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To evaluate the therapeutic equivalence of a test formulation of Azelastine hydrochloride and Fluticasone propionate Nasal Spray to the reference listed drug, Dymista™ Nasal Spray in the relief of the signs and symptoms of Seasonal Allergic Rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Test Product | Experimental | Azelastine hydrochloride and Fluticasone propionate Nasal Spray, 137/50 mcg |
|
| Reference Listed Drug | Active Comparator | Dymista™ (azelastine hydrochloride/fluticasone propionate) Nasal Spray, 137/50 mcg |
|
| Placebo | Placebo Comparator | Placebo Nasal Spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azelastine hydrochloride and Fluticasone propionate | Drug | 137/50 mcg Nasal Spray |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in average AM/PM reflective Total Nasal Symptom Score (rTNSS). | Days 1 to 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in average instantaneous Total Nasal Symptom Score (iTNSS). | Days 1 to 14 | |
| Change from baseline in average reflective Total Ocular Symptom Score (iTOSS). | Days 1 to 14 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Darin Brimhall, DO, FACP | Contact | (702) 435-3739 | 370 | dbrimhall@novumprs.som |
| Name | Affiliation | Role |
|---|---|---|
| Darin Brimhall, DO, FACP | Novum Pharmaceutical Research Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novum Pharmaceutical Research Services | Recruiting | Pittsburgh | Pennsylvania | 15206 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 6, 2020 | |
| Reset | Jan 13, 2020 | |
| Release | Oct 6, 2020 |
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| Dymista™ | Drug | 137/50 mcg Nasal Spray |
|
|
| Placebo | Other | Nasal spray with no pharmaceutically active content |
|
| Change from baseline in average instantaneous Total Ocular Symptom Score (iTOSS). |
| Days 1 to 14 |
| Onset of Action | 4 hours post dose |
| Reset | Oct 27, 2020 |
| Release | Aug 19, 2024 |
| Reset | Sep 10, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 6, 2020 | Jan 13, 2020 | |||
| Oct 6, 2020 | Oct 27, 2020 | |||
| Aug 19, 2024 | Sep 10, 2024 |
| 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 |
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| ID | Term |
|---|---|
| C020976 | azelastine |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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