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

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Pharmaceutical Industries
• Treatments: Beclomethasone

Criteria

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