CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 847 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/NCT01458275
NCT01458275Phase 3Completed
CompareCT.gov

A 2-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6 to 11 Years With Seasonal Allergic Rhinitis

Sumitomo Pharma America, Inc.·interventional·Posted Oct 24, 2011·Updated May 15, 2014

In Brief

A Phase 3 clinical trial evaluating Ciclesonide nasal aerosol 37 mcg, ciclesonide nasal aerosol 74 mcg, and 1 other intervention for Seasonal Allergic Rhinitis. Completed, enrolled 847 participants across 66 sites.

Detailed Summary

This is a 2-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-old diagnosed with SAR.

Study Details

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

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 24, 2011
Enrollment StartNov 1, 2011
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 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 mcg

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 actuation per nostril