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Allergic Rhinitis Due to AllergensPhase 4NCT07597473

Dymista in Chinese Adolescents

A Phase 4 study testing Treatment with 137 µg azelastine hydrochloride and 50 μg of fluticasone propionate in people with Allergic Rhinitis Due to Allergens, run by Viatris Inc. at 14 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Allergic Rhinitis Due to Allergens
What is being tested?
Treatment with 137 µg azelastine hydrochloride and 50 μg of fluticasone propionate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
14 sitesChina
Study dates
8 May 2026to Oct 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

China14 sites

  • Capital Center for Children's Health, Capital Medical University

    Beijing

  • Hunan Provincial People's Hospital

    Changsha

  • Sichuan Provincial People's Hospital

    Chengdu

  • Dalian Municipal Central Hospital

    Dalian

  • Affiliated Hangzhou First people's hospital, School of Medicine, Westlake University

    Hangzhou

  • Children's Hospital of Zhejiang University School of Medicine

    Hangzhou

  • The Second Affiliated Hospital of Nanchang University

    Nanchang

  • Eye & Ent Hospital of Fudan University

    Shanghai

  • The Second Affiliated Hospital of Shanxi Medical University

    Taiyuan

  • Tianjin Union Medical Center/Nankai University Affiliated Hospital

    Tianjin

  • The Central Hospital of Wuhan

    Wuhan

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan

  • The Second Affiliated Hospital of Xi'an JiaotongUniversity(XibeiHospital)

    Xi'an

  • Central Hospital of Zibo

    Zibo

Other trials in China

About this study

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.

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.

Read more

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).
Read the 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)

Being tested
Treatment with 137 µg azelastine hydrochloride and 50 μg of fluticasone propionate
Keywords
Allergic Rhinitis, Azelastine hydrochloride, Fluticasone propionate, Nasal spray
Medical subject headings
Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment with 137 µg azelastine hydrochloride and 50 μg of fluticasone propionateDrug

    Treatment with 137 µg azelastine hydrochloride and 50 μg of fluticasone propionate twice daily in each nostril for 14 days

Study groups in NCT07597473
Study groupRoleWhat they receive
Treatment with intranasal spray of DymistaExperimentalThe 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.
Receives: Drug: Treatment with 137 µg azelastine hydrochloride and 50 μg of fluticasone propionate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to end of treatment at 2 weeks.

Secondary outcomes (3)

  1. 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.

    Measured: From enrollment to the end of treatment at 2 weeks.

  2. 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.

    Measured: From enrollment to the end of treatment at 2 weeks.

  3. 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.

    Measured: From enrollment to the end of treatment at 2 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2026
  2. Study start8 May 2026
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a single arm trial. 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.
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07597473
Sponsor's protocol ID
AZFL-NS-4001
Status last verified
Sep 2026
First submitted
27 Apr 2026
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Company procedures to share IPD are under development. If procedures are established during the course of the study, the plan will be described.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Treatment with 137 µg azelastine hydrochloride and 50 μg of fluticasone propionate in people with Allergic Rhinitis Due to Allergens, run by Viatris Inc. at 14 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in AM+PM combined reflective Total Nasal Symptom Score (rTNSS). (time frame: From enrollment to end of treatment at 2 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07597473.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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