DYmista NAsal Spray in CHInese Patients (DYNAS-CHI)
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|ClinicalTrials.gov Identifier: NCT03599791|
Recruitment Status : Completed
First Posted : July 26, 2018
Last Update Posted : February 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Allergic Rhinitis||Drug: Azelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUAT Drug: Azelastine Hydrochloride 0.137 MG/ACTUAT Drug: Fluticasone Propionate 0.05 MG/ACTUAT||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||900 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Multicentre, randomized, double-blind, active controlled, parallel group study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Blinding device|
|Official Title:||Multicentre, Randomized, Double-blind, Parallel Group Phase III Study to Assess Efficacy and Safety of Dymista® Compared to Azep® and Flixonase® Nasal Sprays in the Treatment of Chinese Patients With Allergic Rhinitis/Rhinoconjunctivitis|
|Actual Study Start Date :||June 29, 2018|
|Actual Primary Completion Date :||September 24, 2019|
|Actual Study Completion Date :||September 24, 2019|
Experimental: Azelastine Hydrochl. + Fluticasone Prop.
Drug: Azelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUAT Nasal Spray, consists of a fixed-dose combination of azelastine hydrochloride and fluticasone propionate; 1 spray per nostril twice daily for 14 days, with 3 to 7 days of lead-in period. At a certain point during the study, patients will receive Placebo.
Drug: Azelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUAT
Dymista Nasal spray suspension
Other Name: Dymista
Active Comparator: Azelastine hydrochloride
Drug: Azelastine Hydrochloride 0.137 MG/ACTUAT Nasal Spray, 1 spray per nostril twice daily for 14 days, with 3 to 7 days of lead-in period. At a certain point during the study, patients will receive Placebo.
Drug: Azelastine Hydrochloride 0.137 MG/ACTUAT
AZEP Nasal spray solution
Other Name: AZEP
Active Comparator: Fluticasone propionate
Drug: Fluticasone Propionate 0.05 MG/ACTUAT Nasal Spray, 1 spray per nostril twice daily for 14 days, with 3 to 7 days of lead-in period. At a certain point during the study, patients will receive Placebo.
Drug: Fluticasone Propionate 0.05 MG/ACTUAT
Fluticasone propionate nasal spray suspension
Other Name: Flixonase
- Combined 12-hour rTNSS (AM + PM) [ Time Frame: 14 days ]Total nasal symptom score (TNSSS) is a sum of 4 individual nasal symptom scores: nasal itching, runny nose, congestion and sneezing. Each nasal symptom will be assessed according to a 4-ponit scale (0 = no, 1 = mild, 2 = moderate, 3 = severe symptom); thus, each TNSS will be in the range from 0 (no symptoms at all) to 12 (all 4 symptoms are severe) and the combined 12-hour reflective TNSS (morning + evening) will be in the range of 0 to 24 accordingly
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599791
|Study Director:||DucTung Nguyen, Dr.||Meda Pharma GmbH & Co. KG (A Mylan Company)|