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Completed

NCT Number: NCT01133626

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

The purpose of the study is to evaluate the effects of BDP HFA Nasal Aerosol on HPA-axis function.

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Key information

Conditions

Perennial Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial

Age range

12 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Teva Clinical Study Site, North Dartmouth, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed Consent
  • Male or female subjects 12-45 years of age
  • Documented history of perennial allergic rhinitis
  • General good health
  • Other criteria apply

Exclusion criteria

  • History of physical findings of nasal pathology (within 60 days prior to Screening Visit 1)
  • Participation in any investigational drug study 30 days preceding Screening Visit 1
  • History of respiratory infection/disorder with 14 days preceding Screening Visit 1
  • Use of any prohibited concomitant medications

Treatment and study plan

Placebo Nasal Aerosol

Drug

Placebo nasal aerosol administered daily for 42 days of treatment

Prednisone capsules

Drug

Prednisone 10 mg capsule taken each day on the last 7 days of treatment

Placebo Prednisone Capsules

Drug

Placebo prednisone capsule taken each day on the last 7 days of treatment

Beclomethasone dipropionate

Drug

Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for 42 days.

Other names: QNASL(TM)

Primary outcomes

  1. The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment

    Time frame: Day 0 (Baseline), Day 42

    Geometric mean serum cortisol weighted mean values were calculated at baseline and after 6 weeks (42 days) of treatment. The geometric mean ratio of week 6 / baseline is reported. The primary outcome compares the BDP HFA and Placebo treatment arms. The comparison of active control (Placebo/Prednisone) and Placebo treatment arms is an "other pre-specified" outcome.

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, 6-Week Study Designed to Investigate the Effects of BDP HFA Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA) Axis When Administered in Adolescent and Adult Subjects (12 to 45 Years of Age) With Perennial Allergic Rhinitis (PAR)

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 31, 2010
Registry last updated
Jul 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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