CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,110 enrolled
Drug / intervention
Ciclesonide HFA 80 mcg +2 moredrug
Likely dose
Ciclesonide HFA 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/NCT00953147
NCT00953147Phase 3Completed
CompareCT.gov

A 6-Month Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of Once Daily Ciclesonide HFA Nasal Aerosol (80 and 160 μg) in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older

Sumitomo Pharma America, Inc.·interventional·Posted Aug 6, 2009·Updated Jun 13, 2012

In Brief

A Phase 3 clinical trial evaluating Ciclesonide HFA 80 mcg, Ciclesonide HFA 160 mcg, and 1 other intervention for Allergic Rhinitis and Perennial Allergic Rhinitis. Completed, enrolled 1,110 participants across 45 sites.

Detailed Summary

This is a 6-month multi-center, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide HFA nasal aerosol administered once-daily to male and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR).

Study Details

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

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 6, 2009
Enrollment StartAug 1, 2009
Primary CompletionJan 1, 2010
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.9 years ago

Interventions

Ciclesonide HFA 80 mcgdrug

Ciclesonide HFA Nasal Aerosol 80 mcg once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older.

Ciclesonide HFA 160 mcgdrug

Ciclesonide HFA Nasal Aerosol 160 mcg once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older.

Placebodrug

Placebo HFA Nasal Aerosol once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older.