Trial · NCT06126952
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in TNSS at each post-dose assessment time point (0 to 4 hours after a single dose). | 0 to 4 hours post application | Onset of action of azelastine hydrochloride 0.15% nasal spray (Azelastine 0.15%) in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Unit (EEU), measured by a difference from placebo in the change from baseline in patient -assessed instantaneous Total nasal symptom score (TNSS). FDA guideline defines onset of action as the first time point after initiation of treatment when the product demonstrated a greater change from baseline compared to placebo which proved durable. The TNSS is comprised of 4 symptoms from the nose, each scored on a scale of 0 to 3 (0 = none and 3 = severe). The sum of the TNSS contributes to a score ranging from 0 - 12. |
| Secondary | Changes from baseline in TNSS at each post-dose assessment time point (0 to 4 hours after a single dose) at Visits 3, 6, and 9. | 0 to 4 hours post application | Onset of action, measured by the differences of both active treatments versus placebo in the change from baseline in patient-assessed instantaneous total symptom scores following treatment. FDA guideline defines onset of action as the first time point after initiation of treatment when the product demonstrated a greater change from baseline compared to placebo which proved durable. The TNSS is comprised of 4 symptoms from the nose, each scored on a scale of 0 to 3 (0 = none and 3 = severe). The sum of the TNSS contributes to a score ranging from 0 - 12. |
| Secondary | Changes from baseline in TOSS at each post-dose assessment time point (0 to 4 hours after a single dose) at Visits 3, 6, and 9. | 0 to 4 hours post application | Onset of action, measured by the differences of both active treatments versus placebo in the change from baseline in patient-assessed instantaneous total symptom scores following treatment. FDA guideline defines onset of action as the first time point after initiation of treatment when the product demonstrated a greater change from baseline compared to placebo which proved durable. The TOSS is comprised of 3 symptoms from the eyes, each scored on a scale of 0 to 3 (0 = none and 3 = severe). The sum of the TOSS contributes to a score ranging from 0 - 9. |
| Secondary | Changes from baseline in T7SS at each post-dose assessment time point (0 to 4 hours after a single dose) at Visits 3, 6, and 9. | 0 to 4 hours post application | Onset of action, measured by the differences of both active treatments versus placebo in the change from baseline in patient-assessed instantaneous total symptom scores following treatment. FDA guideline defines onset of action as the first time point after initiation of treatment when the product demonstrated a greater change from baseline compared to placebo which proved durable. The total 7 symptoms score (T7SS) will be the combination of the TNSS and TOSS, for a combined maximum score of 21. |
| Secondary | Change from baseline in individual symptom scores at each post-dose assessment time point (0 to 4 hours after a single dose) at Visits 3, 6, and 9. | 0 to 4 hours post application | Onset of action, measured by change from baseline in individual symptom scores at each post-dose assessment time point (0 to 4 hours after a single dose) at Visits 3, 6, and 9. Each individual symptom is scored on a scale of 0 to 3 (0 = none and 3 = severe). Secondary endpoint include pairwise treatment comparisons of both active treatments versus placebo. |
| Secondary | Changes from baseline in TNSS for all assessment time-points together. | 0 to 4 hours post application | Overall Efficacy, measured by changes from baseline in TNSS for all assessments during 0-4 hours and for visits 3, 6 and 9 together. The TNSS is comprised of 4 symptoms from the nose, each scored on a scale of 0 to 3 (0 = none and 3 = severe). The sum of the TNSS contributes to a score ranging from 0 - 12. |
| Secondary | Changes from baseline in TOSS for all assessment time-points together. | 0 to 4 hours post application | Overall Efficacy, measured by changes from baseline in TOSS for all assessments during 0-4 hours and for visits 3, 6 and 9 together. The TOSS is comprised of 3 symptoms from the eyes, each scored on a scale of 0 to 3 (0 = none and 3 = severe). The sum of the TOSS contributes to a score ranging from 0 - 9. |
| Secondary | Changes from baseline in T7SS for all assessment time-points together. | 0 to 4 hours post application | Overall Efficacy, measured by changes from baseline in T7SS for all assessments during 0-4 hours and for visits 3, 6 and 9 together. The total 7 symptoms score (T7SS) will be the combination of the TNSS and TOSS, for a combined maximum score of 21. |
| Secondary | Change from baseline in individual symptom scores for all assessment time-points together. | 0 to 4 hours post application | Overall Efficacy, measured by change from baseline in individual symptom scores for all assessments during 0-4 hours and for visits 3, 6 and 9 together. Each individual symptom is scored on a scale of 0 to 3 (0 = none and 3 = severe). |
| Secondary | Changes from baseline in TNSS for all assessment time-points together. | 0-4 hours after 3-day treatment | Overall Efficacy, measured by changes from baseline in TNSS for all assessments during 0-4 hours and for visits 4, 7 and 10 together after 3-day treatment. The TNSS is comprised of 4 symptoms from the nose, each scored on a scale of 0 to 3 (0 = none and 3 = severe). The sum of the TNSS contributes to a score ranging from 0 - 12. |
| Secondary | Changes from baseline in TOSS for all assessment time-points together. | 0-4 hours after 3-day treatment | Overall Efficacy, measured by changes from baseline in TOSS for all assessments during 0-4 hours and for visits 4, 7 and 10 together after 3-day treatment. The TOSS is comprised of 3 symptoms from the eyes, each scored on a scale of 0 to 3 (0 = none and 3 = severe). The sum of the TOSS contributes to a score ranging from 0 - 9. |
| Secondary | Changes from baseline in T7SS for all assessment time-points together. | 0-4 hours after 3-day treatment | Overall Efficacy, measured by changes from baseline in T7SS for all assessments during 0-4 hours and for visits 4, 7 and 10 together after 3-day treatment. The total 7 symptoms score (T7SS) will be the combination of the TNSS and TOSS, for a combined maximum score of 21. |
| Secondary | Change from baseline in individual symptom scores for all assessment time-points together. | 0-4 hours after 3-day treatment | Overall Efficacy, measured by change from baseline in individual symptom scores for all assessments during 0-4 hours and for visits 4, 7 and 10 together after 3-day treatment. Each individual symptom is scored on a scale of 0 to 3 (0 = none and 3 = severe). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06126952/registered