At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Clinical Trial to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol (160 μg Once Daily and 80 μg Once Daily) for the Treatment of Seasonal Allergic Rhinitis (SAR) to Mountain Cedar in Subjects 12 Years and Older
In Brief
A Phase 3 clinical trial evaluating Ciclesonide HFA 160 μg, Ciclesonide HFA 80 μg, and 1 other intervention for Seasonal Allergic Rhinitis. Completed, enrolled 671 participants across 7 sites.
Detailed Summary
This clinical research study will evaluate the safety and effectiveness of two doses of an investigational medication (ciclesonide nasal aerosol) for the treatment of subjects with of seasonal allergic rhinitis (SAR). The study will consist of a Screening Period to confirm study eligibility, followed by a Single-Blind Placebo Run-in period to acclimate subjects to the proper use of the study medication and to assess the subject's severity of SAR symptoms, followed by a 2-week double-blind treatment period to assess the safety and effectiveness of the study medication when given to eligible subjects.
Study Details
Timeline
Interventions
Ciclesonide HFA Nasal Aerosol 160 μg once daily
Ciclesonide HFA Nasal Aerosol 80 μg once daily
Placebo HFA Nasal Aerosol once daily