Dymista in Chinese Adolescents (NCT07597473) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Dymista in Chinese Adolescents
China100 participantsStarted 2026-04-30
Plain-language 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).
Who can participate
Age range
12 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female Chinese participants aged 12 to 17 years (inclusive) at screening.
* informed consent/assent from participants and from parent(s) or legal guardian(s) in compliance with local requirements.
* Participants must have moderate-to-severe seasonal and/or perennial AR with or without ocular symptoms, defined as rhinitis with one or more of the following being present:
* Sleep disturbance
* Impairment of daily activities, leisure, and/or sport
* Impairment of learning or work
* Troublesome symptoms
* Moderate to severe seasonal and/or perennial AR with or without ocular symptoms in whom intranasal antihistamines or glucocorticoid monotherapy is not considered sufficient at the discretion of the Investigator and/or designee.
* Presence of Immunoglobulin E (IgE)-mediated hypersensitivity to one or more aeroallergens present in the current participant environment, confirmed by a positive response to an established standard diagnostic test at the site within the last year (before treatment start). Accepted diagnostic tests include:
* Skin prick tests
* Specific IgE tests Diagnosis of hypersensitivity will follow the current clinical practice at study sites.
* Acute allergic rhinitis symptoms at the day of inclusion evidenced by a 12-hour reflective TNSS ≥8 out of 12.
* General good health and free of any disease or concomitant treatment that may increase the risk associated with study participation or investigational product administra…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in AM+PM combined reflective Total Nasal Symptom Score (rTNSS).
Timeframe: From enrollment to end of treatment at 2 weeks.