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To compare safety and efficacy of Perrigo's steroid drug product compared with an FDA approved steroid drug product in the treatment of subjects with seasonal allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product | Experimental | Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Perrigo |
|
| Reference Product | Active Comparator | Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Meda |
|
| Placebo Product | Placebo Comparator | Placebo nasal spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray | Drug | 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline for Mean Reflective Total Nasal Symptom Score (rTNSS) | The symptoms included in the reflective Total Nasal Symptom Score (rTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12. | Day 1 through Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the Mean Instantaneous Total Nasal Symptom Score (iTNSS) | The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta Allergy & Asthma Clinic, PA | Stockbridge | Georgia | 30281 | United States | ||
| Clinical Research Atlanta (CRA) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product | Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Perrigo |
| FG001 | Reference Product | Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray Meda |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 2, 2014 | Nov 10, 2020 |
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| Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray | Drug | 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate |
|
|
| Placebo nasal spray | Drug | Placebo nasal spray |
|
| Day 1 through Day 14 |
| Change From Baseline iTNSS Scores on Day 1 Post First Randomized Dose | This outcome measured the time to statistical significance of the reduction of signs/symptoms over a 4 hour period on Day 1 only by measuring the reduction in iTNSS scores. When the change from baseline was statistically significant, it was associated with a time to onset of the anti-histamine component of the formulation. Subjects will record iTNSS scores for 4 hours post first randomized dose. The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12. | Day 1, up to four hours post the first dose |
| Stockbridge |
| Georgia |
| 30281 |
| United States |
| Family Allergy and Asthma Research Institute | Louisville | Kentucky | 40215 | United States |
| Chesapeake Clinical Research, Inc. | Baltimore | Maryland | 21236 | United States |
| NEMRA Northeast Medical Research Associates, Inc | North Dartmouth | Massachusetts | 02747 | United States |
| Clinical Research Institute, Inc. | Minneapolis | Minnesota | 55402 | United States |
| Clinical Research Institute LLC | Minneapolis | Minnesota | 63141 | United States |
| Clinical Research of the Ozarks, Inc. | Columbia | Missouri | 65203 | United States |
| Clinical Research of the Ozarks, Inc. | Rolla | Missouri | 65401 | United States |
| The Clinical Research Center, LLC | St Louis | Missouri | 63141 | United States |
| Princeton Center for Clinical Research | Skillman | New Jersey | 08558 | United States |
| Island Medical Research, P.C. | Rockville Centre | New York | 11570 | United States |
| Allergy and Asthma Center of NC | High Point | North Carolina | 27262 | United States |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | United States |
| Toledo Center for Clinical Research | Sylvania | Ohio | 43560 | United States |
| Allergy, Asthma & Clinical Research Center | Oklahoma City | Oklahoma | 73120 | United States |
| Vital Prospects Clinical Research Institute, P.C. | Tulsa | Oklahoma | 74136 | United States |
| National Allergy, Asthma & Urticaria Centers of Charleston | North Charleston | South Carolina | 29420 | United States |
| New Phase Research and Development | Knoxville | Tennessee | 37919 | United States |
| ISIS Clinical Research, LLC | Austin | Texas | 78731 | United States |
| Sirius Clinical Research LLC | Austin | Texas | 78759 | United States |
| AARA Research Center | Dallas | Texas | 75231 | United States |
| Pharmaceutical Research & Consulting Inc. | Dallas | Texas | 75231 | United States |
| Western Sky Medical Research | El Paso | Texas | 79904 | United States |
| Central Texas Health Research | New Braunfels | Texas | 78130 | United States |
| Quality Research Inc. | San Antonio | Texas | 78209 | United States |
| Diagnostics Research Group | San Antonio | Texas | 78229 | United States |
| Sylvana Research Associates | San Antonio | Texas | 78257 | United States |
| Allergy Asthma Research Institute | Waco | Texas | 76712 | United States |
| The Asthma & Allergy Center - Bellevue | Bellevue | Washington | 68123 | United States |
| FG002 | Placebo Product | Placebo nasal spray |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Product | Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate |
| BG001 | Reference Product | Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate |
| BG002 | Placebo Product | Placebo nasal spray Placebo nasal spray |
| BG003 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Mean Change From Baseline for Mean Reflective Total Nasal Symptom Score (rTNSS) | The symptoms included in the reflective Total Nasal Symptom Score (rTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12. | Per protocol population | Posted | Mean | Standard Error | score on a scale | Day 1 through Day 14 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the Mean Instantaneous Total Nasal Symptom Score (iTNSS) | The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12. | per-protocol population | Posted | Mean | Standard Error | score on a scale | Day 1 through Day 14 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline iTNSS Scores on Day 1 Post First Randomized Dose | This outcome measured the time to statistical significance of the reduction of signs/symptoms over a 4 hour period on Day 1 only by measuring the reduction in iTNSS scores. When the change from baseline was statistically significant, it was associated with a time to onset of the anti-histamine component of the formulation. Subjects will record iTNSS scores for 4 hours post first randomized dose. The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 1, up to four hours post the first dose |
|
14 days
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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 | Test Product | Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate | 0 | 381 | 3 | 381 | 0 | 381 |
| EG001 | Reference Product | Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate | 0 | 376 | 1 | 376 | 0 | 376 |
| EG002 | Placebo Product | Placebo nasal spray Placebo nasal spray | 0 | 194 | 0 | 194 | 0 | 194 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fetal demise | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| cervical disc herniation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Infected cat bite | Infections and infestations | Non-systematic Assessment |
| ||
| suicidal ideations | Psychiatric disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Schwartz | Perrigo | 718-960-9900 | jonathan.schwartz@perrigo.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 2, 2014 | Nov 10, 2020 | SAP_000.pdf |
| 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 |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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