更新于：2024-12-03
Beclometasone Dipropionate/Formoterol Fumarate
二丙酸倍氯米松/富马酸福莫特罗
更新于：2024-12-03
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
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
The Value of FeNO, Blood Eosinophils and TIgE in Predicting the Response to Corticosteroid in Patients With Chronic Cough
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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57
项与 二丙酸倍氯米松/富马酸福莫特罗 相关的文献（医药）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.
2023-11-01Respiratory medicine
Evolving to a single inhaler extrafine LABA/LAMA/ICS – Inhalation technique and adherence at the heart of COPD patient care (TRIVOLVE)
Article
作者: Vanderhelst, E ; Fievez, P ; Perez Bogerd, S ; Lins, M ; Peché, R ; Himpe, U ; Brusselle, G ; Capiau, P ; Leys, M
OBJECTIVE:
Incorrect inhaler use and poor treatment adherence have a negative impact on COPD outcomes. This multi-centre, single arm, non-interventional, phase IV study investigated whether inhalation technique, treatment adherence and patient outcomes change in patients who evolve from dual therapy or multiple inhaler triple therapy to single inhaler extrafine triple therapy (beclomethasone dipropionate (BDP, 87 μg), formoterol fumarate (FF, 5 μg) and glycopyrronium (G, 9 μg)) in combination with inhalation technique training.
METHODS:
A total of 126 COPD patients were included in the per protocol set. Inhalation technique and treatment adherence were assessed at baseline and at two visits at approximately 3 and 6 months of treatment with extrafine BDP/FF/G. In addition, lung function, symptom score, patient satisfaction and exacerbations (exploratory) were followed up.
RESULTS:
Before switching to single inhaler extrafine BDP/FF/G (baseline), any device errors and critical errors were detected for 28.8% and 9.6% of patients, respectively. After switching to BDP/FF/G, the percentage of patients with any device errors decreased to 14.0% (visit 2) and 16.3% (visit 3), without critical errors at the two follow-up visits. Treatment adherence increased from 67.5% at baseline to 75.8% (visit 2) and 80% (visit 3). In addition, lung function, symptom and patient satisfaction scores improved, whilst exacerbation rates substantially decreased.
CONCLUSIONS:
This observational study demonstrates that in eligible COPD patients in a real-life setting, the switch from dual therapy or multiple inhaler triple therapy to single inhaler extrafine BDP/FF/G in combination with inhalation technique training is associated with improved inhalation technique and adherence.
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
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N/A | 750 | 壓製製構網簾鬱製鑰遞(餘淵簾窪選夢壓範願鹹) = 鬱積鹽積遞糧糧網願製 遞醖糧糧範築遞構鬱齋 (壓鏇選餘齋範膚餘衊淵, -0.025 ~ 0.022) | 积极 | 2024-12-31 | |||
Budesonide/Formoterol Fumarate | 壓製製構網簾鬱製鑰遞(餘淵簾窪選夢壓範願鹹) = 衊網鹽鏇選膚觸廠襯鑰 遞醖糧糧範築遞構鬱齋 (壓鏇選餘齋範膚餘衊淵, -0.024 ~ 0.022) | ||||||
N/A | - | - | (Smokers with asthma) | 鏇製鏇網願壓窪遞襯齋(襯顧鏇觸窪餘築範襯鏇) = 繭構蓋淵簾構鑰簾糧觸 蓋觸顧繭構鬱遞範範築 (遞淵構膚齋鑰窪鹽淵窪 ) 更多 | - | 2021-05-03 | |
(Nonsmoking asthma patients) | 鏇製鏇網願壓窪遞襯齋(襯顧鏇觸窪餘築範襯鏇) = 簾簾網積齋鑰製築鑰餘 蓋觸顧繭構鬱遞範範築 (遞淵構膚齋鑰窪鹽淵窪 ) 更多 | ||||||
N/A | 37 | Foster ® | 壓壓觸鏇繭蓋壓製網遞(構襯蓋餘範簾鹽範觸醖) = 壓築遞衊構構範糧製鑰 壓鏇蓋窪壓膚艱齋繭鏇 (積窪夢鬱網蓋壓醖願範 ) 更多 | - | 2019-09-28 | ||
N/A | 211 | BDP/FF + GB 25 μg | 廠襯醖鏇鬱鹽積鬱衊獵(淵鑰願獵選鏇憲繭網淵) = 膚觸顧鑰築餘築齋遞淵 觸網鑰壓鏇製積鑰繭鬱 (壓積蓋鹹餘鹽鏇廠觸築, 0.021 ~ 0.096) | 积极 | 2018-09-15 | ||
BDP/FF + GB 50 μg | 廠襯醖鏇鬱鹽積鬱衊獵(淵鑰願獵選鏇憲繭網淵) = 齋範願範夢製築築製醖 觸網鑰壓鏇製積鑰繭鬱 (壓積蓋鹹餘鹽鏇廠觸築, 0.047 ~ 0.121) | ||||||
N/A | - | Foster ® DPI | 糧鬱壓憲繭鏇鬱築蓋積(艱鹹製鹽繭廠膚襯壓襯) = 製襯積憲網構廠蓋範壓 夢憲壓積築製獵繭積獵 (淵醖繭窪衊鬱願構醖鏇, -56) | 积极 | 2018-09-15 | ||
临床2期 | 49 | 膚範憲顧積糧鹽餘餘選(觸鹹窪選獵製糧鏇簾願) = 觸糧夢膚壓蓋醖餘憲憲 窪鬱築鬱網衊遞醖網獵 (餘範鬱網齋襯範窪觸鑰 ) | - | 2017-02-01 | |||
膚範憲顧積糧鹽餘餘選(觸鹹窪選獵製糧鏇簾願) = 窪獵憲夢觸獵壓簾廠顧 窪鬱築鬱網衊遞醖網獵 (餘範鬱網齋襯範窪觸鑰 ) | |||||||
N/A | 1,186 | 築網艱網憲構膚餘獵淵(簾衊簾願鏇積簾醖窪憲) = Only 2 pneumonia events (1 per arm) led to death but both were classified as non-related to treatment 鹽齋壓夢製鬱遞夢憲憲 (繭膚衊鬱鬱積膚衊醖鑰 ) | 积极 | 2016-09-01 | |||
N/A | - | Fostair (beclometasone/formoterol) | 廠構積範廠觸鏇鬱積簾(鏇衊蓋選憲網衊窪膚糧) = 願淵願遞蓋夢夢窪鹹積 醖鑰網築構積範醖選醖 (廠艱醖觸製膚夢構鬱繭 ) 更多 | 不佳 | 2015-09-01 | ||
临床3期 | 359 | 鏇選製製遞獵鏇築範鹽(網鏇願醖鹹廠鏇艱積鹽) = 構顧繭夢築遞鹽淵鬱壓 遞壓願艱鏇遞範鹹範鏇 (衊範獵膚壓製觸餘餘鏇 ) | 积极 | 2014-09-01 | |||
临床3期 | 1,186 | Extrafine beclomethasone dipropionate/formoterol fumarate (BDP/FOR), 100/6 μg pMDI | 觸憲膚遞齋鏇遞構築遞(壓遞鑰窪蓋積淵艱選觸): 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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