Trial · NCT07597473
Dymista in Chinese Adolescents
NCT07597473, Phase 4, Completed, Viatris Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dymista in Chinese Adolescents. Trials, record NCT07597473. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07597473
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dymista in Chinese Adolescents
- NCT number
- NCT07597473
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 100 participants, actual
- Lead sponsor
- Viatris Inc.
- Conditions
- Allergic Rhinitis Due to Allergens
- Interventions
- Treatment with 137 µg azelastine hydrochloride and 50 μg of fluticasone propionate
- First posted
- 2026-05-19
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in AM+PM combined reflective Total Nasal Symptom Score (rTNSS). | From enrollment to end of treatment at 2 weeks. | 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. |
| Secondary | Changes from baseline in AM+PM combined reflective TOSS | From enrollment to the end of treatment at 2 weeks. | 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. |
| Secondary | Changes from baseline in AM+PM combined reflective T7SS | From enrollment to the end of treatment at 2 weeks. | 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. |
| Secondary | 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. | 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. |
| Other | Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | From enrollment to 14 days after the last dose. | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07597473
GET https://conductscience.org/api/trials/v1/NCT07597473/registered