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
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Cortland, New York
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Blue Bell, Pennsylvania
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Cincinnati, Ohio
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High Point, North Carolina
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Indianapolis, Indiana
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Lawrenceville, Georgia
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Louisville, Kentucky 40291
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Medford, Oregon 97504
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Normal, IL
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Savannah, Georgia 31406
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