PMID- 37580498
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231217
IS  - 2364-1746 (Electronic)
IS  - 2364-1754 (Print)
IS  - 2364-1754 (Linking)
VI  - 9
IP  - 3
DP  - 2023 Sep
TI  - 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.
PG  - 411-427
LID - 10.1007/s41030-023-00238-8 [doi]
AB  - 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 .
CI  - (c) 2023. The Author(s).
FAU - Zhou, Bing
AU  - Zhou B
AD  - Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, 
      Capital Medical University, Beijing, 100051, China. entzhou@263.net.
FAU - Cheng, Lei
AU  - Cheng L
AD  - Department of Otorhinolaryngology & Clinical Allergy Center, The First Affiliated 
      Hospital, Nanjing Medical University, Nanjing, 210029, China.
AD  - International Centre for Allergy Research, Nanjing Medical University, Nanjing, 
      210029, China.
FAU - Pan, Jing
AU  - Pan J
AD  - Department of Otolaryngology Head and Neck Surgery, Tianjing Renmin Hospital, 
      Nankai University, Tianjing, China.
FAU - Wang, Huizhong
AU  - Wang H
AD  - Department of Otolaryngology Head and Neck Surgery, Zibo Central Hospital, Zibo, 
      China.
FAU - Jin, Yongde
AU  - Jin Y
AD  - Department of Otolaryngology Head and Neck Surgery, Yanbian University Hospital, 
      Yanji, China.
FAU - Zhao, Changqing
AU  - Zhao C
AD  - Departments of Otolaryngology Head and Neck Surgery, Second Affiliated Hospital, 
      Shanxi Medical University, Taiyuan, China.
FAU - Lin, Peng
AU  - Lin P
AD  - Department of Otolaryngology Head Neck Surgery, Tianjin First Central Hospital, 
      Tianjin Medical University, Tianjin, China.
FAU - Tan, Guolin
AU  - Tan G
AD  - Department of Otolaryngology Head Neck Surgery, Third Xiangya Hospital, Central 
      South University, Changsha, China.
FAU - Fang, Hongyan
AU  - Fang H
AD  - Department of Otolaryngology Head Neck Surgery, Chongqing General Hospital, 
      Chongqing, China.
FAU - Zhang, Hua
AU  - Zhang H
AD  - Department of Otolaryngology Head Neck Surgery, The first affiliated Hospital of 
      Xinjiang Medical University, Wulumuqi, China.
FAU - Zhou, Huifang
AU  - Zhou H
AD  - Department of Otolaryngology Head Neck Surgery, Tianjin Medical University 
      General Hospital, Tianjin, China.
FAU - Dong, Yaowu
AU  - Dong Y
AD  - Department of Otolaryngology Head Neck Surgery, Tonghua Central Hospital, 
      Tonghua, China.
FAU - Kuhl, Hans Christian
AU  - Kuhl HC
AD  - Biometrics, MEDA Pharma GmbH & Co. KG (A Viatris Company), Bad Homburg, Germany.
FAU - Ramalingam, Rajesh Kumar
AU  - Ramalingam RK
AD  - Mylan Pharmaceuticals Private Limited (Now Viatris), Bengaluru, India.
FAU - Nguyen, Duc Tung
AU  - Nguyen DT
AD  - Global Clinical Sciences, MEDA Pharma GmbH & Co. KG (A Viatris Company), Bad 
      Homburg, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT03599791
PT  - Journal Article
DEP - 20230814
PL  - United States
TA  - Pulm Ther
JT  - Pulmonary therapy
JID - 101687144
EIN - Pulm Ther. 2024 Mar;10(1):143-144. PMID: 38099987
PMC - PMC10447793
OTO - NOTNLM
OT  - Allergic rhinitis
OT  - Azelastine
OT  - Fixed-dose combination
OT  - Fluticasone
OT  - Seasonal allergic rhinitis
COIS- Duc Tung Nguyen, Hans Christian Kuhl, and Rajesh Kumar R, are employees of 
      Viatris. Bing Zhou, Lei Cheng, Jing Pan, Huizhong Wang, Yongde Jin, Changqing 
      Zhao, Peng Lin, Goulin Tan, Hongyan Fang, Hua Zhang, Huifang Zhou, and Yaowu Dong 
      have no other competing interests to declare.
EDAT- 2023/08/15 00:42
MHDA- 2023/08/15 00:43
PMCR- 2023/08/14
CRDT- 2023/08/14 23:27
PHST- 2023/05/25 00:00 [received]
PHST- 2023/07/07 00:00 [accepted]
PHST- 2023/08/15 00:43 [medline]
PHST- 2023/08/15 00:42 [pubmed]
PHST- 2023/08/14 23:27 [entrez]
PHST- 2023/08/14 00:00 [pmc-release]
AID - 10.1007/s41030-023-00238-8 [pii]
AID - 238 [pii]
AID - 10.1007/s41030-023-00238-8 [doi]
PST - ppublish
SO  - Pulm Ther. 2023 Sep;9(3):411-427. doi: 10.1007/s41030-023-00238-8. Epub 2023 Aug 
      14.