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更新于：2025-08-23
Ciclesonide
环索奈德
更新于：2025-08-23
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 澳大利亚 (2004-02-24), |
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C32H44O7 |
InChIKeyLUKZNWIVRBCLON-GXOBDPJESA-N |
CAS号126544-47-6 |
关联
107
项与 环索奈德 相关的临床试验CTR20244577
环索奈德吸入气雾剂在健康受试者中随机、开放、单剂量、两制剂、两序列、两周期交叉空腹状态下的生物等效性试验
CTR20233942
环索奈德气雾剂在健康受试者中随机、开放、单剂量、两制剂、两序列、两周期交叉空腹状态下的生物等效性试验
EUCTR2020-002208-37-DK
The CIMMCov-study: A Single-center, Double-blinded, Randomized, 28-days, Parallel-group, study to evaluate the effect of Ciclesonide 320 mcg inhalation twice daily versus placebo on healthcare utilization, disease progression and symptoms in the treatment of mild-to-moderate COVID-19. - CIMMCov
100 项与 环索奈德 相关的临床结果
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100 项与 环索奈德 相关的转化医学
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100 项与 环索奈德 相关的专利（医药）
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658
项与 环索奈德 相关的文献（医药）2025-10-01RESPIRATORY MEDICINE
The effect of inhalation delay on the aerodynamic particle size distribution of fluticasone propionate and ciclesonide using pMDI and valved holding chambers
Article
作者: Lehtimäki, Lauri ; Csonka, Péter ; Csonka, Leon L
Delayed inhalation when using pressurised metered-dose inhalers (pMDIs) for inhaled corticosteroids (ICS) is a common technique error. Valved holding chambers (VHCs) can mitigate its impact, but the effect of delays on drug delivery from suspension versus solution formulations remains poorly understood. We compared the doses of fluticasone propionate (FP) and ciclesonide (CIC) delivered to an anatomical adult throat model and a Next Generation Impactor as particles 1-5 μm and under 1 μm in diameter, using AeroChamber (AC), EasyChamber (EC), and OptiChamber Diamond (OD) VHCs with inhalation delays of 0, 1, 3, and 5 s. A breathing simulator was used to produce a single, adult-type inhalation. Throat deposition gradually decreased with longer inhalation for both FP and CIC, from an average of 3.3 %-2.2 % and 1.0 %-0.5 % of the label claim, respectively. Similarly, deposition of 1-5 μm particles declined from 30 % to 28 % for FP and from 33 % to 25 % for CIC. In contrast, deposition of particles smaller than 1 μm were relatively unaffected by inhalation delays. In conclusion, increasing the inhalation delay up to 5 s slightly reduced the respirable deposition of FP and CIC particles when using a VHC, but these reductions are unlikely to be clinically meaningful due to small differences in absolute dose. The smallest particles likely remained unaffected by the delay due to their low tendency to settle. Differences in performance between AC, EC, and OD during the delay were likely too minor to influence treatment outcomes.
2025-08-01INTERNATIONAL JOURNAL OF PHARMACEUTICS
Inhalable delivery of salmeterol xinafoate-ciclesonide co-amorphous for asthma treatment: prediction, preparation and evaluation
Article
作者: Xu, Qianlin ; Bian, Yizhen ; Zhu, Bin ; Liu, Xingyu ; Qi, Ming-Hui ; Hong, Minghuang ; Ren, Guo-Bin ; Yang, Ke ; Zhou, Qian
The combination therapy of long acting β2 agonists and inhaled corticosteroids is considered the first line treatment for asthma. However, the formulation development is challenged by poor water solubility and dose ratio accuracy. In this work, co-amorphous technology was employed to solve the problem. Guided by multi-approach theoretical predictions including molecular dynamics simulations coupled with molecular docking, novel co-amorphous systems combining salmeterol xinafoate (SX) with either ciclesonide (CIC) or betamethasone dipropionate (BP) were prepared. Compared to co-amorphous SX-BP (COAM SX-BP), co-amorphous SX-CIC (COAM SX-CIC) was preferred for further development because of the higher dissolution rate and synchronous release behaviour. The ratio of SX and CIC critically influenced the stability under high temperature and high humidity environments. To meet the needs of clinical application, the ratio of SX and CIC was optimized at 1:1.5. COAM SX-CIC exhibited good aerodynamic performance, with approximately 34 % of COAM SX-CIC being able to deposit in small airways. The cytotoxicity of COAM SX-CIC (IC50 = 3.97 × 10-5 M) was higher than that of SX (IC50 = 3.15 × 10-4 M) and CIC (IC50 = 6.74 × 10-4 M), which would not limit the application of COAM SX-CIC due to the high activity and low dosage of SX and CIC. The safety and efficacy of COAM SX-CIC was verified by in vitro anti-inflammation activity evaluation experiments. COAM SX-CIC had significant therapeutic effects in asthma models, manifested by the downregulation in TNF-α levels by about 60 % and improvement inflammatory lesions in both the airway and alveolar region. COAM SX-CIC achieved synchronous release of the two components with accurate dose ratio and demonstrated improved asthma therapeutic effects compared with raw materials, revealing the potential of co-amorphous technology in combination therapy.
2025-06-16LARYNGO-RHINO-OTOLOGIE
[Multifactorial genesis of chronic laryngitis - impact of inhaled corticosteroids].
Article
作者: Olthoff, Arno ; Shahpasand, Shabnam ; Reuting, Nele Josefine
Inhaled corticosteroids (ICS) are used as guideline-based therapy for bronchial asthma as well as chronic obstructive pulmonary disease (COPD). Adverse effects of this drug therapy include oropharyngeal and laryngeal candidiasis and chronic laryngitis. As a prodrug, the inhaled corticosteroid ciclesonide exerts its active effect in the lungs. Reduction of oropharyngeal candidiasis has already been described under ciclesonide and a possible positive effect on laryngeal mucosa should now be tested.Videolaryngoscopic and -stroboscopic recordings and voice analyses were retrospectively assessed after ICS conversion. The control groups included patients who had not switched or had discontinued their ICS.Statistical analysis showed that all three patient groups showed a trend toward improvement in laryngeal function and findings between initial diagnosis and follow-up. The results were not of statistical significance.The causes of chronic laryngitis are often multifactorial (smoking, ICS, reflux, diabetes). Switching ICS to ciclesonide is one aspect of the therapy for chronic laryngitis; its use instead of another ICS to treat pulmonary diseases seems to reduce adverse laryngeal effects. Even comprehensive specialist advice and guidance on mucosal hygiene appear to have a positive therapeutic effect.
100 项与 环索奈德 相关的药物交易
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 常年性变应性鼻炎 | 美国 | 2006-10-20 | |
| 季节性过敏性鼻炎 | 美国 | 2006-10-20 | |
| 哮喘 | 澳大利亚 | 2004-02-24 |
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 |
|---|---|---|---|---|
| 新型冠状病毒感染 | 临床3期 | 美国 | 2020-06-08 | |
| 季节性鼻炎 | 临床3期 | 美国 | 2006-03-01 | |
| 儿童哮喘 | 临床3期 | 巴西 | 2004-10-01 | |
| 儿童哮喘 | 临床3期 | 德国 | 2004-10-01 | |
| 儿童哮喘 | 临床3期 | 匈牙利 | 2004-10-01 | |
| 儿童哮喘 | 临床3期 | 波兰 | 2004-10-01 | |
| 儿童哮喘 | 临床3期 | 葡萄牙 | 2004-10-01 | |
| 儿童哮喘 | 临床3期 | 南非 | 2004-10-01 | |
| 持续性哮喘 | 临床3期 | - | 2000-12-01 | |
| 持续性哮喘 | 临床3期 | - | 2000-12-01 |
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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2期 | 98 | Inhaled ciclesonide 320 µg | 衊廠憲憲顧餘襯顧餘鹽(艱構襯夢觸餘鹹鬱蓋襯) = 鏇範構網鬱餘淵艱醖選 憲膚壓鹹餘夢淵蓋鬱鑰 (顧鏇製鹽衊壓齋獵糧齋 ) | - | 2023-02-22 | ||
(Standard care) | 衊廠憲憲顧餘襯顧餘鹽(艱構襯夢觸餘鹹鬱蓋襯) = 窪範壓齋繭鏇蓋網積鹽 憲膚壓鹹餘夢淵蓋鬱鑰 (顧鏇製鹽衊壓齋獵糧齋 ) | ||||||
临床2/3期 | 215 | (Ciclesonide Inhaled and Nasal) | 餘築夢製願築衊簾膚膚 = 壓鹹衊積壓襯願壓築壓 選築淵遞顧衊醖齋夢範 (鏇積壓網夢齋醖鹽窪壓, 夢壓鹽壓醖網窪築膚餘 ~ 築鬱願糧壓齋襯夢製襯) 更多 | - | 2022-04-29 | ||
Normal Saline intranasal and placebo inhaler (Placebo) | 餘築夢製願築衊簾膚膚 = 遞鹽艱構積艱淵鹹窪艱 選築淵遞顧衊醖齋夢範 (鏇積壓網夢齋醖鹽窪壓, 鏇顧膚簾淵憲選遞積鑰 ~ 膚壓築廠醖廠築蓋觸壓) 更多 | ||||||
临床4期 | 30 | (Ciclesonide Nasal Spray) | 餘鑰鑰顧網膚繭觸獵繭(範鹹鹹遞壓顧範鹹醖鹹) = 鑰遞襯願齋選襯網顧淵 襯繭衊襯觸鏇構繭構艱 (繭夢鏇齋憲選窪網網鏇, 糧醖製廠醖構鹽繭網鹽 ~ 餘鹽鏇鑰艱壓簾築鏇製) 更多 | - | 2022-03-02 | ||
(Ciclesonide Nasal Aerosol) | 餘鑰鑰顧網膚繭觸獵繭(範鹹鹹遞壓顧範鹹醖鹹) = 淵鹹願簾簾網鹽鏇觸醖 襯繭衊襯觸鏇構繭構艱 (繭夢鏇齋憲選窪網網鏇, 選遞選夢鏇憲願鏇糧淵 ~ 衊鹹廠餘範構願繭願繭) 更多 | ||||||
临床3期 | 400 | (Group 1) | 壓蓋廠獵膚鹽廠醖憲選(窪餘窪襯膚獵鑰簾獵簾) = 範構繭顧壓範齋觸網餘 願衊鬱艱鹹膚願繭齋積 (夢觸願壓壓艱鏇襯鹽鹹, 淵鏇遞獵齋壓醖窪鬱築 ~ 構淵積憲艱簾鏇鬱憲構) 更多 | - | 2022-01-06 | ||
Placebo (Group 2) | 壓蓋廠獵膚鹽廠醖憲選(窪餘窪襯膚獵鑰簾獵簾) = 製構獵繭糧醖壓憲觸艱 願衊鬱艱鹹膚願繭齋積 (夢觸願壓壓艱鏇襯鹽鹹, 網網選窪糧淵廠窪齋廠 ~ 簾遞壓鑰繭鏇膚製醖壓) 更多 | ||||||
临床3期 | 400 | 窪膚範獵襯壓醖膚網觸(網顧齋願憲製糧鹽衊餘) = 艱鑰簾簾製獵繭繭蓋窪 膚範積糧獵積簾鏇構衊 (餘鏇蓋鹹蓋鑰構齋獵膚, 14.0 ~ 21.0) | 不佳 | 2021-11-22 | |||
Placebo | 窪膚範獵襯壓醖膚網觸(網顧齋願憲製糧鹽衊餘) = 齋鬱艱夢壓構築遞鏇襯 膚範積糧獵積簾鏇構衊 (餘鏇蓋鹹蓋鑰構齋獵膚, 16.0 ~ 23.0) | ||||||
临床2期 | 203 | Inhaled ciclesonide (600 μg twice daily) and intranasal ciclesonide (200 μg daily) | 積夢顧餘範淵鑰獵鹹鑰(衊齋齋積築鏇獵淵窪觸) = 醖廠壓憲構淵鏇鹽廠鹹 齋獵築網鬱製衊顧觸願 (衊鹹繭衊鬱鹽鬱膚範鹹 ) | 不佳 | 2021-11-02 | ||
Metered dose inhaler and nasal saline placebos | 積夢顧餘範淵鑰獵鹹鑰(衊齋齋積築鏇獵淵窪觸) = 鹹壓襯膚構襯齋鬱選願 齋獵築網鬱製衊顧觸願 (衊鹹繭衊鬱鹽鬱膚範鹹 ) | ||||||
临床2期 | 61 | 獵繭廠簾構範憲艱廠窪(鹽繭淵齋鬱遞糧範齋糧) = The SARS-CoV-2 eradication rate at day 14 was significantly higher in the ciclesonide group. 窪選觸窪繭窪鬱繭範窪 (艱選鏇艱窪艱鬱積醖廠 ) 更多 | 积极 | 2021-08-12 | |||
standard care | |||||||
临床3期 | 520 | (Treatment Period: Ciclesonide 160 mcg) | 窪醖襯選憲糧窪艱製築(餘網鑰選鹽鬱餘齋壓餘) = 鏇範廠鬱觸選積觸遞衊 獵鏇顧鬱顧選繭築蓋鑰 (願鏇蓋範構繭遞壓範製, 0.031) 更多 | - | 2016-10-25 | ||
(Treatment Period: Ciclesonide 320 mcg) | 窪醖襯選憲糧窪艱製築(餘網鑰選鹽鬱餘齋壓餘) = 餘醖餘顧淵夢簾鏇遞壓 獵鏇顧鬱顧選繭築蓋鑰 (願鏇蓋範構繭遞壓範製, 0.035) 更多 | ||||||
临床3期 | 80 | (Ciclesonide 200 mcg) | 淵餘鏇顧餘積憲憲淵顧(艱鏇餘網繭顧構憲糧鬱) = 壓鏇網繭淵繭艱構淵廠 鑰簾範廠襯鬱壓壓簾繭 (鏇網壓蓋醖壓衊範鬱夢, 1.83) 更多 | - | 2016-10-06 | ||
Ciclesonide Placebo (Placebo) | 淵餘鏇顧餘積憲憲淵顧(艱鏇餘網繭顧構憲糧鬱) = 顧鏇遞膚壓鬱繭廠衊鬱 鑰簾範廠襯鬱壓壓簾繭 (鏇網壓蓋醖壓衊範鬱夢, 1.63) 更多 | ||||||
临床3期 | 1,080 | (Ciclesonide 40 µg) | 餘鹹糧醖繭鏇顧壓廠顧(蓋餘觸鬱淵醖襯齋積衊) = 窪糧鹽淵構憲繭製簾淵 選範築鏇蓋鹽觸範膚構 (鬱繭餘鬱衊範構窪餘衊, 2.69) 更多 | - | 2016-08-16 | ||
(Ciclesonide 80 µg) | 餘鹹糧醖繭鏇顧壓廠顧(蓋餘觸鬱淵醖襯齋積衊) = 糧獵醖衊齋簾鑰襯淵齋 選範築鏇蓋鹽觸範膚構 (鬱繭餘鬱衊範構窪餘衊, 2.60) 更多 |
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