Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD)

PHASE2RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

April 20, 2022

Primary Completion Date

April 30, 2025

Study Completion Date

December 31, 2025

Conditions
Eustachian Tube Dysfunction
Interventions
DRUG

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).

OTHER

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

Trial Locations (4)

46202

RECRUITING

Indiana University, Indianapolis

70121

RECRUITING

Ochsner Health System, New Orleans

90048

RECRUITING

Cedars-Sinai Medical Center, Los Angeles

95661

RECRUITING

Sacramento Ear, Nose & Throat, Sacramento

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sacramento Ear, Nose & Throat

UNKNOWN

collaborator

Ochsner Health System

OTHER

collaborator

Indiana University

OTHER

lead

Cedars-Sinai Medical Center

OTHER

NCT05275686 - Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD) | Biotech Hunter | Biotech Hunter