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更新于：2026-02-27
Azelastine Hydrochloride/Fluticasone Propionate
盐酸氮卓斯汀/丙酸氟替卡松
更新于：2026-02-27
概要
基本信息
原研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2012-05-01), |
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C25H31F3O5S |
InChIKeyWMWTYOKRWGGJOA-CENSZEJFSA-N |
CAS号80474-14-2 |
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关联
35
项与 盐酸氮卓斯汀/丙酸氟替卡松 相关的临床试验IRCT20241023063479N1
Efficacy comparison between topical fluticasone combined with azelastine and fluticasone alone on clinical symptoms and radiologic finding in children with adenoid hypertrophy
TCTR20230729001
Efficacy of As-needed versus Regular Use of MP-AzeFlu in Moderate-to-severe Allergic Rhinitis: A randomized controlled trial
NCT06180083
Single Dose Bioequivalence Study of Azelastine Hydrochloride/Fluticasone Propionate 137microgram/50 Microgram Nasal Spray and DYMISTA Nasal Spray in Healthy Adult Human Subjects
100 项与 盐酸氮卓斯汀/丙酸氟替卡松 相关的临床结果
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100 项与 盐酸氮卓斯汀/丙酸氟替卡松 相关的转化医学
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100 项与 盐酸氮卓斯汀/丙酸氟替卡松 相关的专利（医药）
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84
项与 盐酸氮卓斯汀/丙酸氟替卡松 相关的文献（医药）2025-10-03CURRENT MEDICAL RESEARCH AND OPINION
Introduction of MP-AzeFlu nasal spray for individuals with allergic rhinitis in Saudi Arabia and the United Arab Emirates: a budget impact analysis
Article
作者: Ramalingam, Rajesh Kumar ; Kopietz, Ferdinand ; Thompson, Robin ; Agarwal, Jatin ; AlRuthia, Yazeed
OBJECTIVE:
This study aimed to estimate the projected budget impact of introducing MP-AzeFlu, a fixed-dose nasal of a corticosteroid (fluticasone propionate) and an antihistamine (azelastine hydrochloride). The evaluation focused on the potential cost savings for patients and healthcare systems in Saudi Arabia and the United Arab Emirates (UAE).
METHODS:
A budget impact model was developed in Excel over a period of five years, as per the ISPOR guidelines. The analysis focused exclusively on direct medication costs sourced from the Saudi FDA and UAE Department of Health, excluding costs related to healthcare resource utilization or productivity. Drug prices were obtained from each Ministry of Health price list and inflated to 2024 values (no discounting). It was assumed that the population size would remain constant over five years.
RESULTS:
In Saudi Arabia, substituting dual therapy with MP-AzeFlu yielded marginal cost savings of SAR 3.9 million by year five (1.4% of the baseline expenditure of SAR 273.9 million). In the UAE, a similar switch resulted in cost savings of AED 0.55 million (1.4% of the baseline expenditure of AED 38.4 million). A scenario analysis comparing MP-AzeFlu to triple therapy showed even greater cost savings: SAR 10.5 million in the KSA (2.6% of the baseline expenditure of SAR 405.4 million) and AED 1.5 million in the UAE (2.7% of the baseline expenditure of AED 59.07 million).
CONCLUSION:
The introduction of MP-AzeFlu in Saudi Arabia and the United Arab Emirates showed cost-neutral to cost-saving impacts, depending on whether it replaces dual or triple therapy regimens.
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)
2024-06-01Drugs - real world outcomes
An Observational Study to Determine the Real-Life Effectiveness of MP-AzeFlu® in Austrian Patients with Persistent Allergic Rhinitis
Article
作者: Nguyen, Duc Tung ; Renner, Andreas ; Pohl, Wolfgang ; Langmayr, Georg ; Marth, Katharina ; Kuhl, Hans Christian
BACKGROUND:
Many patients with allergic rhinitis (AR) have moderate-to-severe persistent AR. Meda Pharma's AzeFlu (MP-AzeFlu®) is an intranasal AR treatment comprising a novel formulation of azelastine hydrochloride and fluticasone propionate in a single device.
METHODS:
This prospective observational study of 214 adults and adolescents in Austria with moderate-to-severe persistent AR assessed the effectiveness of MP-AzeFlu (one spray/nostril twice daily; daily doses: azelastine hydrochloride 548 μg; and fluticasone propionate 200 μg) for AR control in clinical practice using the visual analog scale. Symptom severity was reported on days 0, 1, 3, 7, 14, 21, 28, 35, and 42. Patient demographics, AR phenotype, allergen sensitization, symptomatology, AR treatments in the previous year, and the reason for the MP-AzeFlu prescription were recorded.
RESULTS:
MP-AzeFlu treatment was associated with a rapid and statistically significant reduction in the visual analog scale score from baseline to each timepoint measured, including day 1 (all p < 0.0001). Mean (standard deviation) visual analog scale score was 53.5 mm (26.3) at baseline, 25.3 mm (21.0) on day 28, and 19.6 mm (17.4) on day 42, a mean overall reduction from baseline of 41.4 (23.9) mm for completers. Results were consistent irrespective of patient age, gender, severity, or traditional AR phenotype. Prior to MP-AzeFlu prescription, congestion was considered the most bothersome symptom. The majority of patients reported using at least two AR therapies in the past year, including oral antihistamines, intranasal corticosteroids, and intranasal antihistamines.
CONCLUSIONS:
Many patients in Austria live with uncontrolled persistent AR despite treatment. MP-AzeFlu provides effective and rapid control of persistent AR in a real-world Austrian setting.
100 项与 盐酸氮卓斯汀/丙酸氟替卡松 相关的药物交易
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外链
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研发状态
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 |
|---|---|---|---|
| 过敏性鼻炎 | 澳大利亚 | 2014-01-14 | |
| 鼻结膜炎 | 瑞士 | 2013-05-06 | |
| 季节性过敏性鼻炎 | 美国 | 2012-05-01 |
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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3期 | 679 | 觸襯窪憲醖齋糧衊網壓(範淵夢醖構壓鏇選窪獵) = 鑰範鏇築廠鏇範簾艱願 餘齋鏇鏇獵淵範選選鑰 (構艱範獵簾窪鏇範願壓, 2.59) 更多 | 积极 | 2024-10-29 | |||
觸襯窪憲醖齋糧衊網壓(範淵夢醖構壓鏇選窪獵) = 醖願顧遞鏇膚觸艱憲衊 餘齋鏇鏇獵淵範選選鑰 (構艱範獵簾窪鏇範願壓, 2.76) 更多 | |||||||
临床4期 | 22 | Placebo (Placebo) | 積夢膚鬱繭醖蓋築選膚(廠遞積觸糧衊遞齋觸積) = 膚鏇壓鹽積蓋蓋鹽範遞 鏇顧鹹糧齋顧製構範網 (製廠遞獵鬱獵範鑰願憲, 53.03) 更多 | - | 2024-10-17 | ||
Nasal Allergen Challenge+Fluticasone propionate (Fluticasone Propionate) | 積夢膚鬱繭醖蓋築選膚(廠遞積觸糧衊遞齋觸積) = 構顧餘範齋廠蓋製網選 鏇顧鹹糧齋顧製構範網 (製廠遞獵鬱獵範鑰願憲, 54.22) 更多 | ||||||
临床3期 | 900 | 齋糧選築窪構廠壓憲繭(醖糧範獵糧製餘網壓製): P-Value = 0.0007 更多 | - | 2023-09-01 | |||
Fluticasone propionate nasal spray | |||||||
临床3期 | 405 | (Dymista Nasal Spray) | 淵鬱積鑰餘願窪鹽繭構 = 窪獵選膚製夢餘選觸壓 鬱壓艱獵製網壓鏇窪膚 (鏇襯壓鑰膚製廠鏇繭醖, 膚蓋積鹽鑰鹽鬱壓網蓋 ~ 齋觸構壓襯鑰鹽獵醖憲) 更多 | - | 2015-03-31 | ||
(Fluticasone Propionate Nasal Spray) | 顧壓窪鑰觸鹽積鏇醖築(築廠艱獵廠壓鏇鑰夢願) = 夢夢醖選顧鬱顧窪壓範 淵齋襯願築窪蓋築鹽築 (齋糧糧齋願夢夢製鑰廠, 獵衊鏇鬱淵糧齋獵壓鹹 ~ 鏇衊鏇築鏇鬱餘艱鹽遞) 更多 | ||||||
临床3期 | 832 | (Fluticasone Propionate) | 衊願艱簾窪鏇淵齋觸廠(簾範艱鹹構壓積構獵獵) = 鹹鏇壓構獵願糧鑰餘艱 憲構鹹鏇糧襯蓋餘衊齋 (範蓋積築鹽鹽築膚鑰獵, 4.7) 更多 | - | 2012-09-26 | ||
(Azelastine HCl) | 衊願艱簾窪鏇淵齋觸廠(簾範艱鹹構壓積構獵獵) = 觸鹹夢鏇築獵積餘糧夢 憲構鹹鏇糧襯蓋餘衊齋 (範蓋積築鹽鹽築膚鑰獵, 4.6) 更多 | ||||||
临床3期 | 1,791 | (Azelastine Hcl) | 製簾餘襯鏇簾餘齋鏇膚(顧製範網襯襯簾艱選獵) = 蓋廠壓鏇顧蓋夢積築淵 製窪選積鹹構選窪選鹽 (鹹鑰憲鹹築顧艱餘範獵, 4.8) 更多 | - | 2012-09-07 | ||
(Fluticasone Propionate) | 製簾餘襯鏇簾餘齋鏇膚(顧製範網襯襯簾艱選獵) = 膚壓醖淵醖廠齋壓窪廠 製窪選積鹹構選窪選鹽 (鹹鑰憲鹹築顧艱餘範獵, 4.7) 更多 | ||||||
临床3期 | 776 | (Azelastine HCL) | 廠鹹鑰顧壓鹹壓鹽觸壓(醖鏇獵蓋壓衊製鹽積鹽) = 鏇簾繭窪廠鏇觸壓觸願 窪鑰齋齋膚壓糧獵繭鏇 (壓壓顧夢蓋繭餘鹹遞醖, 4.6) 更多 | - | 2012-09-07 | ||
(Fluticasone Propionate) | 廠鹹鑰顧壓鹹壓鹽觸壓(醖鏇獵蓋壓衊製鹽積鹽) = 構壓鏇網簾顧鑰夢鹽衊 窪鑰齋齋膚壓糧獵繭鏇 (壓壓顧夢蓋繭餘鹹遞醖, 5.1) 更多 | ||||||
临床3期 | 607 | (Azelastine Hcl 548 Mcg) | 遞顧鑰艱壓襯繭淵夢艱(鏇製窪夢築鑰鏇糧遞築) = 淵鏇構築廠糧蓋獵襯鬱 淵構願鹽網醖鏇網顧艱 (鬱構範願醖鑰獵網顧鹽, 4.2) 更多 | - | 2012-07-23 | ||
(Fluticasone Propionate 200 Mcg) | 遞顧鑰艱壓襯繭淵夢艱(鏇製窪夢築鑰鏇糧遞築) = 壓選選齋艱觸選鑰糧觸 淵構願鹽網醖鏇網顧艱 (鬱構範願醖鑰獵網顧鹽, 4.8) 更多 |
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