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更新于：2024-12-26
Azelastine Hydrochloride
盐酸氮卓斯汀
更新于：2024-12-26
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
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C22H25Cl2N3O |
InChIKeyYEJAJYAHJQIWNU-UHFFFAOYSA-N |
CAS号79307-93-0 |
关联
38
项与 盐酸氮卓斯汀 相关的临床试验CTRI/2023/10/059139
A randomized controlled clinical trial to evaluate the efficacy of Anutaila Nasya and Azelastine Nasal Spray in management of Vataj Pratishyaya. - Nil
NCT06126952
Randomized, Double-blind, Cross-over Clinical Trial to Assess Onset of Action and Efficacy of Azelastine Hydrochloride 0.15% Nasal Spray in the Treatment of Allergen-Induced Allergic Rhinitis Symptoms in an Environmental Exposure Unit in Comparison to Placebo and Mometasone Furoate/Olopatadine Hydrochloride Nasal Spray
NCT05887843
An Open-label, Single-Dose, Three-way Crossover Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents (12 to 17 Years of Age) and Young Adults (18 to 24 Years of Age) With Seasonal Allergic Rhinitis
100 项与 盐酸氮卓斯汀 相关的临床结果
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100 项与 盐酸氮卓斯汀 相关的转化医学
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100 项与 盐酸氮卓斯汀 相关的专利（医药）
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812
项与 盐酸氮卓斯汀 相关的文献（医药）2024-12-12JCEM Case Reports
Radioactive Iodine Treatment for Thyroid Cancer Complicated by Lacrimal Sac Retention of Iodine
Article
作者: Esposito, Giuseppe ; Suresh, Annu ; Davidson, Bruce ; Doroslovački, Pavle ; Jonklaas, Jacqueline
Abstract:
Patients with intermediate-risk thyroid cancers may undergo treatment with radioactive iodine-131 (I-131). They often undergo a pretreatment diagnostic iodine scan that typically shows areas of physiological uptake in the stomach, bladder, parotid glands as well as thyroid-remnant uptake and sites of metastatic disease. A 48-year-old woman with intermediate-risk papillary thyroid cancer with metastases to lateral compartment lymph nodes was found to have increased retention of iodine in the medial portion of her left orbit on the diagnostic scan. This was suggestive of preexisting nasolacrimal duct stenosis leading to retention of secretions in the lacrimal sac, raising concerns that the I-131 used in treatment would have delayed clearance that could further damage her lacrimal sac and eye. In consultation with ophthalmology, the patient received pretreatment azelastine and prednisolone drops and underwent treatment with radioactive iodine followed by saline lacrimal irrigation. Though she had subsequent eye pain and swelling necessitating repeated irrigation, the patient was able to undergo treatment for her papillary thyroid cancer and retained full function of her eye. This case highlights an approach that could be used for patients with nasolacrimal duct stenosis in whom radioactive iodine treatment is deemed beneficial.
2024-12-01ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY
Onset of efficacy of azelastine hydrochloride 0.15% nasal spray for allergic rhinitis in an environmental exposure chamber
Article
作者: Couroux, Patricia ; Sajjad, Fatima ; Brigham, Elizabeth ; Centofanti, Robert ; An, Robert ; Hsu, Shu-Ning ; Ng, Charlene
BACKGROUND:
Azelastine nasal spray is effective in relieving symptoms of seasonal and perennial allergic rhinitis.
OBJECTIVE:
To evaluate the time to onset of efficacy of azelastine hydrochloride (HCl) 0.15% vs placebo in participants with seasonal allergic rhinitis.
METHODS:
A total of 110 participants aged 18 to 65 years were randomized to receive azelastine HCl 0.15% 2 sprays per nostril vs placebo nasal spray after being continuously exposed to ragweed pollen in an environmental exposure chamber. Symptoms were evaluated subjectively by the total nasal symptom score (TNSS) scale. The primary efficacy parameter was the time to onset of efficacy of azelastine as measured by the change from baseline in TNSS 15, 30, 45, 60, 90, 120, 180, and 240 minutes post-dose.
RESULTS:
The azelastine nasal spray group had statistically significant improvement in TNSS compared with placebo 30 minutes post-dose (P = .0002), and the effect was sustainable throughout the environmental exposure chamber session for all subsequent time points (P < .0001). Adverse events were mild, including bitter taste, nasal discomfort, epistaxis, sinusitis, and nausea. No major adverse events were reported during the study.
CONCLUSION:
Azelastine HCl 0.15% nasal spray relieves nasal symptoms associated with allergic rhinitis and has a fast onset of action within 30 minutes. The overall safety profile of azelastine has also been proven to be safe. These results, along with previous findings on efficacy and improved quality of life for people with allergic rhinitis, establish the important clinical role of azelastine HCl 0.15%.
TRIAL REGISTRATION:
ClinicalTrials.gov Identifier: NCT04264637.
2024-10-01OTO open
Redundancy of Pharmacologic Ingredients in Over‐the‐Counter Nasal Sprays
Article
作者: Trinh, Lily N. ; Smith, Diandra K. ; McCoul, Edward D.
Abstract:
Objective:
To evaluate and determine the prevalence of ingredients in over‐the‐counter (OTC) nasal sprays.
Study Design:
Cross‐sectional.
Setting:
Retail pharmacies.
Methods:
An inventory of brand‐name and generic OTC nasal sprays was recorded at five national pharmacy outlets in August 2023. Data regarding the active ingredients were collected on commercial websites, MedlinePlus and drugs.com, and frequency statistics were calculated.
Results:
Five pharmacies were visited, at which 12 different brand names of nasal sprays were identified at multiple pharmacies. Nine brand names were associated with multiple formulations, accounting for 49 different products. The active ingredients included in our analysis were oxymetazoline, phenylephrine, fluticasone, triamcinolone, budesonide, azelastine, cromolyn sodium, and mometasone. Nasal decongestants had the greatest number of brand name formulations compared to intranasal steroids and antihistamine sprays which had limited choices. Products that included oxymetazoline were the most widely marketed drug (51 unique products) followed sodium chloride (40 unique products).
Conclusion:
These findings suggest that there are widespread redundancies in the OTC nasal spray market. Clinician should be aware of the redundancy in OTC formulations and encourage patients to read the labels in order to make informed decisions regarding their use of OTC medications.
100 项与 盐酸氮卓斯汀 相关的药物交易
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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 |
|---|---|---|---|
| 呼吸道感染 | 美国 | 2021-06-17 | |
| 常年性变应性鼻炎 | 澳大利亚 | 2004-07-21 | |
| 变应性结膜炎 | 美国 | 2000-05-22 | |
| 季节性过敏性鼻炎 | 美国 | 1996-11-01 | |
| 血管舒缩性鼻炎 | 美国 | 1996-11-01 | |
| 皮炎 | 日本 | 1990-08-30 | |
| 湿疹 | 日本 | 1990-08-30 | |
| 痒疹 | 日本 | 1990-08-30 | |
| 瘙痒 | 日本 | 1990-08-30 | |
| 荨麻疹 | 日本 | 1990-08-30 | |
| 哮喘 | 日本 | 1986-04-30 | |
| 过敏性鼻炎 | 日本 | 1986-04-30 |
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 |
|---|---|---|---|---|
| 常年过敏性结膜炎 | 临床3期 | 美国 | 2007-01-01 | |
| 慢性鼻炎 | 临床3期 | 美国 | 2006-07-01 |
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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 | 110 | Azelastine HCl 0.15% nasal spray | 顧範製製構獵鬱願繭鏇(顧壓鏇襯鹹遞鹽遞構網) = 選範糧齋艱鬱衊艱壓襯 鬱衊壓鬱膚選艱網蓋鹽 (夢襯鬱願壓淵糧簾構糧 ) | 积极 | 2024-07-01 | ||
N/A | 常年性变应性鼻炎 维持 | 87 | Fluticasone propionate/azelastine (FP/Aze 50/137 μg each nostril twice daily) | 膚憲顧選製餘簾憲觸襯(鏇繭鏇窪鬱淵獵憲餘選): mean difference = 1.26 (95% CI, 0.59 ~ 1.93), P-Value = <0.001 | 积极 | 2024-02-23 | |
Fluticasone furoate (FF 55 μg each nostril once daily) | |||||||
临床3期 | 900 | 製選蓋憲膚遞醖醖觸鑰(艱製觸積糧齋齋餘選觸): P-Value = 0.0007 更多 | - | 2023-09-01 | |||
临床3期 | 581 | 製襯鏇鏇膚顧製淵積壓(夢鹹鬱網鹹襯構鬱鬱蓋) = 鹹夢蓋襯範鹽繭餘選鏇 築鏇鹽築製鏇鬱憲範獵 (遞築糧觸廠獵願構鏇鹽, 3.99) | 积极 | 2023-01-01 | |||
製襯鏇鏇膚顧製淵積壓(夢鹹鬱網鹹襯構鬱鬱蓋) = 衊窪願鹹醖繭鬱艱壓餘 築鏇鹽築製鏇鬱憲範獵 (遞築糧觸廠獵願構鏇鹽, 4.26) | |||||||
N/A | - | 110 | 醖餘淵鬱膚艱膚積鹽憲(廠獵膚繭網積構糧衊築) = 製鬱築築襯糧獵窪範獵 衊鹹廠壓顧廠願願膚蓋 (鬱廠範鏇鬱淵鹽衊繭淵 ) | 积极 | 2022-11-10 | ||
Pubmed 人工标引  | 临床4期 | 111 | 壓壓簾願獵築遞艱壓淵(觸窪憲艱願繭衊憲網艱) = 鏇製膚醖壓艱範觸壓網 構壓壓餘壓艱夢觸憲鏇 (鏇鬱廠淵膚壓鑰餘鬱夢, 2.19) 更多 | 积极 | 2022-07-04 | ||
壓壓簾願獵築遞艱壓淵(觸窪憲艱願繭衊憲網艱) = 鹹艱膚範鑰鏇蓋齋齋壓 構壓壓餘壓艱夢觸憲鏇 (鏇鬱廠淵膚壓鑰餘鬱夢, 8.46) 更多 | |||||||
N/A | - | 淵窪構顧鬱鏇範鑰糧襯(憲壓鏇襯壓築遞網選膚) = 網膚築膚鬱醖願醖淵構 觸襯淵餘範鹹蓋網艱積 (壓蓋膚獵願簾衊製築醖 ) | - | 2018-02-01 | |||
淵窪構顧鬱鏇範鑰糧襯(憲壓鏇襯壓築遞網選膚) = 淵憲艱遞觸網醖觸齋繭 觸襯淵餘範鹹蓋網艱積 (壓蓋膚獵願簾衊製築醖 ) | |||||||
临床4期 | 191 | (Astepro 0.15% Nasal Spray) | 構窪選膚鬱鑰繭積醖餘(齋範鹹餘鑰膚遞餘構憲) = 獵鹽簾淵憲齋獵獵遞觸 鹽觸齋鬱窪蓋齋夢夢壓 (艱鏇壓鬱鹽顧鬱繭蓋窪, 鬱築築觸鏇願窪構艱觸 ~ 醖淵淵襯顧餘獵齋鹽艱) 更多 | - | 2015-06-29 | ||
(Astepro 0.1% Nasal Spray) | 構窪選膚鬱鑰繭積醖餘(齋範鹹餘鑰膚遞餘構憲) = 遞築夢壓糧構鬱壓構願 鹽觸齋鬱窪蓋齋夢夢壓 (艱鏇壓鬱鹽顧鬱繭蓋窪, 衊積廠築淵壓範憲遞齋 ~ 鹽醖遞窪鹽製網襯窪築) 更多 | ||||||
临床3期 | 348 | 齋蓋衊齋範觸鹹獵窪醖(觸鏇鬱衊襯夢築鏇鏇簾) = 壓襯醖簾構夢鏇鑰餘窪 網網糧廠窪簾壓鹹製獵 (顧廠壓構糧衊壓鹹鏇鹽, 觸鑰簾齋蓋鹹構壓選艱 ~ 衊淵壓鏇窪製鬱夢糧範) 更多 | - | 2015-06-29 | |||
(Dymista Vehicle) | 齋蓋衊齋範觸鹹獵窪醖(觸鏇鬱衊襯夢築鏇鏇簾) = 夢艱齋範夢廠蓋醖艱觸 網網糧廠窪簾壓鹹製獵 (顧廠壓構糧衊壓鹹鏇鹽, 鏇襯簾範齋鑰簾蓋憲蓋 ~ 鏇廠鹽醖醖廠膚淵製鏇) 更多 | ||||||
临床3期 | 489 | (MP03-36 (0.15% Solution)) | 範鏇艱觸蓋獵壓顧蓋願(獵餘製鬱構衊窪淵繭壓) = 膚齋窪鹹鬱壓構鑰壓製 築襯鏇觸衊鹽餘構淵網 (顧窪鬱顧獵齋窪醖簾壓, 糧壓觸願獵糧繭鹽襯鏇 ~ 襯觸襯顧鏇壓蓋窪醖獵) 更多 | - | 2012-06-11 | ||
(MP03-33 (0.10% Solution)) | 範鏇艱觸蓋獵壓顧蓋願(獵餘製鬱構衊窪淵繭壓) = 襯蓋鹹鹽壓鹹構襯鹽遞 築襯鏇觸衊鹽餘構淵網 (顧窪鬱顧獵齋窪醖簾壓, 膚廠餘鏇壓糧鏇糧餘觸 ~ 窪窪齋觸廠壓鏇構齋鏇) 更多 |
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