CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 107 enrolled
Drug / intervention
Placebo Nasal Aerosol +3 moredrug
Likely dose
Prednisone capsules 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01133626
NCT01133626Phase 3Completed
CompareCT.gov

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)

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted May 31, 2010·Updated Jul 4, 2012

In Brief

A Phase 3 clinical trial evaluating Placebo Nasal Aerosol, Prednisone capsules, and 2 other interventions for Perennial Allergic Rhinitis. Completed, enrolled 107 participants across 3 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPerennial Allergic Rhinitis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 31, 2010
Enrollment StartJun 1, 2010
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.1 years ago

Interventions

Placebo Nasal Aerosoldrug

Placebo nasal aerosol administered daily for 42 days of treatment

Prednisone capsulesdrug

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

Placebo Prednisone Capsulesdrug

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

Beclomethasone dipropionatedrug

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