NCT04652245

Dymista Allergen Chamber - Onset of Action Study

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: MEDA Pharma GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 3	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
DRUG	Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 5	Single dose, one spray in each nostril of Placebo nasal spray at Visit 5
DRUG	Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate 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
DRUG	Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 3	Single dose, one spray in each nostril of Placebo nasal spray, at Visit 3

Timeline

• Start date: 2020-12-14
• Primary completion: 2021-12-04
• Completion: 2021-12-13
• First posted: 2020-12-03
• Last updated: 2023-03-23
• Results posted: 2023-03-23

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study