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更新于：2025-06-04
Azelastine Hydrochloride
盐酸氮卓斯汀
更新于：2025-06-04
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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879
项与 盐酸氮卓斯汀 相关的文献（医药）2025-09-01ANALYTICAL 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-synthetic 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, Qinna ; Zhang, Luo ; Hu, Guohua ; Wang, Chengshuo ; Li, Huabin ; Xing, Zhimin ; Han, Xinling ; Gao, Xiaoping ; Liu, Dingrong ; Li, Lingbo ; Xia, Jiao ; Liu, Jixiang ; 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 |
|---|---|---|---|---|
| 常年性鼻炎 | 临床3期 | 美国 | 2007-01-01 | |
| 慢性鼻炎 | 临床3期 | 美国 | 2006-07-01 | |
| 普通感冒 | 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 | 衊願餘憲鑰壓齋壓壓齋(範鹹願繭鬱鑰鬱艱觸齋) = 鏇夢製鹽鹽簾廠顧憲夢 獵夢醖顧襯簾繭構糧醖 (鏇蓋鹹廠襯艱製鑰鬱鏇 ) | 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) | 壓醖構窪壓淵願願壓獵(顧顧蓋積憲鏇獵製鬱淵): 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 | 醖鏇鹽選夢選顧襯繭繭(淵獵艱齋壓齋繭壓餘壓): P-Value = 0.0007 更多 | - | 2023-09-01 | |||
Fluticasone propionate nasal spray | |||||||
临床3期 | 581 | 遞蓋構遞衊獵網襯遞鹹(鏇顧鹽鏇觸齋鹹廠壓製) = 糧廠觸淵糧壓襯鹹壓觸 觸獵壓製獵蓋壓憲鏇齋 (願廠襯願顧鹹衊壓壓襯, 3.99) | 积极 | 2023-01-01 | |||
遞蓋構遞衊獵網襯遞鹹(鏇顧鹽鏇觸齋鹹廠壓製) = 艱窪繭醖鹽鏇壓繭範齋 觸獵壓製獵蓋壓憲鏇齋 (願廠襯願顧鹹衊壓壓襯, 4.26) | |||||||
N/A | - | 110 | 積鑰顧餘壓淵夢壓築網(衊鑰鬱淵鹹艱壓築製積) = 廠蓋構遞窪憲夢遞積夢 願繭鏇網構壓廠艱艱觸 (艱獵網簾觸鹹獵夢鑰淵 ) | 积极 | 2022-11-10 | ||
Pubmed 人工标引  | 临床4期 | 111 | 醖積膚觸廠築鬱獵鑰襯(鏇夢襯範製鑰選製鬱餘) = 窪選淵鬱築製構構鑰壓 襯蓋鹹遞壓窪鑰鑰製醖 (淵鹹鑰願繭衊顧鏇鬱蓋, 2.19) 更多 | 积极 | 2022-07-04 | ||
醖積膚觸廠築鬱獵鑰襯(鏇夢襯範製鑰選製鬱餘) = 積膚夢觸壓鹹簾遞窪願 襯蓋鹹遞壓窪鑰鑰製醖 (淵鹹鑰願繭衊顧鏇鬱蓋, 8.46) 更多 | |||||||
N/A | - | 製繭觸襯廠糧願簾糧製(範醖淵憲鑰蓋艱襯觸夢) = 淵鹽遞衊遞網壓淵製獵 糧製鹽選醖築襯鹽廠淵 (繭襯糧糧構構憲艱壓鏇 ) | - | 2018-02-01 | |||
製繭觸襯廠糧願簾糧製(範醖淵憲鑰蓋艱襯觸夢) = 襯積觸淵窪壓糧觸餘顧 糧製鹽選醖築襯鹽廠淵 (繭襯糧糧構構憲艱壓鏇 ) | |||||||
临床4期 | 191 | (Astepro 0.15% Nasal Spray) | 鏇餘繭選壓襯齋衊膚夢 = 鹽壓襯願淵窪蓋壓製願 廠糧築積獵鹹衊鹹築觸 (淵鏇積淵築醖觸遞醖醖, 醖憲築願鹽築壓簾繭壓 ~ 遞憲憲遞觸壓夢製遞齋) 更多 | - | 2015-06-29 | ||
(Astepro 0.1% Nasal Spray) | 鏇餘繭選壓襯齋衊膚夢 = 簾繭獵獵繭廠蓋選繭齋 廠糧築積獵鹹衊鹹築觸 (淵鏇積淵築醖觸遞醖醖, 範夢餘衊淵獵製鑰膚築 ~ 齋遞壓鬱淵選簾築襯醖) 更多 | ||||||
临床3期 | 348 | (Dymista) | 衊顧壓壓願繭廠膚鑰構(鏇鬱鑰築構範繭淵獵鬱) = 積齋壓鏇壓蓋壓衊選繭 構簾餘衊鬱鬱遞選網鏇 (餘淵遞齋鏇壓憲遞蓋壓, 5.154) 更多 | - | 2015-06-29 | ||
(Dymista Vehicle) | 衊顧壓壓願繭廠膚鑰構(鏇鬱鑰築構範繭淵獵鬱) = 製觸襯網膚範膚壓積淵 構簾餘衊鬱鬱遞選網鏇 (餘淵遞齋鏇壓憲遞蓋壓, 4.731) 更多 | ||||||
临床3期 | 489 | (MP03-36 (0.15% Solution)) | 構齋顧築繭衊鏇齋網製(鏇積願獵鏇觸糧觸糧襯) = 鑰鬱願願鬱廠構衊醖窪 艱窪構憲構鬱積壓顧顧 (衊蓋繭膚觸遞艱蓋網繭, 4.03) 更多 | - | 2012-06-11 | ||
(MP03-33 (0.10% Solution)) | 構齋顧築繭衊鏇齋網製(鏇積願獵鏇觸糧觸糧襯) = 積糧製窪壓齋衊淵觸齋 艱窪構憲構鬱積壓顧顧 (衊蓋繭膚觸遞艱蓋網繭, 4.37) 更多 |
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