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The purpose of this study is to compare the effectiveness of an Investigational use of an allergy medication (MP03-33) used to treat perennial allergic rhinitis (PAR) to placebo (a nasal spray that contains no medicine). In addition, the study will also compare the safety and effectiveness of an investigational use of another allergy medication (MP03-36) used to treat perennial allergic rhinitis to placebo.
in Children Ages >6 to <12 with Perennial Allergic Rhinitis (PAR)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MP03-36 (0.15% solution) | Active Comparator | 822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks |
|
| MP03-33 (0.10% solution) | Active Comparator | 548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks |
|
| Placebo | Placebo Comparator | 0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azelastine hydrochloride nasal spray 0.15% | Drug | 822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) for the Entire 28-day Study Period Compared to Placebo | Change from baseline in 12-hour reflective total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms. | baseline to 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Instantaneous Total Nasal Symptoms Score (TNSS) for the Entire 28-day Study Period Compared to Placebo | change from baseline in 12-hour instantaneous total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms. | baseline to 28 days |
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Inclusion Criteria:
Male and female subjects >6-<12, inclusive at the screening visit
At least a 1-year history of PAR
The parent must provide written informed consent and the child must provide written assent.
Willing and able to comply with the study requirements
The presence of immunoglobulin E (IgE)-mediated hypersensitivity to dust mite, cockroach, mold, cat or dog dander, confirmed by a positive response to skin prick testing at the Visit 1. A positive response is defined as a wheal diameter of ≥5 mm larger than the negative control for the skin prick test. Histamine control must also be positive with a wheal diameter >5 mm larger than the control. If there are prevailing seasonal allergies, the subject must have a negative skin test to the specific allergen.
Screening Visit: Have a 12-hour reflective TNSS of at least 6 out of a possible 12 and a congestion score of ≥2 or a rhinorrhea score of ≥2 on Visit 1
Randomization Visit: to be eligible for entry into the double-blind treatment period, subjects/caregivers must record:
at least 3 symptom assessments (either AM or PM score) during the past 3 days of the Lead-In Period or the Day of Randomization:
the total of the seven Lead-In symptom assessments during the past 3 days of the Lead-In Period including the Day of Randomization (Visit 2/Day 1):
Must have taken at least 10 doses of study medication during the placebo Lead-In Period
General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor's medical officer
Subjects receiving immunotherapy injections (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit (adjustments to regimen following a brief period of missed injections do not preclude participation). Subjects receiving sublingual immunotherapy are excluded. A 6 month washout period is required following the last dose of sublingual immunotherapy.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Ginsberg, DO | Meda Phamaceuticals, Sr.Dir Medical and Scientific Affairs | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Clinical Trials | Costa Mesa | California | 92626 | United States | ||
| Allergy, Asthma and Respiratory Care Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | MP03-36 (0.15% Solution) | 822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks |
| FG001 | MP03-33 (0.10% Solution) | 548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Azelastine hydrochloride nasal spray 0.10% | Drug | 548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks |
|
|
| Placebo | Drug | 0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks |
|
| Change From Baseline in 12-hour Reflective Total Ocular Symptoms Score (TOSS) and Instantaneous Total Ocular Symptoms Score (TOSS) for the Entire 28-day Study Period Compared to Placebo | change from baseline in 12-hour instantaneous total ocular symptom score (TOSS) for the entire 28-day study period compared to placebo,scored on a 0 to 18 scale with 0 being no symptoms and 18 being severe symptoms. | baseline to 28 days |
| Change From Baseline to Visit 4 in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Compared to Placebo | change from baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) compared to placebo for the entire 28-day study period compared to placebo,scored on a 0 to 42 scale with 0 being not troubled at all and 42 being extremely troublesome. | baseline to 28 Days |
| Long Beach |
| California |
| 90806 |
| United States |
| Southern California Research | Mission Viejo | California | 92691 | United States |
| Joann Blessing-Moore,MD | Palo Alto | California | 94304 | United States |
| Capital Allergy and Respiratory Disease Center | Sacramento | California | 95819 | United States |
| Allergy and Asthma Medical Group and Research Center | San Diego | California | 92123 | United States |
| Allergy & Asthma Associates of Santa Clara Valley Research Cntr | San Jose | California | 95117 | United States |
| Bensch Research Associates | Stockton | California | 95207 | United States |
| Colorado Allergy and Asthma Centers, PC | Denver | Colorado | 80230 | United States |
| Center for Allergy, Asthma and Immunology | Waterbury | Connecticut | 06708 | United States |
| Clinical Research Atlanta | Atlanta | Georgia | 30342 | 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 |
| Chesapeake Clinical Research, Inc | Baltimore | Maryland | 21236 | United States |
| Respiratory Medicine Research Institute of Michigan | Ypsilanti | Michigan | 48197 | United States |
| Clinical Research Institute | Plymouth | Minnesota | 55402 | United States |
| Asthma and Allergy Center, PC | Papillion | Nebraska | 68046 | United States |
| Princeton Center for Clinical Research | Skillman | New Jersey | 08558 | United States |
| Asthma, Sinus & Allergy Centers, LLC | Warren Township | New Jersey | 07059 | United States |
| Island Medical Research | Rockville Centre | New York | 11570 | United States |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | United States |
| Bernstein Clinical Research Center | Cincinnati | Ohio | 45231 | United States |
| Toledo Center for Clinical Research | Sylvania | Ohio | 43560 | 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 Asthma, Allergy and Dermatology Research Center, LLC | Lake Oswego | Oregon | 97035 | United States |
| Allergy Associated Research Center | Portland | Oregon | 97213 | United States |
| Allergy and Asthma Consultants of NJ-PA, P.C | Collegeville | Pennsylvania | 19426 | United States |
| Allergy and Asthma Consultants, LLP | Charleston | South Carolina | 29414 | United States |
| Isis Clinical Research, LLC | Ausitn | Texas | 78731 | United States |
| Central Texas Clinical Research | Austin | Texas | 78705 | United States |
| Sirius Clinical Research | Austin | Texas | 78759 | United States |
| Pharmaceutical Research & Consulting Inc | Dallas | Texas | 75231 | United States |
| Western Sky Medical Research | El Paso | Texas | 79902 | United States |
| Sylvana Research Associates | San Antonio | Texas | 78229 | United States |
| Intermountain Clinical Research | Draper | Utah | 84020 | United States |
| Marycliff Allergy Specialists | Spokane | Washington | 99204 | United States |
| Gary Steven, MD | Greenfield | Wisconsin | 53228 | United States |
| FG002 | Placebo | 0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MP03-36 (0.15% Solution) | 822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks |
| BG001 | MP03-33 (0.10% Solution) | 548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks |
| BG002 | Placebo | 0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| 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 | Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) for the Entire 28-day Study Period Compared to Placebo | Change from baseline in 12-hour reflective total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms. | participant must have had at least one post baseline efficacy assessment | Posted | Least Squares Mean | Standard Deviation | units on a scale | baseline to 28 Days |
|
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| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Instantaneous Total Nasal Symptoms Score (TNSS) for the Entire 28-day Study Period Compared to Placebo | change from baseline in 12-hour instantaneous total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms. | participant must have had at least one post baseline efficacy assessment | Posted | Least Squares Mean | Standard Deviation | units on a scale | baseline to 28 days |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 12-hour Reflective Total Ocular Symptoms Score (TOSS) and Instantaneous Total Ocular Symptoms Score (TOSS) for the Entire 28-day Study Period Compared to Placebo | change from baseline in 12-hour instantaneous total ocular symptom score (TOSS) for the entire 28-day study period compared to placebo,scored on a 0 to 18 scale with 0 being no symptoms and 18 being severe symptoms. | participant must have had at least one post baseline efficacy assessment | Posted | Least Squares Mean | Standard Deviation | units on a scale | baseline to 28 days |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Visit 4 in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Compared to Placebo | change from baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) compared to placebo for the entire 28-day study period compared to placebo,scored on a 0 to 42 scale with 0 being not troubled at all and 42 being extremely troublesome. | participant must have had at least one post baseline efficacy assessment | Posted | Least Squares Mean | Standard Deviation | units on a scale | baseline to 28 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 | MP03-36 (0.15% Solution) | 822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks | 0 | 161 | 39 | 161 | ||
| EG001 | MP03-33 (0.10% Solution) | 548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks | 0 | 166 | 35 | 166 | ||
| EG002 | Placebo | 0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks | 0 | 162 | 37 | 162 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| epistaxis | Respiratory, thoracic and mediastinal disorders | medra | Non-systematic Assessment |
| |
| nasal discomfort | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| dysgeusia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| uri | Infections and infestations | Non-systematic Assessment |
| ||
| sneezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| pyrexia | General disorders | Non-systematic Assessment |
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| abdominal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
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| nasopharynigitis | Infections and infestations | Non-systematic Assessment |
| ||
| headache | Nervous system disorders | Non-systematic Assessment |
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| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| otitis media | Infections and infestations | Non-systematic Assessment |
| ||
| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| pharyngitis streptoccal | Infections and infestations | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr.Director Medical Scientific Affairs | Meda Pharmaceuticals Inc | 732 564 2200 | David.ginsberg@meda.us |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| 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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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Participants |
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| Participants |
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