Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| C2D03217 | Other Identifier | Cliantha Research, Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is to assess the Onset of Action and Efficacy of azelastine hydrochloride 0.15% in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Unit (EEU) followed by a single dose and a 3-day treatment at home.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A (Azelair)+Treatment B (Placebo)+Treatment C (Ryaltris), min. 14 days wash-out period | Experimental | Cross-over design |
|
| Treatment B (Placebo)+Treatment C (Ryaltris)+Treatment A (Azelair), min. 14 days of wash-out period | Experimental | Cross-over design |
|
| Treatment C (Ryaltris)+Treatment A (Azelair)+Treatment B (Placebo), min. 14 days of wash-out period | Experimental | Cross-over design |
|
| Treatment A (Azelair)+Treatment C (Ryaltris)+Treatment B (Placebo), min. 14 days of wash-out period | Experimental | Cross-over design |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair) | Drug | 2 sprays per nostril of Azelastine 0.15% twice daily. Total dose of active drug: 1644 mcg azelastine hydrochloride per day |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in TNSS at each post-dose assessment time point (0 to 4 hours after a single dose). | 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. | 0 to 4 hours post application |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
Not provided
Main Inclusion Criteria:
Main Exclusion Criteria:
Safety Concerns:
Lack of suitability for the study:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Patricia Couroux, Dr. | Cliantha Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliantha Research | Mississauga | Ontario | L4W1A4 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will be a single-center, randomized, placebo-controlled, double-blind trial with three periods and six sequences (cross-over design).
Not provided
Not provided
Not provided
| Treatment B (Placebo)+Treatment A (Azelair)+Treatment C (Ryaltris), min.14 days of wash-out period | Experimental | Cross-over design |
|
| Treatment C (Ryaltris)+Treatment B (Placebo)+Treatment A (Azelair), min. 14 days of wash-out period | Experimental | Cross-over design |
|
| Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray | Drug | 2 sprays per nostril of Placebo twice daily. |
|
| Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray | Drug | 2 sprays per nostril of Ryaltris twice daily. Total dose of active drug: 200 mcg mometasone furoate and 4800 mcg olopatadine per day |
|
| 0 to 4 hours post application |
| 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. | 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. | 0 to 4 hours post application |
| 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. | 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. | 0 to 4 hours post application |
| 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. | 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. | 0 to 4 hours post application |
| Changes from baseline in TNSS for all assessment time-points together. | 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. | 0 to 4 hours post application |
| Changes from baseline in TOSS for all assessment time-points together. | 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. | 0 to 4 hours post application |
| Changes from baseline in T7SS for all assessment time-points together. | 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. | 0 to 4 hours post application |
| Change from baseline in individual symptom scores for all assessment time-points together. | 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). | 0 to 4 hours post application |
| Changes from baseline in TNSS for all assessment time-points together. | 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. | 0-4 hours after 3-day treatment |
| Changes from baseline in TOSS for all assessment time-points together. | 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. | 0-4 hours after 3-day treatment |
| Changes from baseline in T7SS for all assessment time-points together. | 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. | 0-4 hours after 3-day treatment |
| Change from baseline in individual symptom scores for all assessment time-points together. | 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). | 0-4 hours after 3-day treatment |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059085 | Nasal Sprays |
| C020976 | azelastine |
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D000336 | Aerosols |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided