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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01697956
First received: September 28, 2012
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis
 Drug: Beclomethasone dipropionate (BDP) nasal aerosol
Drug: Placebo Nasal Aerosol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 24-Hour serum Cortisol weighted mean after 42 days of treatment [ Time Frame: Baseline to 42 days ] [ Designated as safety issue: No ]
    The primary endpoint is the 24-hour serum cortisol weighted mean for BDP nasal aerosol and placebo after forty two (42) days of treatment.


Estimated Enrollment: 99
Study Start Date: October 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Beclomethasone dipropionate (BDP) nasal aerosol Drug: Beclomethasone dipropionate (BDP) nasal aerosol
Dose: BDP 80 mcg/day (40 mcg/spray, 1 spray/nostril, once daily - total 2 sprays/day)
Other Name: QNASL (TM)
Placebo Comparator: Placebo Nasal Aerosol Drug: Placebo Nasal Aerosol
Dose: 1 spray/nostril, once daily - total 2 sprays/day

  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01697956

Locations
United States, California
Teva Investigational Site 10305
Long Beach, California, United States
United States, Georgia
Teva Investigational Site 10304
Stockbridge, Georgia, United States
United States, Minnesota
Teva Investigational Site 10300
Plymouth, Minnesota, United States
United States, Pennsylvania
Teva Investigational Site 10302
Normal, Pennsylvania, United States
United States, Texas
Teva Investigational Site 10301
New Braunfels, Texas, United States
Teva Investigational Site 10303
San Antonio, Texas, United States
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Principal Investigator: Sudeesh K Tantry, Ph.D. Teva Branded Pharmaceutical Products R&D
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01697956     History of Changes
Other Study ID Numbers: BDP-AR-307
Study First Received: September 28, 2012
Last Updated: May 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Pediatric Subjects

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Beclomethasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 23, 2013