Moderate to severe seasonal and/or perennial Allergic Rhinitis with or without ocular symptoms Seasonal Rhinitis: Term level: LLT, System organ class: Immune system disorders, Classification code: 10021428 Perennial Allergic Rhinitis: Term level: LLT, System organ class: Respiratory Thoracic and Mediastinal disorder, Classification code: 10038738
Conditions
Interventions
Trade Name: Dymista nasal spray
Pharmaceutical Form: Nasal spray
INN or Proposed INN: Azelastine hydrochloride
Other descriptive name: Azelastine hydrochloride
Concentration unit: mg/g milligram(s)/gr
Sponsors
Meda Pharma GmbH & Co. KG (A Viatris Company)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy of Dymista in relief of nasal symptoms in Chinese adolescents, having moderate to severe seasonal and/or perennial AR with or without ocular symptoms;Secondary Objective: To evaluate both efficacy in relief of further AR associated symptoms and safety of Dymista in Chinese adolescents, having moderate to severe seasonal and/or perennial AR with or without ocular symptoms;Primary end point(s): Change from baseline in AM+PM combined reflective Total Nasal Symptom Score (TNSS).;Timepoint(s) of evaluation of this end point: Least squares (LS) mean change from baseline over 14 days including all changes from baseline for all days (Day 2 to Day 14). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Changes from baseline in AM+PM combined reflective Total Ocular Symptom Score (TOSS) and Total 7 Symptom Score (T7SS) • 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);Timepoint(s) of evaluation of this end point: Same as for primary endpoint. | — |
Countries
China
Contacts
Public ContactEUClinicalTrials@Viatris
Meda Pharma GmbH & Co. KG (A Viatris Company)
Outcome results
None listed