NCT06126952

Azelastine Allergen Chamber - Onset of Action Study

Randomized, Double-blind, Cross-over Clinical Trial to Assess Onset of Action and Efficacy of Azelastine Hydrochloride 0.15% Nasal Spray in the Treatment of Allergen-Induced Allergic Rhinitis Symptoms in an Environmental Exposure Unit in Comparison to Placebo and Mometasone Furoate/Olopatadine Hydrochloride Nasal Spray

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (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 and Efficacy of azelastine hydrochloride 0.15% in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Unit (EEU) followed by a single dose and a 3-day treatment at home.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair)	2 sprays per nostril of Azelastine 0.15% twice daily. Total dose of active drug: 1644 mcg azelastine hydrochloride per day
DRUG	Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray	2 sprays per nostril of Placebo twice daily.
DRUG	Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray	2 sprays per nostril of Ryaltris twice daily. Total dose of active drug: 200 mcg mometasone furoate and 4800 mcg olopatadine per day

Timeline

• Start date: 2023-10-30
• Primary completion: 2024-02-23
• Completion: 2024-03-18
• First posted: 2023-11-13
• Last updated: 2024-03-20

Locations

1 site across 1 country: Canada