CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 848 enrolled
Drug / intervention
Ciclesonide nasal aerosol 37 mcg +2 moredrug
Likely dose
Ciclesonide nasal aerosol 37 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/NCT01451541
NCT01451541Phase 3Completed
CompareCT.gov

A 12-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis

Sumitomo Pharma America, Inc.·interventional·Posted Oct 13, 2011·Updated May 6, 2014

In Brief

A Phase 3 clinical trial evaluating Ciclesonide nasal aerosol 37 mcg, ciclesonide nasal aerosol 74 mcg, and 1 other intervention for Perennial Allergic Rhinitis and PAR. Completed, enrolled 848 participants across 60 sites.

Detailed Summary

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of ciclesonide nasal aerosol 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 PostedOct 13, 2011
Enrollment StartOct 1, 2011
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.7 years ago

Interventions

Ciclesonide nasal aerosol 37 mcgdrug

ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37

ciclesonide nasal aerosol 74 mcgdrug

ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg

Placebodrug

Placebo - one dose per nostril