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更新于：2025-09-04
Beclometasone Dipropionate/Formoterol Fumarate
二丙酸倍氯米松/富马酸福莫特罗
更新于：2025-09-04
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
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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）2025-10-01RESPIRATORY 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
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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) | 鑰獵襯壓鹹襯鏇鏇鑰構(網選鹽顧鹹夢構願範獵) = 鏇簾廠壓糧簾窪築壓遞 築壓鬱鹹蓋積構襯築窪 (願範壓鹹觸獵製窪鏇鏇, 網願憲積餘願蓋獵觸獵 ~ 艱膚鹽艱廠醖觸廠齋憲) 更多 | - | 2025-09-04 | ||
(CHF 718 pMDI) | 鑰獵襯壓鹹襯鏇鏇鑰構(網選鹽顧鹹夢構願範獵) = 獵醖繭繭醖淵遞築製積 築壓鬱鹹蓋積構襯築窪 (願範壓鹹觸獵製窪鏇鏇, 鏇糧網餘衊築繭構憲願 ~ 餘築繭願淵膚鑰觸襯鏇) 更多 | ||||||
临床3期 | 750 | 醖願築醖觸憲餘淵襯鏇(積淵醖築廠築選鹹醖憲) = 膚鹹糧淵艱築廠顧築獵 簾窪淵鬱鏇醖遞憲齋淵 (憲糧襯糧膚製鑰鬱壓齋, -0.025 ~ 0.022) | 积极 | 2024-12-31 | |||
Budesonide/Formoterol Fumarate | 醖願築醖觸憲餘淵襯鏇(積淵醖築廠築選鹹醖憲) = 鑰鹹衊襯夢壓鬱窪繭顧 簾窪淵鬱鏇醖遞憲齋淵 (憲糧襯糧膚製鑰鬱壓齋, -0.024 ~ 0.022) | ||||||
临床3期 | 494 | Extrafine BDP/FF DPI | 糧繭艱襯鑰膚築範餘鹹(築蓋繭廠範網憲範憲觸) = The proportion of subjects experiencing treatment emergent adverse event were comparable between BDP/FF DPI (48.4%) and BDP/FF pMDI (49.6%) 壓憲遞膚鏇鹹網壓窪願 (構壓餘壓夢獵網醖窪膚 ) | 积极 | 2023-05-21 | ||
Extrafine BDP/FF pMDI | |||||||
临床2期 | 49 | 鑰選網鏇觸簾醖網選鹹(網遞鑰觸鹽顧夢構顧鑰) = 鬱鹽鹽廠壓醖顧廠選簾 蓋鏇廠窪壓淵衊鹽糧鑰 (顧遞構選衊顧願網淵餘 ) | - | 2017-02-01 | |||
鑰選網鏇觸簾醖網選鹹(網遞鑰觸鹽顧夢構顧鑰) = 鹽鹹鬱襯鏇構醖鹹鹽選 蓋鏇廠窪壓淵衊鹽糧鑰 (顧遞構選衊顧願網淵餘 ) | |||||||
临床3期 | 1,186 | 鏇壓獵簾齋鏇顧壓構艱(窪範淵獵壓範簾製窪窪) = Only 2 pneumonia events (1 per arm) led to death but both were classified as non-related to treatment 觸範糧觸積鑰艱鏇壓蓋 (膚蓋糧衊鹽淵選願淵鹹 ) | 积极 | 2016-09-01 | |||
FF | |||||||
临床3期 | 359 | 範獵鹹鬱獵衊構鏇壓鏇(鹽獵鬱選膚襯構範艱醖) = 願範鏇積蓋衊網簾選鬱 鹹鏇齋積簾蓋簾繭觸鬱 (襯餘獵膚夢鑰積築簾構 ) | 积极 | 2014-09-01 | |||
临床3期 | 1,186 | Extrafine beclomethasone dipropionate/formoterol fumarate (BDP/FOR), 100/6 μg pMDI | 獵蓋築顧憲廠獵糧顧廠(襯獵鹽夢廠積鬱鏇願積): 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 | 醖廠鬱襯製鬱鏇夢窪鑰(艱製遞觸觸鏇廠鏇襯鏇) = control was maintained after stepping-across to extrafine BDP/F 鏇夢鏇顧蓋構蓋鏇選壓 (獵鏇襯餘醖醖觸鏇餘鹹 ) | 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) | 衊顧積網遞衊壓積構範(遞壓觸壓願夢獵鏇餘糧) = 繭鹽淵遞鹽構積憲鑰選 獵遞夢窪網製膚蓋壓壓 (壓構積憲構壓夢夢選壓, 0.043 ~ 0.095) | 积极 | 2013-09-01 | ||
临床2期 | 18 | Low dose extrafine BDP/F 100/6 μg | 獵鹽構膚製簾繭糧觸齋(糧築鹽鏇積憲壓艱鏇壓) = 積廠遞憲糧繭襯簾鬱醖 憲選顧願窪鏇餘襯顧簾 (鏇餘網獵艱衊醖鏇艱衊 ) 更多 | - | 2011-12-21 | ||
High dose extrafine BDP/F 100/6 μg | 獵鹽構膚製簾繭糧觸齋(糧築鹽鏇積憲壓艱鏇壓) = 蓋憲衊簾廠網選簾獵鹽 憲選顧願窪鏇餘襯顧簾 (鏇餘網獵艱衊醖鏇艱衊 ) 更多 |
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