At a glance
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Clinical Trial to Assess Onset of Action of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray Delivered in a Single Spray (Dymista) in the Treatment of Allergen-Induced Allergic Rhinitis Symptoms in Comparison to Placebo in an Environmental Exposure Unit (EEU)
In Brief
A Phase 4 clinical trial evaluating Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 3, Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 5, and 2 other interventions for Seasonal Allergic Rhinitis. Completed, enrolled 216 participants across 1 site.
Detailed Summary
This study is to assess the onset of action of fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray (Dymista) in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Unit (EEU).
Study Details
Timeline
Interventions
Single dose, one spray in each nostril of Dymista nasal spray, approximately 137 μg of azelastine hydrochloride and 50 μg of fluticasone propionate per actuation, at Visit 3
Single dose, one spray in each nostril of Placebo nasal spray at Visit 5
Single dose, one spray in each nostril of Dymista nasal spray, approximately 137 μg of azelastine hydrochloride and 50 μg of fluticasone propionate per actuation, at Visit 5
Single dose, one spray in each nostril of Placebo nasal spray, at Visit 3