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

Last updated: September 10, 2015
Sponsor: Teva Pharmaceutical Industries
Overall Status: Completed

Phase

3

Condition

Allergies & Asthma

Allergy (Pediatric)

Allergy

Treatment

N/A

Clinical Study ID

NCT01697956
BDP-AR-307
  • Ages 6-11
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 12months

  • Other criteria apply

Exclusion

Exclusion Criteria:

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

  • Participation in any investigational drug study within the 30 days preceding theScreening 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 studymedication formulation

  • History of physical findings of nasal pathology, including nasal polyps or otherclinically significant respiratory tract malformations

  • History of a respiratory infection or disorder within the 14 days preceding theScreening 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

Study Design

Total Participants: 99
Study Start date:
October 01, 2012
Estimated Completion Date:
February 28, 2013

Connect with a study center

  • Teva Investigational Site 10305

    Long Beach, California
    United States

    Site Not Available

  • Teva Investigational Site 10304

    Stockbridge, Georgia
    United States

    Site Not Available

  • Teva Investigative Site 10300

    Minneapolis, Minnesota
    United States

    Site Not Available

  • Teva Investigational Site 10300

    Plymouth, Minnesota
    United States

    Site Not Available

  • Teva Investigational Site 10302

    Normal, Pennsylvania
    United States

    Site Not Available

  • Teva Investigational Site 10301

    New Braunfels, Texas
    United States

    Site Not Available

  • Teva Investigational Site 10303

    San Antonio, Texas
    United States

    Site Not Available

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