Dymista in Chinese Adolescents

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.

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Allergic Rhinitis Due to Allergens
• Intervention / Treatment: Drug: Treatment with 137 µg azelastine hydrochloride and 50 μg of fluticasone propionate

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.

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
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Clinical Project Manager; Phone Number: 2208 +49 (0) 6172 888; Email: rainer.porrmann@viatris.com
• Study Contact Backup: Name: Clinical Project Manager-China; Phone Number: +86 18310551622; Email: yang.lv@viatris.com

Study Locations

• China
  • Beijing, China
    • Capital Center for Children's Health, Capital Medical University
  • Changsha, China
    • Hunan Provincial People's Hospital
  • Changsha, China
    • The Third XiangyaHospital of Central South University
  • Chengdu, China
    • Sichuan Provincial People's Hospital
  • Dalian, China
    • Dalian Municipal Central Hospital
  • Hangzhou, China
    • Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
  • Hangzhou, China
    • Children's Hospital of Zhejiang University School of Medicine
  • Nanchang, China
    • The Second Affiliated Hospital of Nanchang University
  • Shanghai, China
    • Eye & ENT Hospital of Fudan University
  • Taiyuan, China
    • The Second Affiliated Hospital of Shanxi Medical University
  • Tianjin, China
    • Tianjin Union Medical Center/Nankai University Affiliated Hospital
  • Wuhan, China
    • The Central Hospital of Wuhan
  • Wuhan, China
    • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Xi'an, China
    • The Second Affiliated Hospital of Xi'an JiaotongUniversity(XibeiHospital)
  • Zibo, China
    • Central Hospital of Zibo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 administration or could interfere with the interpretation of the study results as determined by the Investigator or the Sponsor's medical officer. When in doubt, the Investigator should confer with the Sponsor's medical monitor or designee to determine eligibility for the study.
• Negative pregnancy test in females with childbearing potential.
• Ability to understand and follow the instructions for using Dymista nasal spray according to the participant information leaflet.
• Willingness to complete and return the Patient Diary and comply with the study requirements.

Exclusion Criteria:

Safety concerns:

• Known allergic reaction from and/or intolerance to Dymista, azelastine hydrochloride, fluticasone propionate nasal sprays or any of the ingredients
• Pregnancy/planned pregnancy or breastfeeding during this study

Lack of suitability for the study:

• Participants or parent(s)/legal guardian(s) are not able to fulfil study requirements according to Investigator's opinion.
• Clinically significant nasal or sinus disease that may affect intranasal drug deposition, including but not limited to nasal mucosal erosion/ulceration or septum perforation (Grade 1b - 4), significant polyposis, marked septum deviation, active or recurrent sinusitis (>3 episodes/year), or nasal/sinus surgery within the past 12 months.
• The use of any investigational drug within 30 days or within 5 half-lives of the investigational drug (whichever is longer) prior to inclusion. No other investigational products are permitted for use during the conduct of this study.
• Respiratory tract infections within 7 days prior to inclusion.
• Asthma (with the exception of mild intermittent asthma). Participants with mild intermittent asthma who only require short-acting inhaled bronchodilators and who do not have nocturnal awakening as a result of asthma are eligible for enrolment.
• Current use or expected requirement of ritonavir or strong P4503A4 inhibitors including cobicistat-containing products.
• Specific immunotherapy within 6 months prior to Screening Visit. If the participant received immunotherapy a 6-month washout period is required following the last dose of immunotherapy.
• Use of the following medications or therapies within the time period specified below prior to Screening Visit:

Medication/Therapy Time Prior to Screening Visit

• Antihistamines: including oral, ocular, intranasal, prescribed and over the counter, biological active supplements, cold preparation, sleep aids containing such components (5 days)
• Oral and intranasal anticholinergic agents including ipratropium nasal spray (5 days)
• Inhaled, oral corticosteroids (30 days)
• Intranasal corticosteroids (14 days)
• Systemic steroids, includes oral, injected, intravenous [IV], (30 days)
• Ocular corticosteroids (7 days)
• Leukotriene inhibitors (14 days)
• Oral antibiotics for Respiratory tract infections (14 days)
• Cromolyn compounds, all mast cell stabilizers (14 days)
• Ephedrine or pseudoephedrine containing products (5 days)
• Decongestants including cold preparations (5 days)
• Traditional Chinese Medicines (TCM) for treatment of AR with known active ingredient, e.g. antihistamines, ephedrine or pseudoephedrine, (5 days)
• TCM for treatment of AR with unknown active ingredient (14 days)
• Tricyclic antidepressants (30 days)
• Monoamine oxidase inhibitors (14 days)
• Immunosuppressives/immunomodulators, e.g., anti-tumour necrosis factor (TNF) agents (30 days)
• IgE antagonist or other biologics (130 days)

Administrative reasons:

- Participants anticipating significant changes in their daily environmental exposure (e.g. travel more than 3 days).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment with intranasal spray of Dymista; The study drug will be delivered as an intranasal spray of Dymista (137 μg of azelastine hydrochloride and 50 μg of fluticasone propionate) in each nostril, BID, approximately 12 hours apart at AM and PM. The formulation is a white suspension which contains 120 sprays per bottle. The liquid medicine is sprayed out in a mist after actuator is pressed.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to end of treatment at 2 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	From enrollment to the end of treatment at 2 weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)	An adverse event (AE) is any untoward medical occurrence in a participants or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory or physical findings, symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. TEAE is defined as AE with onset date/time since the first dosing of study medication until 120 hours after the last dose of study medication.	From enrollment to 14 days after the last dose.

Collaborators and Investigators

• Sponsor: Viatris Inc.
• Collaborators: MEDA Pharma GmbH & Co. KG
• Investigators: Study Director: Duc Tung Nguyen, Dr., MEDA Pharma GmbH & Co. KG

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Allergic Rhinitis; Fluticasone propionate; Nasal spray; Azelastine hydrochloride
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Androstadienes; Androstenes; Androstanes; Fluticasone; Therapeutics; azelastine
• Other Study ID Numbers: AZFL-NS-4001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Company procedures to share IPD are under development. If procedures are established during the course of the study, the plan will be described.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No