Trial · NCT01915823
Safety and Efficacy Trial of Dymista Nasal Spray in Children Ages 4 to 11 With Seasonal Allergic Rhinitis (SAR)
NCT01915823, Phase 3, Completed, Meda Pharmaceuticals; results first posted 2015-06-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Trial of Dymista Nasal Spray in Children Ages 4 to 11 With Seasonal Allergic Rhinitis (SAR). Trials, record NCT01915823. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01915823
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Trial of Dymista Nasal Spray in Children Ages 4 to 11 With Seasonal Allergic Rhinitis (SAR)
- NCT number
- NCT01915823
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 348 participants, actual
- Lead sponsor
- Meda Pharmaceuticals
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- azelastine hydrochloride and fluticasone propionate, Dymista vehicle
- First posted
- 2013-08-05
- Last updated
- 2015-06-29
- Results first posted
- 2015-06-29
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Efficacy | 15 days of treatment | change from baseline in AM+PM rTNSS (reflective total nasal symptoms score): ITT( intent to treat population)change from baseline in 12-hour reflective total nasal symptom score (rTNSS) consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary for the entire 14 day study period.The measurement scale is 0 to 24 so that the higher the number the worse the symptom.A reduction in symptom severity score is indicated by a negative value.A greater negative value suggests improvement. |
| Secondary | Safety | entire length of study (day 1 to day 22) | * Subject-reported adverse experiences (incidence, type, and severity of adverse events) * Nasal Examinations * Vital signs assessments |
| Other | Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) | day 1 to day 15 of treatment | Change from baseline to Visit 4 in the ITT ( intent to treat) Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) in subjects equal to or greater than 6 years old and less than12 years old compared to placebo.Scored on a 0 to 7 scale with 0 being not troubled at all and 7 being extremely troublesome. The higher the difference the better the result. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Efficacy | 15 days of treatment | units on a scale | MEAN | |
| SECONDARY | Safety | entire length of study (day 1 to day 22) | occurance | NUMBER | |
| OTHER_PRE_SPECIFIED | Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) | day 1 to day 15 of treatment | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Primary Efficacy | Dymista | -3.83 | Standard Deviation 5.154 | units on a scale | |
| Primary Efficacy | Dymista Vehicle | -2.77 | Standard Deviation 4.731 | units on a scale | |
| Safety | Dymista | 28 | occurance | ||
| Safety | Dymista Vehicle | 23 | occurance | ||
| Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) | Dymista | -.91 | Standard Deviation 1.22 | units on a scale | |
| Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) | Dymista Vehicle | -.66 | Standard Deviation 1.22 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dymista | 173 | |
| Overall Study | STARTED | Dymista Vehicle | 175 | |
| Overall Study | COMPLETED | Dymista | 171 | |
| Overall Study | COMPLETED | Dymista Vehicle | 173 | |
| Overall Study | NOT COMPLETED | Dymista | 2 | |
| Overall Study | NOT COMPLETED | Dymista Vehicle | 2 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | dysgusia | Nervous system disorders | Dymista | 7 | 173 | |
| other | dysgusia | Nervous system disorders | Dymista Vehicle | 0 | 175 | |
| other | epistaxis | Respiratory, thoracic and mediastinal disorders | Dymista | 6 | 173 | |
| other | epistaxis | Respiratory, thoracic and mediastinal disorders | Dymista Vehicle | 6 | 175 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dymista | ||
| Total, all-cause mortality | Dymista Vehicle | ||
| Total, other adverse events | Dymista | 13 | 173 |
| Total, other adverse events | Dymista Vehicle | 6 | 175 |
| Total, serious adverse events | Dymista | 0 | 173 |
| Total, serious adverse events | Dymista Vehicle | 0 | 175 |
Source ClinicalTrials.gov
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dymista vs Dymista Vehicle: serious adverse events |
Source Trial comparisons
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/NCT01915823
GET https://conductscience.org/api/trials/v1/NCT01915823/registered