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).
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. The Exclusion Criteria aim to ensure participant safety and study integrity. Individuals with known allergies to Dymista or its components, pregnant or breastfeeding females, or those unable to comply with study requirements are excluded. Additional exclusions include nasal conditions that interfere with drug delivery, recent nasal or sinus surgery, chronic sinusitis, recent use of investigational drugs or certain medications, respiratory infections, asthma (except mild intermittent), and recent immunotherapy. Individuals anticipating significant environmental changes are also excluded. Trial Treatment: Dymista nasal spray (137 μg of azelastine hydrochloride and 50 μg of fluticasone propionate, administered twice daily)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Treatment with 137 µg azelastine hydrochloride and 50 μg of fluticasone propionate twice daily in each nostril for 14 days
Capital Center for Children's Health, Capital Medical University
Beijing, China
RECRUITINGHunan Provincial People's Hospital
Changsha, China
RECRUITINGThe Third XiangyaHospital of Central South University
Changsha, China
RECRUITINGSichuan Provincial People's Hospital
Chengdu, China
RECRUITINGDalian Municipal Central Hospital
Dalian, China
RECRUITINGAffiliated Hangzhou First people's hospital, School of Medicine, Westlake University
Hangzhou, China
RECRUITINGChildren's Hospital of Zhejiang University School of Medicine
Hangzhou, China
RECRUITINGThe Second Affiliated Hospital of Nanchang University
Nanchang, China
RECRUITINGEye & Ent Hospital of Fudan University
Shanghai, China
RECRUITINGThe Second Affiliated Hospital of Shanxi Medical University
Taiyuan, China
RECRUITING...and 5 more locations
Change from baseline in AM+PM combined reflective Total Nasal Symptom Score (rTNSS).
Least Sqares (LS) mean change from baseline over 14 days (Day 2 to Day 14) in AM+PM combined rTNSS after treatment with Dymista nasal spray regardless of discontinuation for any reason or low compliance (treatment policy strategy). Explanation of rTNSS scale and score: The reflective Total Nasal Symptom Score (TNSS) evaluates nasal symptoms associated with AR. It includes four nasal symptoms: nasal itching, nasal congestion, runny nose (rhinorrhea) and sneezing. The symptom severity is scored on a four-point scale \[0-3\] for each symptom, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The severity of each symptom is assessed to arrive at the total TNSS score, which ranges from 0 to 12. Hence, the AM + PM combined TNSS ranges from 0 to 24.
Time frame: From enrollment to end of treatment at 2 weeks.
Changes from baseline in AM+PM combined reflective TOSS
The secondary objective is to evaluate efficacy in relief of further Allergic Rhinitis (AR) associated symptoms of Dymista in Chinese adolescents, having moderate to severe seasonal and/or perennial AR with or without ocular symptoms. Explanation of TOSS scale and scores: The reflective Total Ocular Symptom Score (TOSS) evaluates ocular symptoms associated with AR. It includes three symptoms: itchy eyes, watery eyes, and eye redness. The symptom severity is scored on a fourpoint scale \[0-3\] for each symptom, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The severity of each symptom is assessed to arrive at the total TOSS score, which ranges from 0 to 9. Hence, the AM + PM combined TOSS ranges from 0 to 18.
Time frame: From enrollment to the end of treatment at 2 weeks.
Changes from baseline in AM+PM combined reflective T7SS
The secondary objective is to evaluate efficacy in relief of further Allergic Rhinitis (AR) associated symptoms of Dymista in Chinese adolescents, having moderate to severe seasonal and/or perennial AR with or without ocular symptoms. Explanation of T7SS scale and scores: The reflective Total 7 Symptom Score (T7SS) evaluates the combined nasal and ocular symptoms (reflective Total Nasal Symptom Score + reflective Total Ocular Symptom Score) associated with AR. It includes all seven symptoms from rTNSS and rTOSS combined: nasal itching, nasal congestion, runny nose (rhinorrhea), sneezing, itchy eyes, watery eyes, and eye redness. The symptom severity is scored on a four-point scale \[0-3\] for each symptom, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The severity of each symptom is assessed to arrive at the total rT7SS score, which ranges from 0 to 21. Hence, the AM + PM combined T7SS ranges from 0 to 42.
Time frame: From enrollment to the end of treatment at 2 weeks.
Changes from baseline in individual nasal symptom scores (itchy nose, nasal congestion, runny nose, sneezing) and ocular symptom scores (itchy eyes, watery eyes, eye redness)
The secondary objective is to evaluate efficacy in relief of further Allergic Rhinitis (AR) associated symptoms of Dymista in Chinese adolescents, having moderate to severe seasonal and/or perennial AR with or without ocular symptoms. The symptom severity is scored on a four-point scale \[0-3\] for each symptom, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. Hence, each AM + PM combined individual symptom score ranges from 0 to 6.
Time frame: From enrollment to the end of treatment at 2 weeks.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.