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
机构：[1]Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing 100051, China临床科室耳鼻咽喉-头颈外科首都医科大学附属北京同仁医院首都医科大学附属同仁医院[2]Department of Otorhinolaryngology & Clinical Allergy Center, The First Affiliated Hospital, Nanjing Medical University, Nanjing, 210029, China江苏省人民医院[3]Department of Otolaryngology Head and Neck Surgery, Tianjing Renmin Hospital, Nankai University, Tianjing, China[4]Department of Otolaryngology Head and Neck Surgery, Zibo Central Hospital, Zibo, China[5]Department of Otolaryngology Head and Neck Surgery, Yanbian University Hospital, Yanji, China[6]Departments of Otolaryngology Head and Neck Surgery, Second Affiliated Hospital, Shanxi Medical University, Taiyuan, China[7]Department of Otolaryngology Head Neck Surgery, Tianjin First Central Hospital, Tianjin Medical University, Tianjin, China[8]Department of Otolaryngology Head Neck Surgery, Third Xiangya Hospital, Central South University, Changsha, China[9]Department of Otolaryngology Head Neck Surgery, Chongqing General Hospital, Chongqing, China[10]Department of Otolaryngology Head Neck Surgery, The first affiliated Hospital of Xinjiang Medical University, Wulumuqi, China[11]Department of Otolaryngology Head Neck Surgery, Tianjin Medical University General Hospital, Tianjin, China[12]Department of Otolaryngology Head Neck Surgery, Tonghua Central Hospital, Tonghua, China[13]Global Clinical Sciences, MEDA Pharma GmbH & Co. KG (A Viatris Company), Bad Homburg, Germany[14]Mylan Pharmaceuticals Private Limited (Now Viatris), Bengaluru, India[15]International Centre for Allergy Research, Nanjing Medical University, Nanjing, 210029, China[16]Biometrics, MEDA Pharma GmbH & Co. KG (A Viatris Company), Bad Homburg, Germany
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.
基金：
The present study and the journal’s Rapid Service Fee were funded by MEDA
Pharma GmbH & Co. KG (a Mylan Company)
now Viatris.
第一作者机构：[1]Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing 100051, China
通讯作者：
推荐引用方式(GB/T 7714)：
Bing Zhou,Lei Cheng,Jing Pan,et al.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[J].PULMONARY THERAPY.2023,9(3):411-427.doi:10.1007/s41030-023-00238-8.
APA：
Bing Zhou,Lei Cheng,Jing Pan,Huizhong Wang,Yongde Jin...&Duc Tung Nguyen.(2023).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.PULMONARY THERAPY,9,(3)
MLA：
Bing Zhou,et al."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".PULMONARY THERAPY 9..3(2023):411-427
