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  3. 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

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

  • Pulm Ther. 2023 Sep;9(3):411-427. doi: 10.1007/s41030-023-00238-8.
Bing Zhou 1,  Lei Cheng 2 3,  Jing Pan 4,  Huizhong Wang 5,  Yongde Jin 6,  Changqing Zhao 7,  Peng Lin 8,  Guolin Tan 9,  Hongyan Fang 10,  Hua Zhang 11,  Huifang Zhou 12,  Yaowu Dong 13,  Hans Christian Kuhl 14,  Rajesh Kumar Ramalingam 15,  Duc Tung Nguyen 16
Affiliations

Affiliations

  • 1 Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, 100051, China. entzhou@263.net.
  • 2 Department of Otorhinolaryngology & Clinical Allergy Center, The First Affiliated Hospital, Nanjing Medical University, Nanjing, 210029, China.
  • 3 International Centre for Allergy Research, Nanjing Medical University, Nanjing, 210029, China.
  • 4 Department of Otolaryngology Head and Neck Surgery, Tianjing Renmin Hospital, Nankai University, Tianjing, China.
  • 5 Department of Otolaryngology Head and Neck Surgery, Zibo Central Hospital, Zibo, China.
  • 6 Department of Otolaryngology Head and Neck Surgery, Yanbian University Hospital, Yanji, China.
  • 7 Departments of Otolaryngology Head and Neck Surgery, Second Affiliated Hospital, Shanxi Medical University, Taiyuan, China.
  • 8 Department of Otolaryngology Head Neck Surgery, Tianjin First Central Hospital, Tianjin Medical University, Tianjin, China.
  • 9 Department of Otolaryngology Head Neck Surgery, Third Xiangya Hospital, Central South University, Changsha, China.
  • 10 Department of Otolaryngology Head Neck Surgery, Chongqing General Hospital, Chongqing, China.
  • 11 Department of Otolaryngology Head Neck Surgery, The first affiliated Hospital of Xinjiang Medical University, Wulumuqi, China.
  • 12 Department of Otolaryngology Head Neck Surgery, Tianjin Medical University General Hospital, Tianjin, China.
  • 13 Department of Otolaryngology Head Neck Surgery, Tonghua Central Hospital, Tonghua, China.
  • 14 Biometrics, MEDA Pharma GmbH & Co. KG (A Viatris Company), Bad Homburg, Germany.
  • 15 Mylan Pharmaceuticals Private Limited (Now Viatris), Bengaluru, India.
  • 16 Global Clinical Sciences, MEDA Pharma GmbH & Co. KG (A Viatris Company), Bad Homburg, Germany.
PMID: 37580498 DOI: 10.1007/s41030-023-00238-8
Abstract

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 .

Keywords

Allergic rhinitis; Azelastine; Fixed-dose combination; Fluticasone; Seasonal allergic rhinitis.

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