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Antihistamine

Azelastine Nasal Spray for Seasonal Allergic Rhinitis

Phase 2
Waitlist Available
Led By Patricia Couroux, Dr.
Research Sponsored by MEDA Pharma GmbH & Co. KG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 to 4 hours post application
Awards & highlights

Study Summary

This trial studies the effectiveness of azeslstine 0.15% in treating nasal symptoms of SAR caused by allergen exposure in an Environmental Exposure Unit.

Who is the study for?
This trial is for adults aged 18-55 with a history of seasonal allergic rhinitis due to ragweed pollen, confirmed by a skin prick test. It's not for those with asthma, severe allergies to the study drugs, or certain chronic diseases. Women must not be pregnant and should use contraception.Check my eligibility
What is being tested?
The study tests azelastine hydrochloride nasal spray's effectiveness in treating hay fever symptoms after exposure to allergens in a controlled environment and at home. It compares this treatment against Ryaltris (active control) and a placebo.See study design
What are the potential side effects?
Possible side effects include nosebleeds, headache, bitter taste in the mouth, drowsiness or fatigue. Since it involves nasal sprays, some might experience irritation or discomfort in their nose.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 to 4 hours post application
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 4 hours post application for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in TNSS at each post-dose assessment time point (0 to 4 hours after a single dose).
Secondary outcome measures
Change from baseline in individual symptom scores at each post-dose assessment time point (0 to 4 hours after a single dose) at Visits 3, 6, and 9.
Change from baseline in individual symptom scores for all assessment time-points together.
Changes from baseline in T7SS at each post-dose assessment time point (0 to 4 hours after a single dose) at Visits 3, 6, and 9.
+5 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Treatment C (Ryaltris)+Treatment B (Placebo)+Treatment A (Azelair), min. 14 days of wash-out periodExperimental Treatment3 Interventions
Cross-over design
Group II: Treatment C (Ryaltris)+Treatment A (Azelair)+Treatment B (Placebo), min. 14 days of wash-out periodExperimental Treatment3 Interventions
Cross-over design
Group III: Treatment B (Placebo)+Treatment C (Ryaltris)+Treatment A (Azelair), min. 14 days of wash-out periodExperimental Treatment3 Interventions
Cross-over design
Group IV: Treatment B (Placebo)+Treatment A (Azelair)+Treatment C (Ryaltris), min.14 days of wash-out periodExperimental Treatment3 Interventions
Cross-over design
Group V: Treatment A (Azelair)+Treatment C (Ryaltris)+Treatment B (Placebo), min. 14 days of wash-out periodExperimental Treatment3 Interventions
Cross-over design
Group VI: Treatment A (Azelair)+Treatment B (Placebo)+Treatment C (Ryaltris), min. 14 days wash-out periodExperimental Treatment3 Interventions
Cross-over design
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray
2023
Completed Phase 2
~90
Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair)
2023
Completed Phase 2
~90
Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray
2023
Completed Phase 2
~90

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Who is running the clinical trial?

MEDA Pharma GmbH & Co. KGLead Sponsor
29 Previous Clinical Trials
8,082 Total Patients Enrolled
Patricia Couroux, Dr.Principal InvestigatorCliantha Research
~53 spots leftby Jun 2025
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