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Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD)
Sponsor: Cedars-Sinai Medical Center
Summary
Intranasal nasal steroid sprays are the mainstay of treatment for chronic Eustachian tube dysfunction despite having little supportive evidence in the literature. A novel, commercially available nasal spray delivery system is available now for fluticasone that improves its delivery to the nasopharynx. The hypothesis of this study is that fluticasone using the novel spray system is effective for Eustachian tube dysfunction (ETD).
Official title: Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD) in a Multi-center, Double-Blinded, Placebo-controlled Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2022-04-20
Completion Date
2027-12-31
Last Updated
2026-03-11
Healthy Volunteers
Yes
Conditions
Interventions
Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray
Patients will use two sprays in each nostril twice a day for 6 weeks and additional 6 weeks (open label).
Placebo Nasal Spray
The Placebo is made of the following ingredients: Purified Water, Microcrystalline Cellulose RC-591, Dextrose, Anhydrous, EDTA Disodium Dihydrate, Benzalkonium Chloride Solution 50%, Polysorbate 80 (Tween 80, HP-LQ-(MH)), Sodium Hydroxide, and Hydrochloric Acid. Patients will use two sprays in each nostril twice a day
Locations (4)
Cedars-Sinai Medical Center
Los Angeles, California, United States
Sacramento Ear, Nose & Throat
Sacramento, California, United States
Indiana University
Indianapolis, Indiana, United States
Ochsner Health System
New Orleans, Louisiana, United States