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NOT YET RECRUITING
NCT07597473
PHASE4

Dymista in Chinese Adolescents

Sponsor: Viatris Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if the investigational drug product ("study drug"), Dymista (azelastine hydrochloride and fluticasone propionate) nasal spray is safe and effective in the treatment of allergic rhinitis in Chinese adolescents with or without ocular symptoms. It is expected that approximately, 100 participants will be enrolled in this study. The study will be performed in approximately 15 clinical study centers in China. Study participants will be asked to complete up to 3 study visits at the study site and a follow-up by telephone. Treatment Assignment: All participants will receive a bottle of Dymista nasal spray and should administer it at a dose of twice daily (one spray per nostril), once in the morning and once in the afternoon, the doses will be approximately 12 hours apart. The liquid medicine is sprayed out in a mist after actuator is pressed. You will administer the trial intervention for 14 (+5) days. Regular study schedule: * Screening visit (Visit 1, Day -7 to 1) * Baseline visit (Visit 2, Day 1) * Visits 3 (End of Trial (EOS), Day 15 (+5)) * Follow-up (Telephone Call, within 14 (+5) days after the last administration of Dymista) The participation may last approximately 29 days to 60 days (depending on extended periods of screening, treatment, and follow-up).

Official title: Multicenter, Phase 4, Single-Arm Clinical Trial to Evaluate Efficacy and Safety of Dymista (Azelastine Hydrochloride and Fluticasone Propionate) Nasal Spray in the Treatment of Allergic Rhinitis in Chinese Adolescents With or Without Ocular Symptoms.

Key Details

Gender

All

Age Range

12 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-04-30

Completion Date

2027-03

Last Updated

2026-05-19

Healthy Volunteers

No

Interventions

DRUG

Treatment with 137 µg azelastine hydrochloride and 50 μg of fluticasone propionate

Treatment with 137 µg azelastine hydrochloride and 50 μg of fluticasone propionate twice daily in each nostril for 14 days

Locations (15)

Capital Center for Children's Health, Capital Medical University

Beijing, China

Hunan Provincial People's Hospital

Changsha, China

The Third XiangyaHospital of Central South University

Changsha, China

Sichuan Provincial People's Hospital

Chengdu, China

Dalian Municipal Central Hospital

Dalian, China

Affiliated Hangzhou First people's hospital, School of Medicine, Westlake University

Hangzhou, China

Children's Hospital of Zhejiang University School of Medicine

Hangzhou, China

The Second Affiliated Hospital of Nanchang University

Nanchang, China

Eye & Ent Hospital of Fudan University

Shanghai, China

The Second Affiliated Hospital of Shanxi Medical University

Taiyuan, China

Tianjin Union Medical Center/Nankai University Affiliated Hospital

Tianjin, China

The Central Hospital of Wuhan

Wuhan, China

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

The Second Affiliated Hospital of Xi'an JiaotongUniversity(XibeiHospital)

Xi'an, China

Central Hospital of Zibo

Zibo, China