At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 348 enrolled
Drug / intervention
azelastine hydrochloride and fluticasone propionate +1 moredrug
Likely dose
Not stated in 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.
Randomized, Double-Blind Trial of the Safety and Efficacy of Dymista Nasal Spray Compared to Placebo Nasal Spray in the Treatment of Children Ages >4 Years to <12 Years With Seasonal Allergic Rhinitis
In Brief
A Phase 3 clinical trial evaluating azelastine hydrochloride and fluticasone propionate and Dymista vehicle for Seasonal Allergic Rhinitis. Completed, enrolled 348 participants across 31 sites.
Detailed Summary
The purpose of this study is to determine if Dymista nasal spray is better and safer than placebo in treating children ages 4 to \<12 years old who have seasonal allergic rhinitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeasonal Allergic Rhinitis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
First PostedAug 2013
Primary CompletionFeb 2014
TodayJul 2026
First PostedAug 5, 2013
Enrollment StartJul 1, 2013
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.9 years ago
Interventions
azelastine hydrochloride and fluticasone propionatedrug
Dymista vehicledrug