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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 to 4 hours post application

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

Do I qualify?Apply below to find out

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of individuals is this trial best suited for?

"The present medical trial is seeking 84 patients with hay fever aged between 18 and 55 to join. Those interested must meet both of these criteria in order to be accepted."

Answered by AI

Is this experiment recruiting those aged 55 and beyond?

"This clinical study is open to patients aged 18-55. There are 21 additional trials available for minors and 46 more reserved for adults over the age of 65."

Answered by AI

How many volunteers have enlisted in the research initiative?

"Affirmative. Clinicaltrials.gov shows that recruitment for this trial began on October 30th 2023 and was brought up to date on November 6th 2023. The research team is looking to acquire 84 participants from just one clinical site."

Answered by AI

Is the recruitment process for this trial still open?

"Affirmative. At present, data from clinicaltrials.gov outlines that this research trial is actively enrolling patients. It was initially made available on October 30th 2023 and the most recent updates were shared on November 6th 2023. This study requires 84 participants to be recruited from a single site."

Answered by AI

What sort of safety profile does Azelastine hydrochloride 0.15% nasal spray (Azelair) have for patients?

"Since Azelair is a Phase 2 treatment, our team assessed its safety as a score of two; there are data pointing to the medication's safety but none arguing for efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Azelastine Allergen Chamber - Onset of Action Study

2023. "Azelastine Allergen Chamber - Onset of Action Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06126952.