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

IF 1.6 Q3 ALLERGY

Asia Pacific Allergy Pub Date : 2025-03-01 Epub Date: 2024-10-29 DOI:10.5415/apallergy.0000000000000161

Xinling Han, Chengshuo Wang, Qinna Zhang, Bing Guan, Hua Zhang, Yafeng Yu, Jinyong Tang, Xiaoping Gao, Juan Meng, Chao Li, Huifang Zhou, Xinsheng Huang, Haiyun Shi, Tao Bian, Guohua Hu, Qingshan Jiang, Huabin Li, Lingbo Li, Xianhua Li, Chang Lin, Dingrong Liu, Jixiang Liu, Huaan Ma, Guolin Tan, Lijia Wan, Jiao Xia, Shuifang Xiao, Jinghua Xie, Zhimin Xing, Shenhong Qu, Changqing Zhao, Li Zhu, Yuan Zhang, Luo Zhang

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引用次数: 0

Abstract

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).

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来源期刊

Asia Pacific Allergy ALLERGY-

CiteScore

2.50

自引率

5.90%

发文量

期刊介绍： Asia Pacific Allergy (AP Allergy) is the official journal of the Asia Pacific Association of Allergy, Asthma and Clinical Immunology (APAAACI). Although the primary aim of the journal is to promote communication between Asia Pacific scientists who are interested in allergy, asthma, and clinical immunology including immunodeficiency, the journal is intended to be available worldwide. To enable scientists and clinicians from emerging societies appreciate the scope and intent of the journal, early issues will contain more educational review material. For better communication and understanding, it will include rational concepts related to the diagnosis and management of asthma and other immunological conditions. Over time, the journal will increase the number of original research papers to become the foremost citation journal for allergy and clinical immunology information of the Asia Pacific in the future.