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Azelastine Allergen Chamber - Onset of Action Study

NCT06126952 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-03-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • MEDA Pharma GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Patricia Couroux, Dr. · Cliantha Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-30
Primary Completion
2024-02-23
Completion
2024-03-18

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06126952 on ClinicalTrials.gov