Trial · NCT05590598
Efficacy and Safety of Azelastine +Mometasone , Nasal Spray, 140 mcg + 50 mcg, (Sandoz d.d., Slovenia) and Momat Rino Advance, Nasal Spray, 140 mcg + 50 mcg, (Glenmark, India) Administered as a Monotherapy to Patients With Seasonal Allergic Rhinitis.
NCT05590598, Phase 3, Completed, Sandoz
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Azelastine +Mometasone , Nasal Spray, 140 mcg + 50 mcg, (Sandoz d.d., Slovenia) and Momat Rino Advance, Nasal Spray, 140 mcg + 50 mcg, (Glenmark, India) Administered as a Monotherapy to Patients With Seasonal Allergic Rhinitis. Trials, record NCT05590598. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05590598
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Efficacy and Safety of Azelastine +Mometasone , Nasal Spray, 140 mcg + 50 mcg, (Sandoz d.d., Slovenia) and Momat Rino Advance, Nasal Spray, 140 mcg + 50 mcg, (Glenmark, India) Administered as a Monotherapy to Patients With Seasonal Allergic Rhinitis.
- NCT number
- NCT05590598
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 472 participants, actual
- Lead sponsor
- Sandoz
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Azelastine + Mometazone, nasal spray, Momat Rhino Advance
- First posted
- 2022-10-21
- Last updated
- 2023-08-04
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean total score change as per scale r-TNSS (AM/PM) with initial total score | Day 1, 7 and 15 post treatment | r-TNSS (reflective Total Nasal Symptom Score) consists of 4 symptom scores (Nasal congestion, Runny nose, Itchy nose, Sneezing), each of which can be scored on a 4-point scale (0-3). Higher scores mean a more severe symptom. By its nature, the total index r-TNSS is a rank indicator, it is an integer from the range from 0 to 12 points. As a working indicator, the average between the morning and evening values is used. As a measure of the effect of the drug, the change in the index relative to the initial value is used. Baseline is defined as the average r-TNSS score over three days of the Run-in period (2 morning (AM) and 3 evening (PM)) plus morning measurements of study day 1 (assessment in the morning prior to first administration). |
| Secondary | Mean total score change as per scale i-TNSS (AM/PM) with initial total score | Day 1, 7 and 15 post treatment | i-TNSS (instantaneous Total Nasal Symptom Score) - TNSS scale consists of 4 symptom scores for assessment of SAR nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing) that reflects intensity of nasal symptoms immediately at the moment of their assessment and filling of questionnaire. Each score can be scored on a 4-point scale (0-3). Higher scores mean a more severe symptom. Total score as per scale i-TNSS = (Average morning score (AM) as per scale i-TNSS + Average evening score (PM) as per scale i-TNSS) / 2 Initial total score as per scale i-TNSS = Is an average total score as per scale i-TNSS for three days of the Run-in period (2 morning (AM) and 3 evening (PM)) plus morning measurements of study day 1 (assessment in the morning prior to first administration). |
| Secondary | Mean change in total score as per scales i-TNSS and r-TNSS with initial total score | Day 1, 7 and 15 post treatment | Mean change in total score as per scales i-TNSS and r-TNSS with initial total score was reported. |
| Secondary | Change in Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)) | Day 1, 7 and 15 post treatment | The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults with either seasonal or perennial rhinoconjunctivitis of either allergic or non-allergic origin. RQLQ is a 7-point scale (0 = not impaired at all - 6 = severely impaired). |
| Secondary | Number of Adverse events | throughout the study, approximately 18 days | Number of Adverse events were reported. |
| Secondary | Proportion of patients with at least one adverse event | throughout the study, approximately 18 days | Proportion of patients with at least one adverse event were reported. |
| Secondary | Proportion of patients who discontinued treatment because of an adverse event | throughout the study, approximately 18 days | Proportion of patients who discontinued treatment because of an adverse event were reported. |
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/NCT05590598
GET https://conductscience.org/api/trials/v1/NCT05590598/registered