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This is a 3 month safety study of Dymista Nasal spray in children aged 4 to 11 years with allergic rhinitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dymista nasal spray | Active Comparator | azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months |
|
| fluticasone propionate nasal spray | Active Comparator | fluticasone propionate nasal spray 50mcg per spray per nostril twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dymista Nasal Spray | Drug |
| ||
| Fluticasone propionate nasal spray |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Report | reports of treatment emergent adverse events | 3 months of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Ruiz, M.D. | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center of Alabama,LLC | Birmingham | Alabama | 35209 | United States | ||
| Little Rock Allergy and Asthma Clinical research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29490769 | Derived | Berger W, Sher E, Gawchik S, Fineman S. Safety of a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate in children: A randomized clinical trial. Allergy Asthma Proc. 2018 Mar 1;39(2):110-116. doi: 10.2500/aap.2018.39.4116. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dymista Nasal Spray | azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months Dymista Nasal Spray |
| FG001 | Fluticasone Propionate Nasal Spray |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| Little Rock |
| Alaska |
| 72205 |
| United States |
| West Coast Clinical Trials | Costa Mesa | California | 92626 | United States |
| Allergy & Asthma Care Center of So. Cal | Long Beach | California | 90808 | United States |
| Southern California Research | Mission Viejo | California | 92691 | United States |
| Allergy Associates Medical Group Inc | San Diego | California | 92120 | United States |
| Allergy & Asthma Associates of Santa Clara Valley Research Cntr | San Jose | California | 95117 | United States |
| Storms Clinical Research Institute | Colorado Springs | Colorado | 80907 | United States |
| Colorado Allergy and Asthma Centers, PC | Denver | Colorado | 80230 | United States |
| Asthma and Allergy Associates, PC | Pueblo | Colorado | 81001 | United States |
| Allergy and Asthma Care of Florida | Ocala | Florida | 34471 | United States |
| Atlanta Allergy and Asthma Clinic | Stockbridge | Georgia | 30281 | United States |
| Idaho Allergy | Eagle | Idaho | 83616 | United States |
| Sneeze, Wheeze and Itch Associates | Normal | Illinois | 61761 | United States |
| Clinical Research Institute of Indiana | Indianapolis | Indiana | 46208 | United States |
| Family Allergy and Asthma Reserach | Louisville | Kentucky | 40215 | United States |
| Respiratory Medicine Research Institute of Michigan | Ypsilanti | Michigan | 48197 | United States |
| Clinical Reseacrh Institute | Minneapolis | Minnesota | 55402 | United States |
| The Clinical Research Center | St Louis | Missouri | 63141 | United States |
| Clinical Research of the Ozarks,Inc | Warrensburg | Missouri | 64093 | United States |
| Midwest Allergy and Asthma Clinic | Omaha | Nebraska | 68130 | United States |
| The Asthma and Allergy Center, PC | Papillion | Nebraska | 68046 | United States |
| Atlantic Research Center | Ocean City | New Jersey | 07712 | United States |
| Asthma, Sinus & Allergy Centers, LLC | Warren Township | New Jersey | 07059 | United States |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | United States |
| Bernstein Clinical Research Center | Cincinnati | Ohio | 45231 | United States |
| Allergy, Asthma & Clinical Research Center | Oklahoma City | Oklahoma | 73120 | United States |
| Oklahoma Institute of Allergy and Asthma | Oklahoma City | Oklahoma | 73131 | United States |
| Baker Allergy Asthma & Dermatology Ctr LLC | Lake Oswego | Oregon | 97035 | United States |
| Allergy and Asthma Specialist PC | Blue Bell | Pennsylvania | 19422 | United States |
| National Allergy, Asthna & Urticaria Centers of Charleston Pa | Charleston | Pennsylvania | 29406 | United States |
| Allergy and Clinical Immunology Associates | Pittsburgh | Pennsylvania | 15241 | United States |
| Asthma and Allergy Research Associate | Upland | Pennsylvania | 19013 | United States |
| ADAC Research, PA | Greenville | South Carolina | 29607 | United States |
| AARA Research Center | Dallas | Texas | 75231 | United States |
| Texas Allergy Research Center | Dallas | Texas | 75246 | United States |
| Central Texas Health Research | New Braunfels | Texas | 78130 | United States |
| Paul H Ratner,MD | San Antonio | Texas | 78229 | United States |
| Live Oak Allergy and Asthma Clinic | San Antonio | Texas | 78233 | United States |
| Allergy Asthma Research Institute | Waco | Texas | 76712 | United States |
| Pediatric Allergy,Asthma and Immunology/Allergy& Asthma care of Waco | Waco | Texas | 76712 | United States |
fluticasone propionate nasal spray 50mcg per spray per nostril twice a day
Fluticasone propionate nasal spray
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dymista Nasal Spray | azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months Dymista Nasal Spray |
| BG001 | Fluticasone Propionate Nasal Spray | fluticasone propionate nasal spray 50mcg per spray per nostril twice a day Fluticasone propionate nasal spray |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Events Report | reports of treatment emergent adverse events | Posted | Number | event | 3 months of treatment |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dymista Nasal Spray | azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months Dymista Nasal Spray | 1 | 304 | 114 | 304 | ||
| EG001 | Fluticasone Propionate Nasal Spray | fluticasone propionate nasal spray 50mcg per spray per nostril twice a day Fluticasone propionate nasal spray | 0 | 101 | 25 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gastroenteritis elevated LFT | Gastrointestinal disorders | Systematic Assessment | one case of gastroenteritis ,patient with history of Chron's disease,deemed highly unlikely related to treatment, fully recovered |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| headache | General disorders | Systematic Assessment |
| ||
| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| pyrexia | General disorders | Systematic Assessment |
| ||
| oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| otitis media | Ear and labyrinth disorders | Systematic Assessment |
| ||
| vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Meda Pharmaceuticals requests that it receive copies of any intended communication at least 15 working days for an abstract or oral presentation and 45 working days for a manuscript). This is to allow Meda Pharmaceuticals to review the communications for accuracy , to verify that confidential information is not being inadvertently divulged, to provide any relevant supplementary information, and to allow establishment of co-authorship.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Nancy Ruiz, MD | Meda Pharmaceuticals | 732 564 2390 | nancy.ruiz@meda.us |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| 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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| >=65 years |
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| Male |
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