Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Patients 12 Years and Older With SAR
NCT ID: NCT00854360
Last Updated: 2012-05-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
487 participants
INTERVENTIONAL
2009-03-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BDP HFA 80 µg/day
During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 micrograms (µg) BDP HFA and two actuations of placebo HFA once daily.
Beclomethasone dipropionate HFA Nasal Aerosol
Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol
Placebo
HFA Vehicle Aerosol
BDP HFA 160 µg/day
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
Beclomethasone dipropionate HFA Nasal Aerosol
Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol
BDP HFA 320 µg/day
During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
Beclomethasone dipropionate HFA Nasal Aerosol
Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol
Placebo
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
Placebo
HFA Vehicle Aerosol
Interventions
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Beclomethasone dipropionate HFA Nasal Aerosol
Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol
Placebo
HFA Vehicle Aerosol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study.
* A history of SAR to relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study Screening Visit (SV). The SAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and in the investigator's judgment is expected to be exposed to the allergen and require treatment throughout the entire study period.
* A demonstrated sensitivity to relevant tree/grass pollen known to produce SAR through a standard skin prick test. A positive test is defined as a wheal diameter at least 3 mm larger than the control wheal for the skin prick test. Documentation of a positive result within 12 months prior to Screening Visit (SV) is acceptable.
* Other criteria apply
Exclusion Criteria
* History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the SV).
* History of a respiratory infection or disorder \[including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)\] within the 14 days preceding the Screening Visit (SV), or development of a respiratory infection during the Run-in Period.
* Use of any prohibited concomitant medications within the prescribed (per protocol) time since the last dosing period prior to the Screening Visit (SV) and/or plans for use during the entire treatment duration.
* Other criteria apply
12 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sudeesh Tantry, Ph.D.
Role: STUDY_CHAIR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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Teva Global Respiratory Research Study Site
Mission Viejo, California, United States
Teva Global Respiratory Research Study Site
San Diego, California, United States
Teva Global Respiratory Research Study Site
San Diego, California, United States
Teva Global Respiratory Research Study Site
Colorado Springs, Colorado, United States
Teva Global Respiratory Research Study Site
Denver, Colorado, United States
Teva Global Respiratory Research Study Site
Gainesville, Georgia, United States
Teva Global Respiratory Research Study Site
Savannah, Georgia, United States
Teva Global Respiratory Research Study Site
Indianapolis, Indiana, United States
Teva Global Respiratory Research Study Site
Overland Park, Kansas, United States
Teva Global Respiratory Research Study Site
Bethesda, Maryland, United States
Teva Global Respiratory Research Study Site
St Louis, Missouri, United States
Teva Global Respiratory Research Study Site
Brick, New Jersey, United States
Teva Global Respiratory Research Study Site
Raleigh, North Carolina, United States
Teva Global Respiratory Research Study Site
Medford, Oregon, United States
Teva Global Respiratory Research Study Site
Portland, Oregon, United States
Teva Global Respiratory Research Study Site
Blue Bell, Pennsylvania, United States
Teva Global Respiratory Research Study Site
Pittsburgh, Pennsylvania, United States
Teva Global Respiratory Research Study Site
Upland, Pennsylvania, United States
Teva Global Respiratory Research Study Site
Charleston, South Carolina, United States
Teva Global Respiratory Research Study Site
Austin, Texas, United States
Teva Global Respiratory Research Study Site
Dallas, Texas, United States
Teva Global Respiratory Research Study Site
New Braunfels, Texas, United States
Teva Global Respiratory Research Study Site
San Antonio, Texas, United States
Teva Global Respiratory Research Study Site
Draper, Utah, United States
Teva Global Respiratory Research Study Site
Burke, Virginia, United States
Teva Global Respiratory Research Study Site
Richmond, Virginia, United States
Countries
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References
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Raphael GD, Berger WE, Prenner BM, Finn AF Jr, Kelley L, Tantry SK. Efficacy, safety, and optimal dose selection of beclomethasone dipropionate nasal aerosol for seasonal allergic rhinitis in adolescents and adults. Curr Med Res Opin. 2013 Oct;29(10):1329-40. doi: 10.1185/03007995.2013.821055. Epub 2013 Aug 6.
Other Identifiers
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BDP-AR-201
Identifier Type: -
Identifier Source: org_study_id
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