CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 99 enrolled
Drug / intervention
BDP +1 moredrug
Likely dose
BDP 80 mcgfrom 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/NCT01697956
NCT01697956Phase 3Completed
CompareCT.gov

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)

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Oct 2, 2012·Updated Oct 8, 2015

In Brief

A Phase 3 clinical trial evaluating BDP and Placebo for Allergic Rhinitis. Completed, enrolled 99 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Rhinitis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 2, 2012
Enrollment StartOct 1, 2012
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 13.8 years ago

Interventions

BDPdrug

Beclomethasone dipropionate (BDP) 80 mcg/day (40 mcg/spray, 1 spray/nostril, once daily - total 2 sprays/day) as a nasal aerosol.

Placebodrug

Placebo (1 spray/nostril, once daily - total 2 sprays/day) as a nasal aerosol.