CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 310 enrolled
Drug / intervention
Ciclesonide HFA Nasal Aerosol 320 mcg +6 moredrug
Likely dose
Ciclesonide HFA Nasal Aerosol 320 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/NCT01033825
NCT01033825Phase 3Completed
CompareCT.gov

A 6-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety and Efficacy Study of the Potential Inhibitory Effects on the Hypothalamic-Pituitary-Adrenal Axis of Ciclesonide HFA Nasal Aerosol and Ciclesonide Aqueous Nasal Spray in Subjects 12 Years and Older With Perennial Allergic Rhinitis

Sumitomo Pharma America, Inc.·interventional·Posted Dec 17, 2009·Updated Jul 19, 2012

In Brief

A Phase 3 clinical trial evaluating Ciclesonide HFA Nasal Aerosol 320 mcg, Ciclesonide HFA Nasal Aerosol 160 mcg, and 5 other interventions for Perennial Allergic Rhinitis. Completed, enrolled 310 participants across 6 sites.

Detailed Summary

To demonstrate the effects of ciclesonide applied as a nasal aerosol and ciclesonide aqueous (AQ) nasal spray on hypothalamic-pituitary-adrenal axis.

Study Details

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

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 17, 2009
Enrollment StartJan 1, 2010
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 16.5 years ago

Interventions

Ciclesonide HFA Nasal Aerosol 320 mcgdrug

Ciclesonide HFA Nasal Aerosol 320 μg once daily

Ciclesonide HFA Nasal Aerosol 160 mcgdrug

Ciclesonide HFA Nasal Aerosol 160 μg once daily

HFA Nasal Aerosol placebodrug

HFA Nasal Aerosol placebo once daily

Ciclesonide Aqueous Nasal Spray 200 mcgdrug

Ciclesonide Aqueous Nasal Spray 200 mcg once daily

AQ Nasal Spray Placebodrug

AQ Nasal Spray Placebo once daily

Placebo plus Dexamethasone HFAdrug

Dexamethasone capsules 6 mg once daily

Placebo AQ plus Dexamethasone 6 mgdrug

Placebo AQ plus Dexamethasone 6 mcg capsules once daily