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DYmista NAsal Spray in CHInese Patients

NCT03599791 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2022-02-22

No results posted yet for this study

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.

Conditions

  • Allergic Rhinitis

Interventions

DRUG

Azelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUAT

Dymista Nasal spray suspension

DRUG

Azelastine Hydrochloride 0.137 MG/ACTUAT

AZEP Nasal spray solution

DRUG

Fluticasone Propionate 0.05 MG/ACTUAT

Fluticasone propionate nasal spray suspension

Sponsors & Collaborators

  • MEDA Pharma GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • DucTung Nguyen, Dr. · Meda Pharma GmbH & Co. KG (A Mylan Company)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03599791 on ClinicalTrials.gov