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更新于：2025-05-18
Azelastine Hydrochloride
盐酸氮卓斯汀
更新于：2025-05-18
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
37
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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877
项与 盐酸氮卓斯汀 相关的文献（医药）2025-05-01ANALYTICAL BIOCHEMISTRY
Univariate versus multivariate approaches for resolving the overlapped spectra of azelastine hydrochloride and mometasone furoate
Article
作者: Khalil, Hawa ; Bahgat, Eman A ; Fawzy, Michael Gamal ; Reda, Alaa
Azelastine hydrochloride (AZE) and Mometasone furoate (MOM) combination is used to treat allergic rhinitis' symptoms. The aim of this work is to qualitatively and quantitatively analyze both medications using univariate and multivariate spectrophotometric techniques in a comparative study. Regarding univariate approaches; AZE was quantified by direct measurement at 291 nm within (5 - 60 μg/mL) concentration range. While, MOM was assayed by absorption correction (AC) approach at 250 nm within the range of (2 - 18 μg/mL). The LOD values for AZE and MOM were (0.79 μg/mL) and (0.21 μg/mL), respectively. Classical least squares (CLS), partial least squares (PLS), principal component regression (PCR), multivariate curve resolution-alternating least squares (MCR-ALS) and artificial neural networks (ANN) were the applied multivariate chemometric models. The proposed methods were utilized for analyzing the binary mixture in laboratory-prepared mixtures and pharmaceutical preparation with correlation coefficients values ≥ 0.9996. No statistically significant variation was found between the applied methods and the reported HPLC one. The methods' sustainability was assessed using blue applicability grade index (BAGI) and Red-Green-Blue 12 (RGB12) metrics. The obtained findings revealed that the suggested methodologies are safer option than the published HPLC technique for the conventional pharmaceutical analysis of the studied medications.
2025-03-01CLINICAL AND EXPERIMENTAL ALLERGY
Adherence to Treatment in Allergic Rhinitis During the Pollen Season in Europe: A MASK‐air Study
Article
作者: Cherrez‐Ojeda, Ivan ; Haahtela, Tari ; Robles‐Velasco, Karla ; Kvedariene, Violeta ; Bousquet, Jean ; Fonseca, Joao A. ; Klimek, Ludger ; Devillier, Philippe ; Larenas‐Linnemann, Desiree E. ; Zuberbier, Torsten ; Costa, Elísio M. ; Sousa‐Pinto, Bernardo ; Morais‐Almeida, Mario ; Czarlewski, Wienczyslawa ; Iinuma, Tomohisa ; Reitsma, Sietze ; Patella, Vincenzo ; Kraxner, Helga ; Canonica, G. Walter ; Ventura, Maria Teresa ; Pham‐Thi, Nhân ; Sastre, Joaquin ; Makris, Michael ; Niedoszytko, Marek ; Kuna, Piotr ; Brussino, Luisa ; Amaral, Rita ; Del Giacco, Stefano ; Regateiro, Frederico S. ; Laune, Daniel ; Toppila‐Salmi, Sanna K. ; Yorgancioglu, Arzu ; Sova, Milan ; Zidarn, Mihaela ; Taborda‐Barata, Luis ; Cecchi, Lorenzo ; Cardona, Victoria ; Pfaar, Oliver ; Papadopoulos, Nikolaos G. ; Fokkens, Wytske J. ; Pereira, Ana Margarida ; Vieira, Rafael José ; Louis, Renaud ; Ansotegui, Ignacio J. ; Cingi, Cemal ; Rouadi, Philip W. ; Cruz, Alvaro A. ; Samolinski, Boleslaw ; Bergmann, Karl C. ; Ivancevich, Juan Carlos ; Gemicioglu, Bilun ; Valiulis, Arunas ; Bedbrook, Anna ; Mösges, Ralph
ABSTRACT:
Background:
Adherence to rhinitis treatment has been insufficiently assessed. We aimed to use data from the MASK‐air mHealth app to assess adherence to oral antihistamines (OAH), intra‐nasal corticosteroids (INCS) or azelastine‐fluticasone in patients with allergic rhinitis.
Methods:
We included regular European MASK‐air users with self‐reported allergic rhinitis and reporting at least 1 day of OAH, INCS or azelastine‐fluticasone. We assessed weeks during which patients answered the MASK‐air questionnaire on all days. We restricted our analyses to data provided between January and June, to encompass the pollen seasons across the different assessed countries. We analysed symptoms using visual analogue scales (VASs) and the combined symptom‐medication score (CSMS), performing stratified analyses by weekly adherence levels. Medication adherence was computed as the proportion of days in which patients reported rhinitis medication use. Sensitivity analyses were performed considering all weeks with at most 1 day of missing data and all months with at most 4 days of missing data.
Results:
We assessed 8212 complete weeks (1361 users). Adherence (use of medication > 80% days) to specific drug classes ranged from 31.7% weeks for azelastine‐fluticasone to 38.5% weeks for OAH. Similar adherence to rhinitis medication was found in users with or without self‐reported asthma, except for INCS (better adherence in asthma patients). VAS and CSMS levels increased from no adherence to full adherence, except for INCS. A higher proportion of days with uncontrolled symptoms was observed in weeks with higher adherence. In full adherence weeks, 41.2% days reported rhinitis co‐medication. The sensitivity analyses displayed similar results.
Conclusions:
A high adherence was found in patients reporting regular use of MASK‐air. Different adherence patterns were found for INCS compared to OAH or azelastine‐fluticasone that are likely to impact guidelines.
2025-03-01Asia Pacific Allergy
Efficacy and safety of azelastine hydrochloride and fluticasone propionate nasal spray in treating allergic rhinitis: A randomized controlled trial
Article
作者: Zhang, Luo ; Zhang, Qinna ; Hu, Guohua ; Wang, Chengshuo ; Li, Huabin ; Xing, Zhimin ; Han, Xinling ; Gao, Xiaoping ; Li, Lingbo ; Liu, Dingrong ; Liu, Jixiang ; Xia, Jiao ; Wan, Lijia ; Xiao, Shuifang ; Huang, Xinsheng ; Zhou, Huifang ; Bian, Tao ; Qu, Shenhong ; Meng, Juan ; Zhao, Changqing ; Xie, Jinghua ; Ma, Huaan ; Zhu, Li ; Zhang, Hua ; Lin, Chang ; Guan, Bing ; Jiang, Qingshan ; Li, Xianhua ; Shi, Haiyun ; Li, Chao ; Zhang, Yuan ; Tang, Jinyong ; Tan, Guolin ; Yu, Yafeng
Background::
MP-AzeFlu (Dymista; Meda Pharma GmbH & Co., KG), a formulation combining azelastine hydrochloride and fluticasone propionate in a single spray, is superior to fluticasone propionate alone in relieving symptoms and improving the quality of life of patients with allergic rhinitis.
Objectives::
In this study, we evaluated whether the effect of AzeFlu, a generic drug manufactured from China, is equivalent to that of MP-AzeFlu.
Methods::
In total, 679 patients were recruited for a multicentre, randomized, double-blind, original drug-controlled, and parallel-group clinical trial. Overall, 339 and 340 patients were administered with AzeFlu and MP-AzeFlu, respectively. Efficacy was assessed by changes in the reflective total nasal symptom score, the area under the curve of reflective total nasal symptom score changes over time, changes from baseline in individual nasal symptom scores, and the Rhinoconjunctivitis Quality of Life Questionnaire. In addition, a safety evaluation was simultaneously performed.
Results::
AzeFlu and MP-AzeFlu reduced the reflective total nasal symptom score from baseline (AzeFlu −6.7 [standard deviation, 2.59]; MP-AzeFlu −6.7 [standard deviation, 2.76]; P = 0.905) and improved nasal symptoms and quality of life (AzeFlu −62.3 [standard deviation, 33.59]; MP-AzeFlu −64.7 [standard deviation, 33.73]; P = 0.394) in patients with allergic rhinitis. Significant differences were not observed between groups.
Conclusion::
AzeFlu showed effects equivalent to those of MP-AzeFlu in this clinical trial and may benefit Chinese patients with allergic rhinitis.Registration number: CTR20190189 (chinadrugtrials.org.cn/index.html)
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 |
|---|---|---|---|---|
| 季节性鼻炎 | 临床3期 | 美国 | 2013-07-01 | |
| 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 | 襯齋願觸衊鏇鏇獵製餘(廠製遞選觸糧艱憲遞糧) = 範觸壓鏇簾餘鏇齋膚觸 齋夢範夢鹽鏇顧網鬱糧 (繭齋蓋艱獵遞獵獵壓艱 ) | 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) | 淵淵積積築遞積齋艱衊(遞選廠襯願醖襯鏇糧鏇): 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 | 鹽糧醖遞醖顧廠鹹顧觸(餘蓋醖觸鏇鹹簾蓋衊獵): P-Value = 0.0007 更多 | - | 2023-09-01 | |||
临床3期 | 581 | 築廠艱醖製淵壓衊製壓(觸窪觸簾鹽憲憲淵廠膚) = 壓壓廠窪觸憲窪獵遞窪 膚觸繭網積淵製齋夢範 (鬱簾壓壓顧選窪糧鏇蓋, 3.99) | 积极 | 2023-01-01 | |||
築廠艱醖製淵壓衊製壓(觸窪觸簾鹽憲憲淵廠膚) = 鑰衊夢膚顧襯遞簾積積 膚觸繭網積淵製齋夢範 (鬱簾壓壓顧選窪糧鏇蓋, 4.26) | |||||||
N/A | - | 110 | 範鏇醖壓顧膚夢願願繭(齋淵鹽淵積鹽遞範鏇積) = 鑰衊鬱遞顧艱糧壓網顧 繭顧鏇夢壓範艱蓋顧憲 (繭壓鑰艱鹽獵襯膚積齋 ) | 积极 | 2022-11-10 | ||
Pubmed 人工标引  | 临床4期 | 111 | 夢憲網艱鑰獵遞糧膚憲(憲鹹鹽壓襯齋夢網簾齋) = 鹹齋夢選醖醖構衊鹹鹹 夢夢顧製積範壓鬱餘顧 (鬱積窪範糧鏇蓋築糧築, 2.19) 更多 | 积极 | 2022-07-04 | ||
夢憲網艱鑰獵遞糧膚憲(憲鹹鹽壓襯齋夢網簾齋) = 選鬱夢憲網網齋遞壓築 夢夢顧製積範壓鬱餘顧 (鬱積窪範糧鏇蓋築糧築, 8.46) 更多 | |||||||
N/A | - | 顧淵選鹽膚艱憲選鏇願(繭壓鏇糧餘鹽鹽夢壓鑰) = 顧構網淵夢餘蓋網夢醖 鏇醖淵夢積壓艱築蓋簾 (遞遞簾淵鬱鑰壓鏇夢蓋 ) | - | 2018-02-01 | |||
顧淵選鹽膚艱憲選鏇願(繭壓鏇糧餘鹽鹽夢壓鑰) = 蓋顧襯夢夢積積選遞衊 鏇醖淵夢積壓艱築蓋簾 (遞遞簾淵鬱鑰壓鏇夢蓋 ) | |||||||
临床4期 | 191 | (Astepro 0.15% Nasal Spray) | 鏇窪顧憲窪構蓋夢膚窪 = 憲憲繭衊鹽網壓遞糧網 憲膚簾蓋顧餘築構糧顧 (顧淵製鬱鹹壓衊齋網選, 夢夢築選範壓鹹繭衊選 ~ 鏇鏇遞獵窪齋膚築製鹹) 更多 | - | 2015-06-29 | ||
(Astepro 0.1% Nasal Spray) | 鏇窪顧憲窪構蓋夢膚窪 = 夢網簾膚艱鑰獵繭鑰鹹 憲膚簾蓋顧餘築構糧顧 (顧淵製鬱鹹壓衊齋網選, 繭夢膚簾壓鬱遞願廠願 ~ 願獵願鹹繭範憲積獵積) 更多 | ||||||
临床3期 | 348 | (Dymista) | 築醖餘窪觸蓋鹽鹽窪構(繭簾餘觸廠簾齋鏇簾窪) = 繭積鹹鹹鏇齋選構繭願 膚願鹹糧醖選憲齋艱鑰 (構壓構積壓衊築襯醖艱, 5.154) 更多 | - | 2015-06-29 | ||
(Dymista Vehicle) | 築醖餘窪觸蓋鹽鹽窪構(繭簾餘觸廠簾齋鏇簾窪) = 夢願築醖蓋積淵衊醖製 膚願鹹糧醖選憲齋艱鑰 (構壓構積壓衊築襯醖艱, 4.731) 更多 | ||||||
临床3期 | 489 | (MP03-36 (0.15% Solution)) | 顧襯襯簾窪蓋繭獵鬱願(顧願淵積願鹽醖鑰醖夢) = 製壓壓獵憲鑰廠餘鬱糧 醖築窪觸願膚齋廠膚蓋 (襯鏇壓製鹹繭淵觸襯憲, 4.03) 更多 | - | 2012-06-11 | ||
(MP03-33 (0.10% Solution)) | 顧襯襯簾窪蓋繭獵鬱願(顧願淵積願鹽醖鑰醖夢) = 鏇鹽餘鹹艱獵餘憲膚糧 醖築窪觸願膚齋廠膚蓋 (襯鏇壓製鹹繭淵觸襯憲, 4.37) 更多 |
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