Azelastine + Fluticasone Nasal Spray for Hay Fever

Recruiting in Palo Alto (17 mi)

Overseen byDarin Brimhall, DO, FACP

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Teva Pharmaceuticals USA

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

To evaluate the therapeutic equivalence of a test formulation of Azelastine hydrochloride and Fluticasone propionate Nasal Spray to the reference listed drug, Dymista™ Nasal Spray in the relief of the signs and symptoms of Seasonal Allergic Rhinitis.

Research Team

Darin Brimhall, DO, FACP

Principal Investigator

Novum Pharmaceutical Research Services

Eligibility Criteria

This trial is for individuals aged 12 or older with a documented positive skin test to seasonal allergens and at least two years of history with Seasonal Allergic Rhinitis. They must have specific minimum symptom scores for nasal congestion and ocular issues. Excluded are pregnant women, those on certain medications, patients with recent infections or surgeries, heavy smokers, and anyone with chronic conditions that could interfere.

Inclusion Criteria

I (or my guardian if I'm under 18) have signed the informed consent form.

You have had a positive allergy skin test to the allergens that are in season during the study.

I have had seasonal allergies for at least two years.

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Exclusion Criteria

You have not had allergies to pollen or other allergens for at least 2 years before the study starts.

I am younger than 12 years old.

I have seasonal allergies, not year-round allergies.

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Treatment Details

Interventions

Azelastine hydrochloride and Fluticasone propionate (Antihistamine and Corticosteroid Combination)
Dymista™ (Antihistamine and Corticosteroid Combination)

Trial OverviewThe study aims to compare the effectiveness of a new combination nasal spray (Azelastine hydrochloride and Fluticasone propionate) against Dymista™ in treating symptoms of Seasonal Allergic Rhinitis. Participants will also be compared to a placebo group to measure the treatment's impact on nasal congestion and related symptoms.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Investigational Test ProductExperimental Treatment1 Intervention

Azelastine hydrochloride and Fluticasone propionate Nasal Spray, 137/50 mcg

Group II: Reference Listed DrugActive Control1 Intervention

Dymista™ (azelastine hydrochloride/fluticasone propionate) Nasal Spray, 137/50 mcg

Group III: PlaceboPlacebo Group1 Intervention

Placebo Nasal Spray