Effectiveness of Beclomethasone Dipropionate Nasal Aerosol for Perennial Allergic Rhinitis
NCT ID: NCT01632540
Last Updated: 2014-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
824 participants
OBSERVATIONAL
2012-07-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Perennial Allergic Rhinitis patients
Beclomethasone Dipropionate (BDP) Nasal Aerosol
BDP nasal aerosol 320 mcg/day will be administered to all patients as 2 sprays in each nostril once daily.
Interventions
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Beclomethasone Dipropionate (BDP) Nasal Aerosol
BDP nasal aerosol 320 mcg/day will be administered to all patients as 2 sprays in each nostril once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 12 years or greater at time of enrollment
* Diagnosis of PAR for at least one year; and 2)a positive skin prick (ie, epicutaneous) or serum-specific IgE test within the past 2 years to a perennial allergen as appropriate for the location; and 3)PAR symptoms that are consistent with exposure to this allergen for at least one year
* Uncontrolled rhinitis symptoms at the time of assessment as confirmed by a score of 21 or less on the RCAT
* Newly prescribed BDP Nasal Aerosol (within the past 7 days but have not yet used)
* Willing and able to complete surveys in English on a computer with internet access
* Willing and able to provide informed consent prior to entering the study (or parent/caregiver/legal guardian if applicable)
Exclusion Criteria
* Rhinitis medicamentosa or nasal structural abnormalities (including nasal polyps and clinically significant septal deviation) that significantly interfere with nasal airflow
* Acute upper respiratory infection within the past 14 days
* Used any pressurized metered-dose inhaler INS product (including BDP Nasal Aerosol and Ciclesonide Nasal Aerosol) within the past 90 days
* Used any experimental therapy for AR within the past 30 days
* Any condition which the investigator feels may interfere with the study
12 Years
ALL
No
Sponsors
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United BioSource, LLC
INDUSTRY
Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Lepore, MD
Role: PRINCIPAL_INVESTIGATOR
Teva Pharmaceutical Industries, Ltd.
Locations
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Teva Investigational Site 024
Little Rock, Alaska, United States
Teva Investigational Site 028
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
Countries
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Other Identifiers
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BDP-AR-401
Identifier Type: -
Identifier Source: org_study_id
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