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Efficacy and safety of azelastine hydrochloride and fluticasone propionate nasal spray in treating allergic rhinitis: A randomized controlled trial

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Pubmed体系：
作者：
Han Xinling[1,2,3,4] * ; Wang Chengshuo[1,2,3,4] * ; Zhang Qinna[5] * ; Guan Bing[6] * ; Zhang Hua[7] * ; Yu Yafeng[8] * ; Tang Jinyong[9] * ; Gao Xiaoping[10] * ; Meng Juan[11] * ; Li Chao[12] * ; Zhou Huifang[13] * ; Huang Xinsheng[14] * ; Shi Haiyun[15] * ; Bian Tao[16] ; Hu Guohua[17] ; Jiang Qingshan[18] ; Li Huabin[19] ; Li Lingbo[20] ; Li Xianhua[21] ; Lin Chang[22] ; Liu Dingrong[23] ; Liu Jixiang[24] ; Ma Huaan[25] ; Tan Guolin[26] ; Wan Lijia[27] ; Xia Jiao[28] ; Xiao Shuifang[29] ; Xie Jinghua[30] ; Xing Zhimin[31] ; Qu Shenhong[32] ; Zhao Changqing[33] ; Zhu Li[34] ; Zhang Yuan[1,2,3,4] ; Zhang Luo[1,2,3,4] ;
机构： [1]Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, People's Republic of China. [2]Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing, People's Republic of China. [3]Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, People's Republic of China. [4]Research Unit of Diagnosis and Treatment of Chronic Nasal Disease, Chinese Academy of Medical Sciences, Beijing, People's Republic of China. [5]Department of Otolaryngology, First Hospital of Shanxi Medical University, Taiyuan (Shanxi), People's Republic of China. [6]Department of Otolaryngology, Northern Jiangsu People's Hospital, Yangzhou (Jiangsu), People's Republic of China. [7]Department of Otolaryngology, Xinjiang Medical University Affiliated First Hospital, Urumchi (the Xinjiang Uygur Autonomous Region), People's Republic of China. [8]Department of Otolaryngology, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, People's Republic of China. [9]Department of Otolaryngology Head and Neck Surgery, Chenzhou First People's Hospital, Chenzhou, Sichuan, People's Republic of China. [10]Department of Otolaryngology Head and Neck Surgery, General Hospital of Ningxia Medical University, Yinchuan (Ningxia), China. [11]Department of Otolaryngology, West China Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China. [12]Department of Otolaryngology, The Second Hospital of Tianjin Medical University, Tianjin, People's Republic of China. [13]Department of Otolaryngology, Tianjin Medical University General Hospital, Tianjin, People's Republic of China. [14]Department of Otolaryngology, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China. [15]Department of Allergy, Beijing Shijitan Hospital, Capital Medical University, Beijing, People's Republic of China. [16]Department of Respiratory Medicine, Wuxi People's Hospital, Wuxi, Jiangsu, People's Republic of China. [17]Department of Otolaryngology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China. [18]Department of Otolaryngology, The First Affiliated Hospital of University of South China, Hengyang, Hunan, People's Republic of China. [19]Department of Otolaryngology, The Eye and Ent Hospital of Fudan University, Shanghai, People's Republic of China. [20]Department of Otolaryngology, Liuzhou Worker's Hospital, Liuzhou, Guangxi, People's Republic of China. [21]Department of Otolaryngology, Affiliated Zhongshan Hospital of Dalian University, Dalian, Liaoning, People's Republic of China. [22]Department of Otolaryngology, First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, People's Republic of China. [23]Department of Otolaryngology Head and Neck Surgery, The Second People's Hospital of Neijiang, Neijiang, Sichuan, People's Republic of China. [24]Department of Otolaryngology, Tianjin People's Hospital, Tianjin, People's Republic of China. [25]Department of Otolaryngology, Jiangsu Province Hospital of Chinese Medicine, Nanjing, Jiangsu, People's Republic of China. [26]Department of Otolaryngology, Central South University Third Xiangya Hospital, Changsha, Hunan, People's Republic of China. [27]Department of Otolaryngology, Jingzhou Central Hospital, Jingzhou, Hubei, People's Republic of China. [28]Department of Otolaryngology Head and Neck Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China. [29]Department of Otolaryngology, Peking University First Hospital, Beijing, People's Republic of China. [30]Department of Otolaryngology Head and Neck Surgery, Guangzhou First People's Hospital, Guangzhou, Guangdong, People's Republic of China. [31]Department of Otolaryngology, Peking University People's Hospital, Beijing, People's Republic of China. [32]Department of Otolaryngology Head and Neck Surgery, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, People's Republic of China. [33]Department of Otolaryngology Head and Neck Surgery, Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, People's Republic of China. [34]Department of Otolaryngology, Peking University Third Hospital, Beijing, People's Republic of China.
出处：
DOI： 10.5415/apallergy.0000000000000161
ISSN：

关键词： Allergic rhinitis Chinese equivalence trial generic drug nasal spray

摘要：
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.In this study, we evaluated whether the effect of AzeFlu, a generic drug manufactured from China, is equivalent to that of MP-AzeFlu.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.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.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).Copyright © 2024. Asia Pacific Association of Allergy, Asthma and Clinical Immunology.

语种：
外文
PubmedID：
中科院(CAS)分区：
出版当年[2025]版：
大类 | 4 区 医学
小类 | 4 区 过敏
最新[2025]版：
大类 | 4 区 医学
小类 | 4 区 过敏
第一作者：
第一作者机构： [1]Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, People's Republic of China. [2]Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing, People's Republic of China. [3]Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, People's Republic of China. [4]Research Unit of Diagnosis and Treatment of Chronic Nasal Disease, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.
共同第一作者：
通讯作者：
通讯机构： [1]Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, People's Republic of China. [2]Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing, People's Republic of China. [3]Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, People's Republic of China. [4]Research Unit of Diagnosis and Treatment of Chronic Nasal Disease, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.
推荐引用方式(GB/T 7714)：
Han Xinling,Wang Chengshuo,Zhang Qinna,et al.Efficacy and safety of azelastine hydrochloride and fluticasone propionate nasal spray in treating allergic rhinitis: A randomized controlled trial[J].Asia Pacific Allergy.2025,15(1):7-14.doi:10.5415/apallergy.0000000000000161.
APA：
Han Xinling,Wang Chengshuo,Zhang Qinna,Guan Bing,Zhang Hua...&Zhang Luo.(2025).Efficacy and safety of azelastine hydrochloride and fluticasone propionate nasal spray in treating allergic rhinitis: A randomized controlled trial.Asia Pacific Allergy,15,(1)
MLA：
Han Xinling,et al."Efficacy and safety of azelastine hydrochloride and fluticasone propionate nasal spray in treating allergic rhinitis: A randomized controlled trial".Asia Pacific Allergy 15..1(2025):7-14

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