At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 707 enrolled
Drug / intervention
80 mcg Ciclesonide +2 moredrug
Likely dose
80 mcg Ciclesonidefrom 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.
A Randomized, Multicenter, Double Blind, Placebo Controlled, Parallel Group, Phase III 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 80 mcg Ciclesonide, 160 mcg Ciclesonide, and 1 other intervention for Seasonal Allergic Rhinitis. Completed, enrolled 707 participants across 4 sites.
Detailed Summary
To demonstrate the efficacy of ciclesonide HFA applied as a nasal aerosol (160 μg and 80 μg) once daily compared to placebo in subjects with SAR.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeasonal Allergic Rhinitis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2008
First PostedNov 2008
Primary CompletionFeb 2009
TodayJul 2026
First PostedNov 13, 2008
Enrollment StartNov 1, 2008
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 17.6 years ago
Interventions
80 mcg Ciclesonidedrug
80 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril)
160 mcg Ciclesonidedrug
160 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril)
Placebodrug
Placebo HFA Inhaler once daily (one actuation per nostril)