Hypothalamic-Pituitary-Adrenal (HPA)-Axis Study in Pediatric Subjects With Perennial Allergic Rhinitis (PAR)



Status:Completed
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:6 - 11
Updated:4/21/2016
Start Date:October 2012
End Date:February 2013

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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 6-Week Study Designed to Investigate the Effects of BDP Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA)-Axis in Pediatric Subjects (6 to 11 Years of Age) With Perennial Allergic Rhinitis (PAR)

The purpose of this study is to compare the effect of 6 weeks of treatment with
beclomethasone dipropionate (BDP) nasal aerosol versus placebo on HPA-axis function, as
assessed by 24-hour serum cortisol weighted mean, and to evaluate the safety and
tolerability of BDP nasal aerosol, in subjects 6 to 11 years of age with perennial allergic
rhinitis.


Inclusion Criteria:

- Informed consent/(assent - if applicable)

- Male or female subjects 6-11 years of age

- General good health

- A documented history of PAR to a relevant perennial allergen for a minimum of 12
months

- Other criteria apply

Exclusion Criteria:

- Pregnancy, nursing, or plans to become pregnant or donate gametes

- Participation in any investigational drug study within the 30 days preceding the
Screening Visit 1 (SV1)

- Previous participation in a BDP nasal aerosol study as a randomized subject

- A known hypersensitivity to any corticosteroid or any of the excipients in the study
medication formulation

- History of physical findings of nasal pathology, including nasal polyps or other
clinically significant respiratory tract malformations

- History of a respiratory infection or disorder within the 14 days preceding the
Screening Visit 1 (SV1)

- Use of any prohibited concomitant medications within the prescribed (per protocol)
withdrawal periods prior to the Screening Visit 1 (SV1)

- Other criteria apply

- Current smoker or current user of tobacco products at any time during the study;
history of smoking or use of tobacco products within the past year
We found this trial at
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San Antonio, Texas
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Long Beach, California
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Normal, Pennsylvania
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Plymouth, Minnesota
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Stockbridge, Georgia
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Stockbridge, GA
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