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The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0.15% azelastine hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per nostril twice daily in patients with seasonal allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MP03-36 Nasal Spray | Active Comparator | azelastine hydrochloride 0.15% |
|
| MP03-36 and Placebo Nasal Spray | Active Comparator | azelastine hydrochloride 0.15% and Placebo |
|
| Azelastine 0.1%, Nasal Spray | Active Comparator | Azelastine 0.1%, Nasal Spray |
|
| Placebo Nasal Sapray | Placebo Comparator | 0mg, 2 sprays per nostril twice daily AM & PM) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| azelastine hydrochloride 0.15% Nasal Spray | Drug | 1644 mcg, 2 sprays per nostril twice daily AM & PM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 12-hour reflective total nasal symptoms score(TNSS) for the entire 14-day study period compared to placebo | 14 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in instantaneous total nasal symptoms score (TNSS) for the entire 14-day study period compared to placebo | 14 Days | |
| Change from baseline to Day 14 in Roland Quality of Life Questionnaire (RQLQ )compared to placebo | 14 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AABI Associates Medical Group | Fountain Valley | California | 92708 | United States | ||
| West Coast Clinical Trials |
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| azelastine hydrochloride 0.15% and Placebo | Drug | 822 mcg azelastine hydrochloride 0.15%, 2 sprays per nostril once daily (AM) and 0mg placebo spray 2 sprays per nostril once daily (PM) |
|
|
| Azelastine 0.1%, Nasal Spray | Drug | 1096 mcg, Azelastine 0.1%,2 sprays per nostril twice daily (AM & PM) |
|
|
| Change From Baseline on Direct Visual Nasal Exams | 14 Days |
| Long Beach |
| California |
| 90806 |
| United States |
| Allergy Research Foundation | Los Angeles | California | 90025 | United States |
| Southern California Research | Mission Viejo | California | 92691 | United States |
| Allergy Medical Group | Roseville | California | 95678 | United States |
| Allergy Associates Medical Group | San Diego | California | 92120 | United States |
| Allergy and Asthma Associates of CA | San Jose | California | 95117 | United States |
| The William Storms Allergy Clinic | Colorado Springs | Colorado | 80907 | United States |
| Colorado Allergy and Asthma Centers, PC | Denver | Colorado | 80230 | United States |
| Coastal Allergy and Asthma P.C. | Savannah | Georgia | 31406 | United States |
| Kansas City Allergy and Asthma | Overland Park | Kansas | 66210 | United States |
| Institute for Asthma and Allergy, P.C. | Wheaton | Maryland | 20902 | United States |
| Northeast Medical Research Associates, Inc. | North Dartmouth | Massachusetts | 02747 | United States |
| Clinical Research Institute | Minneapolis | Minnesota | 55402 | United States |
| The Asthma and Allergy Center, PC | Papillion | Nebraska | 68046 | United States |
| Atlantic Allergy, Asthma & Immunology | Ocean City | New Jersey | 07712 | United States |
| Princeton Center for Clinical Research | Skillman | New Jersey | 08558 | United States |
| Allergy and Asthma Institue of Rochester | Rochester | New York | 14618 | United States |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | United States |
| Clinical Research Center | Cincinnati | Ohio | 45231 | United States |
| Oklahoma Institute of Allergy and Asthma | Edmond | Oklahoma | 73003 | United States |
| Allergy and Asthma Consultants of NJ-PA, P.C | Collegeville | Pennsylvania | 19426 | United States |
| Valley Clinical Research Center | Easton | Pennsylvania | 18045 | United States |
| Allergy and Clinical Immunology Associates | Pittsburgh | Pennsylvania | 15241 | United States |
| Allergy Asthma Associates Research Dept. | Austin | Texas | 78731 | United States |
| AARA Research Center | Dallas | Texas | 75231 | United States |
| Research Across America | Dallas | Texas | 75234 | United States |
| Central Texas Health Research | New Braunfels | Texas | 78130 | United States |
| Sylvana Research Associates | San Antonio | Texas | 78229 | United States |
| Allergy and Asthma Center | Waco | Texas | 76712 | United States |
| 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 |
| D059085 | Nasal Sprays |
| ID | Term |
|---|---|
| D000336 | Aerosols |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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