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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Richmond, Virginia
2268
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Richmond, VA
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616
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Ashland, OR
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Blue Bell, Pennsylvania
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Blue Bell, PA
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1166
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Boerne, TX
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2428
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Brick, NJ
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2269
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Burke, VA
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2047
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Canton, OH
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Centennial, Colorado
818
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Centennial, CO
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Charleston, South Carolina
2184
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Charleston, SC
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Cincinnati, Ohio
1880
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Cincinnati, OH
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2032
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Cleveland, OH
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Colorado Springs, Colorado
802
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Colorado Springs, CO
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Columbia, Missouri
1459
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Columbia, MO
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Corning, New York
2272
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Corning, NY
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Cortland, New York
2317
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Cortland, NY
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Costa Mesa, California
28
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Costa Mesa, CA
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1224
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Dallas, TX
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1673
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Dekalb, IL
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Downey, California
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Downey, CA
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686
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El Paso, TX
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High Point, North Carolina
2141
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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
27
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Huntington Beach, CA
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Indianapolis, Indiana
1793
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Indianapolis, IN
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1137
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Kerrville, TX
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Knoxville, Tennessee
1923
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Knoxville, TN
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Lawrenceville, Georgia
1939
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Lawrenceville, GA
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Louisville, Kentucky 40291
1822
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Louisville, KY
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Medford, Oregon 97504
627
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Medford, OR
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Middleburg Heights, Ohio
2025
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Mission Viejo, California
36
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Mission Viejo, CA
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Missoula, Montana
908
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Missoula, MT
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Niagara Falls, New York
2172
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Niagara Falls, NY
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1647
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Normal, IL
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North Dartmouth, Massachusetts
2585
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North Dartmouth, MA
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Orange, California
21
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Orange, CA
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Orangeburg, South Carolina
2121
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Paramount, California
15
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Paramount, CA
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1227
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Plano, TX
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Portland, Oregon
827
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Portland, OR
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Rochester, New York
2245
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Rochester, NY
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Salt Lake City, Utah
570
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San Antonio, Texas
1188
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San Diego, California
105
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San Diego, CA
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Savannah, Georgia 31406
2131
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Stockbridge, Georgia
1930
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Stockton, California
324
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Stockton, CA
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Traverse City, Michigan
1864
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Upland, Pennsylvania
2343
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Upland, PA
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1221
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Waco, TX
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Warwick, Rhode Island
2562
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Warwick, RI
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Watertown, New York
2333
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Watertown, NY
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