Dymista in Chinese Adolescents

NCT07597473 | Not Yet Recruiting Phase 4

• 1 other identifier: AZFL-NS-4001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 15

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).

Conditions

Allergic Rhinitis Due to Allergens

Keywords

Allergic Rhinitis; Azelastine hydrochloride; Fluticasone propionate; Nasal spray

Outcome Measures

Primary Outcomes (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.

  From enrollment to end of treatment at 2 weeks.

Secondary Outcomes (3)

• Changes from baseline in AM+PM combined reflective TOSS

  From enrollment to the end of treatment at 2 weeks.

• Changes from baseline in AM+PM combined reflective T7SS

  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)

  From enrollment to the end of treatment at 2 weeks.

Other Outcomes (1)

• Number of Subjects With Treatment-emergent Adverse Events (TEAEs)

  From enrollment to 14 days after the last dose.

Study Arms (1)

Treatment with intranasal spray of Dymista

EXPERIMENTAL

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

Interventions

Treatment with 137 µg azelastine hydrochloride and 50 μg of fluticasone propionate DRUG

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

Treatment with intranasal spray of Dymista

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Viatris Inc.: lead
• MEDA Pharma GmbH & Co. KG: collaborator

Study Sites (15)

Capital Center for Children's Health, Capital Medical University

Beijing, China

Location

Hunan Provincial People's Hospital

Changsha, China

Location

The Third XiangyaHospital of Central South University

Changsha, China

Location

Sichuan Provincial People's Hospital

Chengdu, China

Location

Dalian Municipal Central Hospital

Dalian, China

Location

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

Hangzhou, China

Location

Children's Hospital of Zhejiang University School of Medicine

Hangzhou, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, China

Location

Eye & Ent Hospital of Fudan University

Shanghai, China

Location

The Second Affiliated Hospital of Shanxi Medical University

Taiyuan, China

Location

Tianjin Union Medical Center/Nankai University Affiliated Hospital

Tianjin, China

Location

The Central Hospital of Wuhan

Wuhan, China

Location

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

Wuhan, China

Location

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

Xi'an, China

Location

Central Hospital of Zibo

Zibo, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Therapeutics; azelastine; Fluticasone

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Duc Tung Nguyen, Dr.

  MEDA Pharma GmbH & Co. KG

  STUDY DIRECTOR

Central Study Contacts

Clinical Project Manager

CONTACT

+49 (0) 6172 888; rainer.porrmann@viatris.com

Clinical Project Manager-China

CONTACT

+86 18310551622; yang.lv@viatris.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 19, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)