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

NCT01133626 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2012-07-04

Study results available
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Summary

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

Conditions

  • Perennial Allergic Rhinitis

Interventions

DRUG

Placebo Nasal Aerosol

Placebo nasal aerosol administered daily for 42 days of treatment

DRUG

Prednisone capsules

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

DRUG

Placebo Prednisone Capsules

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

DRUG

Beclomethasone dipropionate

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

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Sudeesh K. Tantry, Ph.D. · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01133626 on ClinicalTrials.gov