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

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