DYmista NAsal Spray in CHInese Patients

Phase 3 Completed 900 enrolled MEDA Pharma GmbH & Co. KG

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a phase III clinical study to assess the efficacy and safety of Dymista® Nasal Spray in comparison to Azep® nasal spray and Flixonase® nasal spray in Chinese patients aged ≥ 12 years with moderate-to-severe allergic rhinitis/rhinoconjunctivitis.

Timeline

Start: 2018-06-29
Primary completion: 2019-09-24
Completion: 2019-09-24

Publications

Zhou B, Cheng L, Pan J, Wang H, Jin Y, Zhao C, Lin P, Tan G, Fang H, Zhang H, Zhou H, Dong Y, Kuhl HC, Ramalingam RK, Nguyen DT. 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. Epub 2023 Aug 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Azelastine	Small molecule	0.137 mg	Intranasal
Subject	Azelastine Hydrochl./Fluticasone Prop.	Unknown	0.05 mg	Intranasal
Subject	Azelastine Hydrochl./Fluticasone Prop.	Unknown	0.137 mg	Intranasal
Comparator	Fluticasone propionate	Other / unclassified	0.05 mg	Intranasal

DYmista NAsal Spray in CHInese Patients

Summary

Timeline

Publications

Drugs

Indications