CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 89 enrolled
Drug / intervention
ciclesonide nasal aerosol +1 moredrug
Likely dose
ciclesonide nasal aerosol 74 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/NCT01378429
NCT01378429Phase 3Completed
CompareCT.gov

A 6-Week Randomized, Double-blind, Placebo-controlled, Parallel Group, Safety Study of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA) Axis in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR)

Sumitomo Pharma America, Inc.·interventional·Posted Jun 22, 2011·Updated May 26, 2014

In Brief

A Phase 3 clinical trial evaluating ciclesonide nasal aerosol and Placebo for Perennial Allergic Rhinitis and PAR. Completed, enrolled 89 participants across 7 sites.

Detailed Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.

Study Details

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

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2011
Enrollment StartJul 1, 2011
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.0 years ago

Interventions

ciclesonide nasal aerosoldrug

ciclesonide nasal aerosol (74 mcg)

Placebodrug

Placebo