Study of an Investigational Nasal Aerosol or Placebo in Children (Ages 4 to 11) With Perennial Allergic Rhinitis (PAR)



Status:Completed
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:4 - 11
Updated:4/21/2016
Start Date:January 2013
End Date:October 2013

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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week, Clinical Study Designed to Assess the Efficacy and Safety of BDP Nasal Aerosol (80 mcg, Once Daily) in Pediatric Subjects (4 to 11 Years of Age) With PAR

The purpose of this study is to evaluate the efficacy and safety of Beclomethasone
dipropionate (BDP) nasal aerosol in subjects with Perennial Allergic Rhinitis (PAR).


Inclusion Criteria:

- Male or female subjects 4 to 11 years of age, inclusive, as of the Screening Visit
(SV).

- A documented history of PAR to a relevant perennial allergen for a minimum of 12
months (6 months for subjects 4 to 5 years of age) immediately preceding the study
Screening Visit (SV).

- A demonstrated sensitivity to at least one allergen known to induce PAR through a
standard skin prick test.

- 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 (e.g., nasal piercing) or surgery, atrophic rhinitis, or rhinitis
medicamentosa (all within the last 60 days prior to the Screening Visit [SV]).

- 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 of the following 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.
We found this trial at
53
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2314
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Burke, VA
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375
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Ashland, OR
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Blue Bell, Pennsylvania
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Blue Bell, PA
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1758
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Boerne, TX
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2416
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Brick, NJ
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2057
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Canton, OH
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Centennial, Colorado
1030
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Centennial, CO
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Charleston, South Carolina
2423
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Charleston, SC
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Cincinnati, Ohio
1967
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Cincinnati, OH
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2020
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Cleveland, OH
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Colorado Springs, Colorado
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Columbia, Missouri
1611
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Columbia, MO
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Corning, New York
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Cortland, New York
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Costa Mesa, California
992
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1681
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Dallas, TX
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1679
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Dekalb, IL
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Downey, California
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Downey, CA
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1377
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El Paso, TX
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High Point, North Carolina
2291
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High Point, NC
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Holly Springs, North Carolina
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Hot Springs, Arkansas
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Huntington Beach, California
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Indianapolis, Indiana
1868
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Indianapolis, IN
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1729
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Kerrville, TX
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Knoxville, Tennessee
2110
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Lawrenceville, Georgia
2188
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Lawrenceville, GA
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Louisville, Kentucky 40291
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Medford, Oregon 97504
366
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Medford, OR
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Middleburg Heights, Ohio
2019
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Mission Viejo, California
998
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Missoula, Montana
394
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Missoula, MT
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Niagara Falls, New York
2096
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Niagara Falls, NY
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1712
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Normal, IL
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North Dartmouth, Massachusetts
2511
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Orange, California
984
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Orange, CA
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Orangeburg, South Carolina
2351
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Paramount, California
974
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Paramount, CA
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1673
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Plano, TX
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Portland, Oregon
147
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Richmond, Virginia
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Rochester, New York
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Rochester, NY
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Salt Lake City, Utah
701
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Salt Lake City, UT
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San Antonio, Texas
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San Diego, California
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Savannah, Georgia 31406
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Stockbridge, Georgia
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Stockton, California
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Traverse City, Michigan
1750
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Upland, Pennsylvania
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1726
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Waco, TX
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Warwick, Rhode Island
2489
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Watertown, New York
2216
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