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

Completed · Phase 3 · Has a placebo group

Conditions studied: Allergic Rhinitis

In brief

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.

Key facts

Study ID

NCT01697956

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

99

Starts

2012-10-01

Expected to finish

2013-02-01

Last updated by the study team

2015-10-08

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Teva Investigational Site 10305 — Long Beach, California, United States
• Teva Investigational Site 10304 — Stockbridge, Georgia, United States
• Teva Investigational Site 10300 — Plymouth, Minnesota, United States
• Teva Investigational Site 10302 — Normal Square, Pennsylvania, United States
• Teva Investigational Site 10301 — New Braunfels, Texas, United States
• Teva Investigational Site 10303 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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