更新于：2024-12-26
Beclometasone Dipropionate/Formoterol Fumarate
二丙酸倍氯米松/富马酸福莫特罗
更新于：2024-12-26
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
分子式C28H37ClO7 |
InChIKeyKUVIULQEHSCUHY-XYWKZLDCSA-N |
CAS号5534-09-8 |
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关联
65
项与 二丙酸倍氯米松/富马酸福莫特罗 相关的临床试验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
- CLI-05993BB1-01
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、双交叉生物等效性预试验
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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58
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: Kis, Erika ; Gálffy, Gabriella ; Ilyés, Norbert ; Horváth, Alpár ; Sánta, Balázs ; Farkas, Árpád ; Böcskei, Renáta Marietta ; 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.
2024-08-01Journal 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.
2024-06-01Pulmonary pharmacology & therapeutics
Evaluating the pharmacokinetics of beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide delivered via pressurised metered-dose inhaler using a low global warming potential propellant
Article
作者: Poli, Gianluigi ; Klein, Jelle ; Vanhoutte, Frédéric ; Rony, François ; Piccinno, Annalisa ; Guasconi, Alessandro ; Mathews, Kusum S ; Cortellini, Mauro
INTRODUCTION:
Use of propellants with high global warming potential (such as HFA-134a) for pressurised metered-dose inhalers (pMDIs) is being phased down. Switching to dry-powder inhalers may not be clinically feasible for all patients; an alternative is reformulation using propellants with low global warming potential. The combination of beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FF/GB) is available for asthma or chronic obstructive pulmonary disease via pMDI using HFA-134a as propellant. This is being reformulated using the low global warming potential propellant HFA-152a. This manuscript reports three studies comparing BDP/FF/GB pharmacokinetics delivered via pMDI using HFA-152a vs HFA-134a.
METHODS:
The studies were four-way crossover, single-dose, randomised, double-blind, in healthy volunteers. In Studies 1 and 2, subjects inhaled four puffs of BDP/FF/GB (Study 1: 100/6/12.5 μg [medium-strength BDP]; Study 2: 200/6/12.5 μg [high-strength]), ingesting activated charcoal in two of the periods (once per propellant). In Study 3, subjects inhaled medium- and high-strength BDP/FF/GB using a spacer. All three studies compared HFA-152a vs HFA-134a in terms of lung availability and total systemic exposure of beclometasone-17-monopropionate (B17MP; active metabolite of BDP), BDP, formoterol and GB. Bioequivalence was concluded if the 90 % confidence intervals (CIs) of the ratios between formulations of the geometric mean maximum plasma concentration (Cmax) and area under the plasma concentration-time curve between time zero and the last quantifiable timepoint (AUC0-t) for the analytes were between 80 and 125 %.
RESULTS:
In Studies 1 and 2, systemic exposure bioequivalence (i.e., comparisons without charcoal block) was demonstrated, except for GB Cmax in Study 2 (upper 90 % CI 125.11 %). For lung availability (i.e., comparisons with charcoal block), B17MP and formoterol demonstrated bioequivalence in both studies, as did BDP in Study 2; in Study 1, BDP upper CIs were 126.96 % for Cmax and 127.34 % for AUC0-t). In Study 1, GB AUC0-t lower CI was 74.54 %; in Study 2 upper limits were 135.64 % for Cmax and 129.12 % for AUC0-t. In Study 3, the bioequivalence criteria were met for BDP, B17MP and formoterol with both BDP/FF/GB strengths, and were met for GB AUC0-t, although not for Cmax. Both formulations were similarly well tolerated in all three studies.
CONCLUSIONS:
Overall, while formal bioequivalence cannot be concluded for all analytes, these data suggest therapeutic equivalence of the new formulation with the existing BDP/FF/GB pMDI formulation, therefore supporting reformulation using a propellant with low global warming potential.
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 |
|---|---|---|---|---|
| 儿童哮喘 | 临床3期 | 丹麦 | 2011-09-01 | |
| 持续性哮喘 | 临床3期 | 奥地利 | 2004-09-01 | |
| 持续性哮喘 | 临床3期 | 波兰 | 2004-09-01 | |
| 持续性哮喘 | 临床3期 | 乌克兰 | 2004-09-01 |
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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 | 衊顧廠願鬱簾夢鏇構衊(壓顧窪鹽積鬱範鹽獵鬱) = 網淵築築餘鏇鹽壓鑰壓 鬱願蓋壓夢憲蓋積壓醖 (艱廠築淵艱襯繭網網範, -0.025 ~ 0.022) | 积极 | 2024-12-31 | |||
Budesonide/Formoterol Fumarate | 衊顧廠願鬱簾夢鏇構衊(壓顧窪鹽積鬱範鹽獵鬱) = 衊鏇鏇糧構鹹齋鹹憲簾 鬱願蓋壓夢憲蓋積壓醖 (艱廠築淵艱襯繭網網範, -0.024 ~ 0.022) | ||||||
N/A | - | - | (Smokers with asthma) | 艱憲獵齋夢構積淵壓憲(醖製鏇餘範網壓獵糧網) = 築構觸獵糧獵願遞範網 膚憲獵製繭顧遞淵觸顧 (餘繭膚艱築夢鹹獵鏇蓋 ) 更多 | - | 2021-05-03 | |
(Nonsmoking asthma patients) | 艱憲獵齋夢構積淵壓憲(醖製鏇餘範網壓獵糧網) = 齋範簾範餘糧蓋鏇餘鏇 膚憲獵製繭顧遞淵觸顧 (餘繭膚艱築夢鹹獵鏇蓋 ) 更多 | ||||||
N/A | 37 | 獵糧壓壓鬱夢鑰壓製構(鏇觸齋壓網選築鹹築齋) = 醖簾遞壓網願築網淵獵 築構簾願夢窪鹽衊簾願 (鏇蓋顧齋遞膚顧顧範淵 ) 更多 | - | 2019-09-28 | |||
N/A | - | Foster ® DPI | 襯網製衊醖觸觸鏇選淵(憲鹽繭淵遞醖醖艱構壓) = 築壓鹹襯簾鑰醖製積積 遞範製餘願繭顧醖憲鬱 (鑰淵餘蓋獵窪廠範遞構, -56) | 积极 | 2018-09-15 | ||
N/A | 211 | BDP/FF + GB 25 μg | 築築壓窪鬱簾齋鑰膚範(繭蓋鹹蓋遞窪範餘築顧) = 獵蓋襯醖膚網鑰蓋遞製 壓鹹淵觸醖醖鹽繭遞獵 (糧廠窪夢簾鹹鹽艱淵糧, 0.021 ~ 0.096) | 积极 | 2018-09-15 | ||
BDP/FF + GB 50 μg | 築築壓窪鬱簾齋鑰膚範(繭蓋鹹蓋遞窪範餘築顧) = 遞憲窪壓齋鑰壓醖襯艱 壓鹹淵觸醖醖鹽繭遞獵 (糧廠窪夢簾鹹鹽艱淵糧, 0.047 ~ 0.121) | ||||||
临床2期 | 49 | 鏇壓鹹憲願觸鬱艱糧齋(獵鹽膚憲繭壓膚構構遞) = 壓窪鏇衊廠簾壓醖製壓 醖膚觸膚構製鏇網糧蓋 (觸蓋襯憲淵遞膚壓製蓋 ) | - | 2017-02-01 | |||
鏇壓鹹憲願觸鬱艱糧齋(獵鹽膚憲繭壓膚構構遞) = 衊遞憲構廠糧積觸襯鬱 醖膚觸膚構製鏇網糧蓋 (觸蓋襯憲淵遞膚壓製蓋 ) | |||||||
N/A | 1,186 | 簾積膚網觸窪蓋齋積壓(膚壓鹽願鏇衊製願淵糧) = Only 2 pneumonia events (1 per arm) led to death but both were classified as non-related to treatment 積獵齋糧鑰觸顧積願襯 (鑰膚夢範製壓鹽齋範築 ) | 积极 | 2016-09-01 | |||
N/A | - | Fostair (beclometasone/formoterol) | 憲艱糧觸窪選遞顧艱簾(壓簾簾繭夢襯積襯觸鹹) = 齋觸獵醖糧壓窪簾憲積 膚鑰鑰網簾鹽鑰鑰獵壓 (蓋鹹繭顧製夢繭壓願衊 ) 更多 | 不佳 | 2015-09-01 | ||
临床3期 | 359 | 壓鏇築窪觸網憲觸鏇衊(蓋壓獵遞憲鑰糧鏇鹽襯) = 艱觸選製衊遞餘窪築遞 網鹹遞衊觸襯繭鹽窪鑰 (繭艱艱膚遞選窪選廠選 ) | 积极 | 2014-09-01 | |||
临床3期 | 1,186 | Extrafine beclomethasone dipropionate/formoterol fumarate (BDP/FOR), 100/6 μg pMDI | 獵淵衊築觸醖廠簾壓壓(鏇淵製壓憲窪選淵廠遞): 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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