更新于：2024-12-12
Azelastine Hydrochloride
盐酸氮卓斯汀
更新于：2024-12-12
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
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A randomized controlled clinical trial to evaluate the efficacy of Anutaila Nasya and Azelastine Nasal Spray in management of Vataj Pratishyaya. - Nil
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
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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810
项与 盐酸氮卓斯汀 相关的文献（医药）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 ; Centofanti, Robert ; Sajjad, Fatima ; Brigham, Elizabeth ; 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.
2024-08-01JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
Intranasal antihistamines and corticosteroids in allergic rhinitis: A systematic review and meta-analysis
Review
作者: Cardoso-Fernandes, António ; Zuberbier, Torsten ; Vieira, Rafael José ; Lourenço-Silva, Nuno ; Klimek, Ludger ; Sousa-Pinto, Bernardo ; Gil-Mata, Sara ; Brozek, Jan ; Schünemann, Holger J ; Ferreira, André ; Ferreira-da-Silva, Renato ; Bedbrook, Anna ; Fonseca, João A ; Bousquet, Jean
BACKGROUND:
There is insufficient systematized evidence on the effectiveness of individual intranasal medications in allergic rhinitis (AR).
OBJECTIVES:
We sought to perform a systematic review to compare the efficacy of individual intranasal corticosteroids and antihistamines against placebo in improving the nasal and ocular symptoms and the rhinoconjunctivitis-related quality of life of patients with perennial or seasonal AR.
METHODS:
The investigators searched 4 electronic bibliographic databases and 3 clinical trials databases for randomized controlled trials (1) assessing adult patients with seasonal or perennial AR and (2) comparing the use of intranasal corticosteroids or antihistamines versus placebo. Assessed outcomes included the Total Nasal Symptom Score, the Total Ocular Symptom Score, and the Rhinoconjunctivitis Quality-of-Life Questionnaire. The investigators performed random-effects meta-analyses of mean differences for each medication and outcome. The investigators assessed evidence certainty using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach.
RESULTS:
This review included 151 primary studies, most of which assessed patients with seasonal AR and displayed unclear or high risk of bias. Both in perennial and seasonal AR, most assessed treatments were more effective than placebo. In seasonal AR, azelastine-fluticasone, fluticasone furoate, and fluticasone propionate were the medications with the highest probability of resulting in moderate or large improvements in the Total Nasal Symptom Score and Rhinoconjunctivitis Quality-of-Life Questionnaire. Azelastine-fluticasone displayed the highest probability of resulting in moderate or large improvements of Total Ocular Symptom Score. Overall, evidence certainty was considered "high" in 6 of 46 analyses, "moderate" in 23 of 46 analyses, and "low"/"very low" in 17 of 46 analyses.
CONCLUSIONS:
Most intranasal medications are effective in improving rhinitis symptoms and quality of life. However, there are relevant differences in the associated evidence certainty.
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 | 選艱網觸齋窪積醖廠夢(遞糧繭選顧鑰網鏇範鏇) = 獵鹹觸襯製鹽艱襯觸網 繭壓夢簾築遞獵積選願 (鹽夢糧顧積夢鑰網繭廠 ) | 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) | 網壓醖獵壓廠遞壓鏇遞(獵網網簾構蓋遞鑰築鏇): 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 | 醖齋鹹繭襯顧獵壓顧構(餘構鑰鏇鹹構醖夢遞獵): P-Value = 0.0007 更多 | - | 2023-09-01 | |||
临床3期 | 581 | 構獵憲衊鏇窪夢窪糧鬱(膚願膚壓醖蓋餘願遞網) = 範餘憲襯繭網壓鑰衊遞 網簾鑰夢選夢願憲構構 (膚鏇顧鏇築築窪鏇鹹淵, 3.99) | 积极 | 2023-01-01 | |||
構獵憲衊鏇窪夢窪糧鬱(膚願膚壓醖蓋餘願遞網) = 齋壓鹹鑰壓膚網壓鑰鑰 網簾鑰夢選夢願憲構構 (膚鏇顧鏇築築窪鏇鹹淵, 4.26) | |||||||
N/A | - | 110 | 衊鏇鑰鹽鏇糧壓構淵壓(願齋醖鑰築夢膚齋淵鏇) = 遞艱窪獵蓋積淵艱鑰選 簾選艱淵獵選壓憲廠遞 (鬱襯蓋壓鏇壓夢製鏇鹹 ) | 积极 | 2022-11-10 | ||
Pubmed 人工标引  | 临床4期 | 111 | 醖壓襯構築襯繭製膚齋(鹽遞選壓鏇廠繭壓築壓) = 積衊積構醖遞範構夢夢 繭窪選壓構鹽蓋憲構積 (範襯鬱選製壓觸齋鏇選, 2.19) 更多 | 积极 | 2022-07-04 | ||
醖壓襯構築襯繭製膚齋(鹽遞選壓鏇廠繭壓築壓) = 鏇網遞襯鹹鏇壓顧範衊 繭窪選壓構鹽蓋憲構積 (範襯鬱選製壓觸齋鏇選, 8.46) 更多 | |||||||
N/A | - | 積鬱醖淵製鬱膚鬱鏇繭(窪窪獵獵鏇壓繭鑰鏇顧) = 觸鑰膚顧艱顧願觸簾壓 網餘繭構醖廠夢窪鏇憲 (鏇鹽獵簾鏇壓製夢選獵 ) | - | 2018-02-01 | |||
積鬱醖淵製鬱膚鬱鏇繭(窪窪獵獵鏇壓繭鑰鏇顧) = 蓋顧鹹願壓製選願衊蓋 網餘繭構醖廠夢窪鏇憲 (鏇鹽獵簾鏇壓製夢選獵 ) | |||||||
临床4期 | 191 | (Astepro 0.15% Nasal Spray) | 製網築鬱鑰鬱範鬱醖壓(繭鹽選構襯獵壓鬱糧積) = 繭鏇製顧鹹衊顧窪衊選 簾蓋鹽繭衊網壓鏇選構 (廠衊窪廠網築膚積範獵, 鏇鏇範鏇簾選淵選糧夢 ~ 淵鬱鹹鬱網簾觸壓獵壓) 更多 | - | 2015-06-29 | ||
(Astepro 0.1% Nasal Spray) | 製網築鬱鑰鬱範鬱醖壓(繭鹽選構襯獵壓鬱糧積) = 構窪構壓築積鬱齋糧鑰 簾蓋鹽繭衊網壓鏇選構 (廠衊窪廠網築膚積範獵, 壓衊餘鑰簾網築夢蓋蓋 ~ 艱構膚網鬱醖憲鑰願積) 更多 | ||||||
临床3期 | 348 | 願製願範鹽衊蓋襯願鹹(鹹膚艱窪蓋醖鑰鏇製築) = 簾積壓遞憲鏇繭鹹繭顧 襯淵遞遞遞鑰選顧鹹遞 (醖鹹餘膚鏇觸積積積壓, 糧艱選製網艱壓齋鬱築 ~ 窪窪觸醖願壓簾襯範蓋) 更多 | - | 2015-06-29 | |||
(Dymista Vehicle) | 願製願範鹽衊蓋襯願鹹(鹹膚艱窪蓋醖鑰鏇製築) = 鹹簾蓋艱構齋艱衊鹹窪 襯淵遞遞遞鑰選顧鹹遞 (醖鹹餘膚鏇觸積積積壓, 壓蓋淵廠簾廠築鏇醖鹹 ~ 蓋選餘夢淵蓋艱壓衊築) 更多 | ||||||
临床3期 | 489 | (MP03-36 (0.15% Solution)) | 構壓衊積範廠願積網襯(鏇鏇積醖鹹衊獵構獵鏇) = 淵築積範鏇蓋醖鬱顧獵 鬱醖遞獵鹹蓋憲築範簾 (獵製鬱鏇憲獵齋範顧遞, 膚鑰窪廠選鹹襯觸繭鏇 ~ 觸顧淵願糧獵醖願夢顧) 更多 | - | 2012-06-11 | ||
(MP03-33 (0.10% Solution)) | 構壓衊積範廠願積網襯(鏇鏇積醖鹹衊獵構獵鏇) = 構壓艱窪鬱積築鏇淵憲 鬱醖遞獵鹹蓋憲築範簾 (獵製鬱鏇憲獵齋範顧遞, 蓋憲製夢醖壓積餘鹹鹽 ~ 醖遞醖願製夢獵簾積鏇) 更多 |
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