Study of an Investigational Nasal Aerosol or Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies
NCT ID: NCT01307319
Last Updated: 2015-02-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
715 participants
INTERVENTIONAL
2011-03-31
2011-08-31
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 mcg/day
Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
BDP HFA
BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) nasal aerosol administered as a single actuation in each nostril daily for the 15 day treatment period. Each actuation contains either 40 or 80 mcg for a total daily dose of either 80 or 160 mcg depending upon the assigned treatment arm.
BDP HFA 160 mcg/day
Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
BDP HFA
BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) nasal aerosol administered as a single actuation in each nostril daily for the 15 day treatment period. Each actuation contains either 40 or 80 mcg for a total daily dose of either 80 or 160 mcg depending upon the assigned treatment arm.
Placebo nasal aerosol once daily
Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
Placebo nasal aerosol
Placebo formulated as a nasal aerosol spray and administered as a single actuation in each nostril daily for the 15 day treatment period.
Interventions
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BDP HFA
BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) nasal aerosol administered as a single actuation in each nostril daily for the 15 day treatment period. Each actuation contains either 40 or 80 mcg for a total daily dose of either 80 or 160 mcg depending upon the assigned treatment arm.
Placebo nasal aerosol
Placebo formulated as a nasal aerosol spray and administered as a single actuation in each nostril daily for the 15 day treatment period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A documented history of SAR to a relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study Screening Visit (SV).
* A demonstrated sensitivity to at least one seasonal allergen (tree/grass pollen) known to induce SAR through a standard skin prick test.
* Other criteria apply
Exclusion Criteria
* History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, chronic sinusitis or influenza,) within the 14 days preceding the Screening Visit (SV), or development of a respiratory infection during the Run-in Period.
* Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta-agonists and any controller drug (e.g., theophylline, leukotriene antagonists). History of intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists prior to the Screening Visit (SV) is acceptable
* Have any conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial
* Other criteria apply
6 Years
11 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Locations
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Teva Clinical Study Site
Oxford, Alabama, United States
Teva Clinical Study Site
Bell, California, United States
Teva Clinical Study Site
Costa Mesa, California, United States
Teva Clinical Study Site
Mission Viejo, California, United States
Teva Clinical Study Site
Orange, California, United States
Teva Clinical Study Site
Paramount, California, United States
Teva Clinical Study Site
San Diego, California, United States
Teva Clinical Study Site
San Diego, California, United States
Teva Clinical Study Site
Stockton, California, United States
Teva Clinical Study Site
Centennial, Colorado, United States
Teva Clinical Study Site
Colorado Springs, Colorado, United States
Teva Clinical Study Site
Gainesville, Georgia, United States
Teva Clinical Study Site
Lawrenceville, Georgia, United States
Teva Clinical Study Site
Savannah, Georgia, United States
Teva Clinical Study Site
Stockbridge, Georgia, United States
Teva Clinical Study Site
Indianapolis, Indiana, United States
Teva Clinical Study Site
Bethesda, Maryland, United States
Teva Clinical Study Site
Minneapolis, Minnesota, United States
Teva Clinical Study Site
Plymouth, Minnesota, United States
Teva Clinical Study Site
Columbia, Missouri, United States
Teva Clinical Study Site
Rolla, Missouri, United States
Teva Clinical Study Site
Warrensburg, Missouri, United States
Teva Clinical Study Site
Bozeman, Montana, United States
Teva Clinical Study Site
Brick, New Jersey, United States
Teva Clinical Study Site
High Point, North Carolina, United States
Teva Clinical Study Site
Oklahoma City, Oklahoma, United States
Teva Clinical Study Site
Portland, Oregon, United States
Teva Clinical Study Site
Blue Bell, Pennsylvania, United States
Teva Clinical Study Site
Collegeville, Pennsylvania, United States
Teva Clinical Study Site
Philadelphia, Pennsylvania, United States
Teva Clinical Study Site
Pittsburgh, Pennsylvania, United States
Teva Clinical Study Site
Charleston, South Carolina, United States
Teva Clinical Study Site
Orangeburg, South Carolina, United States
Teva Clinical Study Site
Austin, Texas, United States
Teva Clinical Study Site
Dallas, Texas, United States
Teva Clinical Study Site
Dallas, Texas, United States
Teva Clinical Study Site
El Paso, Texas, United States
Teva Clinical Study Site
Fort Worth, Texas, United States
Teva Clinical Study Site
Houston, Texas, United States
Teva Clinical Study Site
Kerrville, Texas, United States
Teva Clinical Study Site
New Braunfels, Texas, United States
Teva Clinical Study Site
San Antonio, Texas, United States
Teva Clinical Study Site
Waco, Texas, United States
Teva Clinical Study Site
Burke, Virginia, United States
Teva Clinical Study Site
Richmond, Virginia, United States
Countries
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References
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Storms WW, Segall N, Mansfield LE, Amar NJ, Kelley L, Ding Y, Tantry SK. Efficacy and safety of beclomethasone dipropionate nasal aerosol in pediatric patients with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2013 Nov;111(5):408-414.e1. doi: 10.1016/j.anai.2013.07.033. Epub 2013 Aug 28.
Other Identifiers
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BDP-AR-305
Identifier Type: -
Identifier Source: org_study_id
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