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Dymista in Chinese Adolescents
Sponsor: Viatris Inc.
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
Conditions
Interventions
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