一项在中国变应性鼻炎志愿者中评估MP-氮卓斯汀氟替卡松鼻喷雾剂与市售盐酸氮卓斯汀和丙酸氟替卡松鼻喷雾剂相比的疗效和安全性的临床研究。
A Clinical Study to Assess the Efficacy and Safety of MP-AzeFlu Nasal Spray in Comparison to Commercially Available Azelastine Hydrochloride and Fluticasone Propionate Nasal Sprays in Chinese Volunteers with Allergic Rhinitis.
作者信息
Zhou Bing, Cheng Lei, Pan Jing, Wang Huizhong, Jin Yongde, Zhao Changqing, Lin Peng, Tan Guolin, Fang Hongyan, Zhang Hua, Zhou Huifang, Dong Yaowu, Kuhl Hans Christian, Ramalingam Rajesh Kumar, Nguyen Duc Tung
机构信息
Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, 100051, China.
Department of Otorhinolaryngology & Clinical Allergy Center, The First Affiliated Hospital, Nanjing Medical University, Nanjing, 210029, China.
出版信息
Pulm Ther. 2023 Sep;9(3):411-427. doi: 10.1007/s41030-023-00238-8. Epub 2023 Aug 14.
INTRODUCTION
The objective of the present study was to evaluate the efficacy and safety of MP-AzeFlu nasal spray in comparison to commercially available azelastine hydrochloride and fluticasone propionate sprays in Chinese patients with moderate-to-severe allergic rhinitis (AR).
METHODS
We conducted a 14-day multicenter, randomized, double-blind, active controlled prospective clinical study in adult and adolescent patients with AR, who had moderate-to-severe symptoms. The primary efficacy endpoint was the change from baseline in combined 12-h reflective total nasal symptom score (rTNSS) (morning [AM] + afternoon [PM]). The safety profile of the study medications was assessed through the recording, reporting, and analysis of baseline medical conditions, adverse events (AEs), vital signs, and focused nasal examination. Three hundred patients per treatment group were randomized, which led to a total sample size estimation of 900 patients.
RESULTS
MP-AzeFlu group showed significantly higher symptom reduction for the entire 2-week treatment period in rTNSS when compared with the AZE group (LS mean difference: - 1.96; 95% CI: - 2.53, - 1.39; p < 0.0001), or the FLU group (LS mean difference: - 0.98; 95% CI: - 1.55, - 0.41; p = 0.0007). The results of adult RQLQ showed improvement in QoL in all treatment groups. Except for dysgeusia (bitter taste) that was reported by more patients (13 [4.3%]) in the MP-AzeFlu group, the incidence of all other TEAEs in the MP-AzeFlu group was comparable or even lower than in other treatment groups.
CONCLUSIONS
MP-AzeFlu, when administered as one spray per nostril twice daily for 14 days, alleviated AR symptoms in Chinese patients with moderate-to-severe AR.
TRIAL REGISTRATION
Clinicaltrials.gov; NCT03599791, Registered June 29, 2018, retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03599791 .
引言
本研究的目的是评估MP-AzeFlu鼻喷雾剂与市售盐酸氮卓斯汀和丙酸氟替卡松喷雾剂相比，对中国中重度过敏性鼻炎（AR）患者的疗效和安全性。
方法
我们对有中重度症状的成年和青少年AR患者进行了一项为期14天的多中心、随机、双盲、活性对照前瞻性临床研究。主要疗效终点是联合12小时反射性总鼻症状评分（rTNSS）（上午[AM]+下午[PM]）相对于基线的变化。通过记录、报告和分析基线医疗状况、不良事件（AE）、生命体征和重点鼻检查来评估研究药物的安全性。每个治疗组随机分配300名患者，总样本量估计为900名患者。
结果
与AZE组相比，MP-AzeFlu组在整个2周治疗期内rTNSS症状减轻显著更高（最小二乘均值差异：-1.96；95%置信区间：-2.53，-1.39；p<0.0001），或与FLU组相比（最小二乘均值差异：-0.98；95%置信区间：-1.55，-0.41；p=0.0007）。成人RQLQ结果显示所有治疗组的生活质量均有改善。除MP-AzeFlu组有更多患者（13[4.3%]）报告味觉障碍（苦味）外，MP-AzeFlu组所有其他TEAE的发生率与其他治疗组相当甚至更低。
结论
MP-AzeFlu每日每侧鼻孔喷雾一次，持续14天，可缓解中国中重度AR患者的AR症状。
试验注册
Clinicaltrials.gov；NCT03599791，2018年6月29日注册，追溯注册，https://clinicaltrials.gov/ct2/show/NCT03599791 。
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