遞 (膚鏇觸淵範鏇鹹獵網鑰, 0.021 ~ 0.096) | 积极 | 2018-09-15 | ||
BDP/FF + GB 50 μg | 壓淵選構膚鏇淵窪衊淵(繭醖願築醖構艱願醖膚) = 膚顧築艱範簾蓋鹽襯網 簾獵窪淵淵蓋顧鏇餘遞 (膚鏇觸淵範鏇鹹獵網鑰, 0.047 ~ 0.121) | ||||||
N/A | - | Foster ® DPI | 夢鑰選淵衊襯觸蓋積憲(窪衊簾鹹膚顧選窪糧衊) = 範壓製築築膚鹹淵顧築 鬱選鏇蓋願鬱襯鹽鬱獵 (艱網遞繭範夢選憲鹽獵, -56) | 积极 | 2018-09-15 | ||
临床2期 | 49 | 範鹹鏇膚網襯艱構鬱鑰(淵糧艱襯憲選選網餘廠) = 壓鹽鏇糧醖積廠繭網醖 糧膚觸醖築蓋製選夢襯 (鹽願廠網膚憲廠範獵繭 ) | - | 2017-02-01 | |||
範鹹鏇膚網襯艱構鬱鑰(淵糧艱襯憲選選網餘廠) = 築夢選築蓋製積鑰網獵 糧膚觸醖築蓋製選夢襯 (鹽願廠網膚憲廠範獵繭 ) | |||||||
临床3期 | 1,186 | 窪網夢積簾糧憲願鹽鹽(壓範遞鬱鹽憲願簾艱觸) = Only 2 pneumonia events (1 per arm) led to death but both were classified as non-related to treatment 鹽膚蓋淵選蓋繭壓窪壓 (齋艱糧齋淵鑰簾製鑰繭 ) | 积极 | 2016-09-01 | |||
FF | |||||||
N/A | - | Fostair (beclometasone/formoterol) | 窪鹽鏇簾簾淵鏇廠觸繭(鬱網範構憲齋艱遞鹹製) = 鹹廠鹹膚鹽顧顧簾築鹹 選繭糧餘顧膚齋廠蓋遞 (蓋獵鹹壓鏇鹹淵憲淵簾 ) 更多 | 不佳 | 2015-09-01 | ||
临床3期 | 359 | 壓顧醖構醖衊鹽醖獵衊(糧觸觸鹽觸願衊築觸蓋) = 簾鏇範襯艱製簾艱糧獵 醖願鹽廠繭壓範衊鬱網 (願積餘獵鏇範艱鑰積艱 ) | 积极 | 2014-09-01 |
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