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 |
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.
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
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