Dymista in Chinese Adolescents
brief 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).
detailed description
Trial Design and Rationale for Trial Design:
This is a multicenter, phase 4, single arm clinical trial to evaluate the efficacy and safety of Dymista nasal spray (137 μg of azelastine hydrochloride and 50 μg of fluticasone propionate) in the treatment of AR in Chinese adolescents with or without ocular symptoms. Because Dymista has already been approved, this trial design is selected to gather additional data on efficacy and safety of Dymista in Chinese adolescents in a close to real-world setting but under clinical oversight.
Number of Participants: Approximately 100 participants will be enrolled into the study.
Number of Arms: Single arm
Duration: Total duration of trial participation for each participant will vary from 29 to 60 days (depending on extended periods of screening, treatment, and follow-up).
This trial starts with approximately -7 to 1 day of screening period, i.e., Visit 2 (start of treatment) can eventually be on the same day of Visit 1 or up to 7 days later. Treatment period will be for 2 weeks (14+5 days) during which participants will administer Dymista nasal spray (137 μg of azelastine hydrochloride and 50 μg of fluticasone propionate) in each nostril, twice daily (BID) and then return to the study site at Visit 3 for end of study examination on Day 15 (+5). Subsequently, participants will be followed up for any AEs for 2 weeks (14+5 days) after the last dose via phone. Once an AE is detected and ongoing, it should be followed up at least two weeks later (i.e., 28 (+5) days after last dose) until its resolution or until it is judged by the principal investigator to be stable or permanent.
Blinding: Not Applicable (No blinding).
Main Selection Criteria - Inclusion and Exclusion criteria of Trial Population:
The Inclusion Criteria for the study focus on enrolling Chinese participants aged 12-17 years who have moderate-to-severe seasonal and/or perennial AR, with or without ocular symptoms. Participants must show signs of Immunoglobulin E (IgE)-mediated hypersensitivity confirmed by diagnostic tests, have acute allergic rhinitis symptoms at inclusion, and be in general good health. They must also be able to use Dymista nasal spray correctly, agree to complete study requirements such as the patient diary, and provide informed consent/assent along with their legal guardians.
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.