Trial · NCT02230696
Comparative Safety and Efficacy of Two Steroid Treatments in the Relief of the Symptoms of Seasonal Allergic Rhinitis
NCT02230696, Phase 3, Completed, Padagis LLC; results first posted 2021-03-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparative Safety and Efficacy of Two Steroid Treatments in the Relief of the Symptoms of Seasonal Allergic Rhinitis. Trials, record NCT02230696. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02230696
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Safety and Efficacy of Two Steroid Treatments in the Relief of the Symptoms of Seasonal Allergic Rhinitis
- NCT number
- NCT02230696
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 951 participants, actual
- Lead sponsor
- Padagis LLC
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray, Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray, Placebo nasal spray
- First posted
- 2014-09-03
- Last updated
- 2021-10-22
- Results first posted
- 2021-03-15
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline for Mean Reflective Total Nasal Symptom Score (rTNSS) | Day 1 through Day 14 | The symptoms included in the reflective Total Nasal Symptom Score (rTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12. |
| Secondary | Mean Change From Baseline in the Mean Instantaneous Total Nasal Symptom Score (iTNSS) | Day 1 through Day 14 | The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12. |
| Secondary | Change From Baseline iTNSS Scores on Day 1 Post First Randomized Dose | Day 1, up to four hours post the first dose | This outcome measured the time to statistical significance of the reduction of signs/symptoms over a 4 hour period on Day 1 only by measuring the reduction in iTNSS scores. When the change from baseline was statistically significant, it was associated with a time to onset of the anti-histamine component of the formulation. Subjects will record iTNSS scores for 4 hours post first randomized dose. The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12. |
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 | Mean Change From Baseline for Mean Reflective Total Nasal Symptom Score (rTNSS) | Day 1 through Day 14 | Per protocol population | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in the Mean Instantaneous Total Nasal Symptom Score (iTNSS) | Day 1 through Day 14 | per-protocol population | score on a scale | MEAN |
| SECONDARY | Change From Baseline iTNSS Scores on Day 1 Post First Randomized Dose | Day 1, up to four hours post the first dose | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline for Mean Reflective Total Nasal Symptom Score (rTNSS) | Test Product | -2.95 | Standard Error .15 | score on a scale | |
| Mean Change From Baseline for Mean Reflective Total Nasal Symptom Score (rTNSS) | Reference Product | -3.13 | Standard Error .15 | score on a scale | |
| Mean Change From Baseline for Mean Reflective Total Nasal Symptom Score (rTNSS) | Placebo Nasal Spray | -1.98 | Standard Error .19 | score on a scale | |
| Mean Change From Baseline in the Mean Instantaneous Total Nasal Symptom Score (iTNSS) | Test Product | -2.81 | Standard Error 0.15 | score on a scale | |
| Mean Change From Baseline in the Mean Instantaneous Total Nasal Symptom Score (iTNSS) | Reference Product | -2.96 | Standard Error 0.15 | score on a scale | |
| Mean Change From Baseline in the Mean Instantaneous Total Nasal Symptom Score (iTNSS) | Placebo Nasal Spray | -1.88 | Standard Error .19 | score on a scale | |
| Change From Baseline iTNSS Scores on Day 1 Post First Randomized Dose | Test Product | -3.41 | Standard Error 0.15 | units on a scale | |
| Change From Baseline iTNSS Scores on Day 1 Post First Randomized Dose | Reference Product | -3.29 | Standard Error 0.15 | units on a scale | |
| Change From Baseline iTNSS Scores on Day 1 Post First Randomized Dose | Placebo Nasal Spray | -2.94 | Standard Error .20 | units on a scale |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Test Product | 381 | |
| Overall Study | STARTED | Reference Product | 376 | |
| Overall Study | STARTED | Placebo Product | 194 | |
| Overall Study | COMPLETED | Test Product | 366 | |
| Overall Study | COMPLETED | Reference Product | 365 | |
| Overall Study | COMPLETED | Placebo Product | 190 | |
| Overall Study | NOT COMPLETED | Test Product | 15 | |
| Overall Study | NOT COMPLETED | Reference Product | 11 | |
| Overall Study | NOT COMPLETED | Placebo Product | 4 |
Source ClinicalTrials.gov
Adverse events12
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 |
|---|---|---|---|---|---|---|
| serious | Fetal demise | Pregnancy, puerperium and perinatal conditions | Test Product | 0 | 381 | 0 |
| serious | Fetal demise | Pregnancy, puerperium and perinatal conditions | Reference Product | 1 | 376 | 1 |
| serious | Fetal demise | Pregnancy, puerperium and perinatal conditions | Placebo Product | 0 | 194 | 0 |
| serious | cervical disc herniation | Musculoskeletal and connective tissue disorders | Test Product | 1 | 381 | 1 |
| serious | cervical disc herniation | Musculoskeletal and connective tissue disorders | Reference Product | 0 | 376 | 0 |
| serious | cervical disc herniation | Musculoskeletal and connective tissue disorders | Placebo Product | 0 | 194 | 0 |
| serious | Infected cat bite | Infections and infestations | Test Product | 1 | 381 | 1 |
| serious | Infected cat bite | Infections and infestations | Reference Product | 0 | 376 | 0 |
| serious | Infected cat bite | Infections and infestations | Placebo Product | 0 | 194 | 0 |
| serious | suicidal ideations | Psychiatric disorders | Test Product | 1 | 381 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Test Product | 0 | 381 |
| Total, all-cause mortality | Reference Product | 0 | 376 |
| Total, all-cause mortality | Placebo Product | 0 | 194 |
| Total, other adverse events | Test Product | 0 | 381 |
| Total, other adverse events | Reference Product | 0 | 376 |
| Total, other adverse events | Placebo Product | 0 | 194 |
| Total, serious adverse events | Test Product | 3 | 381 |
| Total, serious adverse events | Reference Product | 1 | 376 |
| Total, serious adverse events | Placebo Product | 0 | 194 |
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 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/NCT02230696
GET https://conductscience.org/api/trials/v1/NCT02230696/registered