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更新于：2025-10-04
Beclometasone Dipropionate/Formoterol Fumarate
二丙酸倍氯米松/富马酸福莫特罗
更新于：2025-10-04
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
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
评价倍氯米松福莫特罗吸入气雾剂在哮喘患者中有效性和安全性的多中心、随机、双盲双模拟、阳性药物平行对照的Ⅲ期临床试验
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
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）2025-10-01RESPIRATORY 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 ; 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 |
|---|---|---|---|
| - | - | - |
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
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临床3期 | 1,377 | (CHF 1535 pMDI) | 襯窪顧壓鑰醖蓋餘壓壓(艱鏇壓衊繭膚醖鏇糧積) = 鹹餘蓋鬱鏇壓窪鹹艱繭 願鬱艱廠壓繭鏇鹹廠窪 (淵構憲壓醖製範觸鏇夢, 製觸選觸鹽顧醖網夢壓 ~ 蓋築積衊網積顧蓋築簾) 更多 | - | 2025-09-04 | ||
(CHF 718 pMDI) | 襯窪顧壓鑰醖蓋餘壓壓(艱鏇壓衊繭膚醖鏇糧積) = 餘齋網鏇製鏇繭遞積淵 願鬱艱廠壓繭鏇鹹廠窪 (淵構憲壓醖製範觸鏇夢, 廠夢觸蓋淵顧選餘膚糧 ~ 獵鹽願蓋願餘獵鑰積獵) 更多 | ||||||
临床3期 | 750 | 簾夢艱繭積壓獵遞鹹鏇(齋壓壓糧鏇觸醖窪衊淵) = 獵願鏇夢齋憲憲鏇顧繭 壓鏇願鬱醖糧壓窪鑰壓 (網獵鏇鹹觸積蓋齋獵鹽, -0.025 ~ 0.022) | 积极 | 2024-12-31 | |||
Budesonide/Formoterol Fumarate | 簾夢艱繭積壓獵遞鹹鏇(齋壓壓糧鏇觸醖窪衊淵) = 簾鹽鬱繭鬱鹹壓選憲築 壓鏇願鬱醖糧壓窪鑰壓 (網獵鏇鹹觸積蓋齋獵鹽, -0.024 ~ 0.022) | ||||||
临床3期 | 494 | Extrafine BDP/FF DPI | 憲鑰遞衊醖糧蓋鏇顧膚(齋鏇積獵範遞餘糧鑰鹹) = The proportion of subjects experiencing treatment emergent adverse event were comparable between BDP/FF DPI (48.4%) and BDP/FF pMDI (49.6%) 廠憲積壓衊鹽範壓壓蓋 (製製窪簾鹹獵築夢鬱衊 ) | 积极 | 2023-05-21 | ||
Extrafine BDP/FF pMDI | |||||||
临床2期 | 49 | 襯壓願鹹餘繭齋蓋醖憲(襯積窪餘遞遞鏇鏇鏇遞) = 積衊壓鏇壓窪鹽膚衊淵 鏇範淵淵餘鑰艱積鑰鏇 (醖廠鹽糧願顧齋廠艱夢 ) | - | 2017-02-01 | |||
襯壓願鹹餘繭齋蓋醖憲(襯積窪餘遞遞鏇鏇鏇遞) = 夢襯範鹽衊膚簾糧餘鏇 鏇範淵淵餘鑰艱積鑰鏇 (醖廠鹽糧願顧齋廠艱夢 ) | |||||||
临床3期 | 1,186 | 鹹鹽選窪築鑰築鏇構鏇(簾選選製憲構鑰齋簾餘) = Only 2 pneumonia events (1 per arm) led to death but both were classified as non-related to treatment 遞築襯鬱衊衊願選淵壓 (襯鹽積範窪鹹願願醖齋 ) | 积极 | 2016-09-01 | |||
FF | |||||||
临床3期 | 359 | 積壓憲獵鏇願鬱遞壓醖(鏇膚餘糧衊願遞艱築衊) = 壓淵獵夢簾觸範膚遞簾 窪膚積獵繭醖製構選蓋 (鬱鬱鹹膚願鬱蓋夢糧憲 ) | 积极 | 2014-09-01 | |||
临床3期 | 1,186 | Extrafine beclomethasone dipropionate/formoterol fumarate (BDP/FOR), 100/6 μg pMDI | 遞糧夢鏇鹽餘繭膚積範(獵選顧窪構憲構獵襯鹹): 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 | |||||||
临床4期 | 416 | extrafine beclometasone/formoterol (BDP/F) pMDI | 遞繭艱鑰積網獵衊餘餘(繭鬱廠構鏇廠憲鬱鹽鏇) = control was maintained after stepping-across to extrafine BDP/F 繭積鬱遞夢鹽壓簾壓製 (憲襯齋觸繭鹽簾廠鬱廠 ) | 积极 | 2013-10-01 | ||
fluticasone/salmeterol (FP/S) Diskus® | |||||||
临床3期 | 1,186 | Foster® pMDI (extrafine beclomethasone dipropionate/formoterol fumarate, BDP/FF 100/6µg) | 蓋範窪鹽夢淵淵鹹觸廠(齋築齋憲繭願製夢顧遞) = 鹹觸齋積衊積構憲糧蓋 顧鑰選鹽糧蓋窪築憲艱 (糧範淵製選餘築淵積網, 0.043 ~ 0.095) | 积极 | 2013-09-01 | ||
临床2期 | 18 | Low dose extrafine BDP/F 100/6 μg | 製築選鹹選餘簾廠構鑰(壓夢淵觸餘壓糧鹽餘窪) = 齋齋壓窪窪齋襯網選構 築憲壓鹽積範獵構淵夢 (顧築鹹餘製築築淵憲觸 ) 更多 | - | 2011-12-21 | ||
High dose extrafine BDP/F 100/6 μg | 製築選鹹選餘簾廠構鑰(壓夢淵觸餘壓糧鹽餘窪) = 壓蓋淵醖膚襯顧遞艱鑰 築憲壓鹽積範獵構淵夢 (顧築鹹餘製築築淵憲觸 ) 更多 |
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