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| Name | Class |
|---|---|
| United BioSource, LLC | INDUSTRY |
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This study will be a prospective observational study of "real world" BDP nasal aerosol users with PAR, with or without seasonal allergic rhinitis (SAR). Subjects will respond to monthly online surveys regarding rhinitis control, concomitant medical conditions, concomitant (non-AR) medications, current AR therapy, and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perennial Allergic Rhinitis patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beclomethasone Dipropionate (BDP) Nasal Aerosol | Drug | BDP nasal aerosol 320 mcg/day will be administered to all patients as 2 sprays in each nostril once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Rhinitis Control Assessment Test (RCAT) Score | The RCAT will be completed each month and uses a one-week recall period. This questionnaire has six items that ask about nasal and other allergy symptoms and the control of these symptoms. Each question is responded to on a scale of 1-5. The responses are summed to evaluate a total score. A higher score (22-30) indicates that symptoms are well controlled. A lower score (5-21) indicates that rhinitis symptoms are not well controlled. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) score | The TSQM-9 asks patients about their level of satisfaction or dissatisfaction with the medication they are taking in the study. The 3 subscales (effectiveness, convenience, global satisfaction) are rated separately, and there is no overall score. 7 questions have responses ranging from 1=extremely dissatisfied/difficult/inconvenient to 7=extremely satisfied/easy/convenient. 2 questions have responses ranging from 1=not at all confident/certain to 5=extremely confident/certain. Higher scores indicate greater satisfaction with the medication. |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female patients, at least 12 years of age, with a diagnosis of PAR for at least one year and who are newly prescribed BDP nasal aerosol.
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| Name | Affiliation | Role |
|---|---|---|
| Mark Lepore, MD | Teva Pharmaceutical Industries, Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 024 | Little Rock | Alaska | United States | |||
| Teva Investigational Site 028 |
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|
| Baseline and 6 months |
| Change in the Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Allergy-specific (WPAI-CIQ-AS) score | The WPAI-CIQ-AS is a 9-item, patient-reported scale that asks about the amount of time lost from work or academic classes due to allergies, as well as the impact of allergies on performing work in the workplace or in school or attending classes. It also asks about the effect of allergies on other usual daily activities. All questions ask for recall of the last 7 days. Outcomes are expressed as impairment percentages, with higher scores indicating greater impairment and less productivity. | Baseline and 6 months |
| Change in the Pittsburgh Sleep Quality Index (PSQI) score | The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1 month interval. 19 items generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, daytime dysfunction. The scores of these components yield a "global score". A global score of 5 or greater indicates a poor sleeper. | Baseline and 6 months |
| Change in the Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) score | This 14-item scale covers 5 domains: activity limitations, practical problems, nose symptoms, eye symptoms, other symptoms. Responses range from 0=not troubled to 6=extremely troubled. 5 component scores and a global score are calculated. Higher scores indicate being more troubled as a result of nose/eye symptoms during the past week. | Baseline and 6 months |
| Change in overall healthcare utilization | Medical resources include in-patient care (hospitalizations, days of hospitalization), emergency room, and out-patient visits to physicians and other healthcare providers. The health services utilization survey asks for a 3 month recall and will be completed at baseline and months 3, 6, 9, and 12. | Baseline and 6 months |
| Change in number of non-intranasal corticosteroids (INS) medications for allergic rhinitis (AR) | Baseline and 6 months |
| Phoenix |
| Arizona |
| United States |
| Teva Investigational Site 003 | Encinitas | California | United States |
| Teva Investigational Site 042 | Fresno | California | United States |
| Teva Investigational Site 006 | Los Angeles | California | United States |
| Teva Investigational Site 017 | Orange | California | United States |
| Teva Investigational Site 007 | Palmdale | California | United States |
| Teva Investigational Site 021 | Paramount | California | United States |
| Teva Investigational Site 040 | Redwood City | California | United States |
| Teva Investigational Site 014 | Tallahassee | Florida | United States |
| Teva Investigational Site 010 | Tamarac | Florida | United States |
| Teva Investigational Site 038 | Albany | Georgia | United States |
| Teva Investigational Site 031 | Lawrenceville | Georgia | United States |
| Teva Investigational Site 035 | Savannah | Georgia | United States |
| Teva Investigational Site 043 | Fort Mitchell | Kentucky | United States |
| Teva Investigational Site 034 | Owensboro | Kentucky | United States |
| Teva Investigational Site 033 | Mandeville | Louisiana | United States |
| Teva Investigational Site 004 | Bethesda | Maryland | United States |
| Teva Investigational Site 037 | Novi | Michigan | United States |
| Teva Investigational Site 026 | Omaha | Nebraska | United States |
| Teva Investigational Site 002 | Brick | New Jersey | United States |
| Teva Investigational Site 019 | Corning | New York | United States |
| Teva Investigational Site 018 | New York | New York | United States |
| Teva Investigational Site 039 | Niagara Falls | New York | United States |
| Teva Investigational Site 011 | High Point | North Carolina | United States |
| Teva Investigational Site 027 | Winston-Salem | North Carolina | United States |
| Teva Investigational Site 030 | Winston-Salem | North Carolina | United States |
| Teva Investigational Site 013 | Toledo | Ohio | United States |
| Teva Investigational Site 022 | Ashland | Oregon | United States |
| Teva Investigational Site 016 | Eugene | Oregon | United States |
| Teva Investigational Site 032 | Havertown | Pennsylvania | United States |
| Teva Investigational Site 025 | Normal Square | Pennsylvania | United States |
| Teva Investigational Site 012 | Pittsburgh | Pennsylvania | United States |
| Teva Investigational Site 023 | Upland | Pennsylvania | United States |
| Teva Investigational Site 015 | Dallas | Texas | United States |
| Teva Investigational Site 029 | Dallas | Texas | United States |
| Teva Investigational Site 009 | Fort Worth | Texas | United States |
| Teva Investigational Site 020 | Houston | Texas | United States |
| Teva Investigational Site 041 | San Antonio | Texas | United States |
| Teva Investigational Site 044 | San Antonio | Texas | United States |
| Teva Investigational Site 046 | San Antonio | Texas | United States |
| Teva Investigational Site 001 | Waco | Texas | United States |
| Teva Investigational Site 005 | Murray | Utah | United States |
| Teva Investigational Site 045 | Newport News | Virginia | United States |
| Teva Investigational Site 008 | Puyallup | Washington | United States |
| Teva Investigational Site 036 | Greenfield | Wisconsin | United States |
| 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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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| C048053 | alpha-ketoisovalerate dehydrogenase phosphatase |
| D059085 | Nasal Sprays |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
| D000336 | Aerosols |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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