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Dymista in Chinese Adolescents

NCT07597473 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-19

No results posted yet for this study

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).

Conditions

  • Allergic Rhinitis Due to Allergens

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

Sponsors & Collaborators

  • MEDA Pharma GmbH & Co. KG

    collaborator INDUSTRY

  • Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Duc Tung Nguyen, Dr. · MEDA Pharma GmbH & Co. KG

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-03-31
Completion
2027-03-31

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 NCT07597473 on ClinicalTrials.gov