At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 191 enrolled
Drug / intervention
205.5 mcg of azelastine hydrochloride +1 moredrug
Likely dose
205.5 mcg of azelastine hydrochloridefrom 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 Trial of the Safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray in Children Ages >6 Months to <6 Years With Allergic Rhinitis
In Brief
A Phase 4 clinical trial evaluating 205.5 mcg of azelastine hydrochloride and 137 mcg of azelastine hydrochloride for Allergic Rhinitis. Completed, enrolled 191 participants across 14 sites.
Detailed Summary
The purpose of this study is to compare the safety of 2 different doses of the investigational use of an allergy medication (Astepro Nasal Spray) in the treatment of allergic rhinitis (AR). This is an open-label study; that is, parent and child will know which group each is in.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Rhinitis
CountriesUnited States
CollaboratorsNovella Clinical
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJun 2013
First PostedJun 2013
Primary CompletionApr 2014
Study CompletionAug 2014
TodayJul 2026
First PostedJun 19, 2013
Enrollment StartJun 1, 2013
Primary CompletionApr 1, 2014
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.0 years ago
Interventions
205.5 mcg of azelastine hydrochloridedrug
nasal spray
137 mcg of azelastine hydrochloridedrug
nasal spray