Actively Recruiting
Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD)
Led by Cedars-Sinai Medical Center · Updated on 2026-03-11
80
Participants Needed
4
Research Sites
297 weeks
Total Duration
On this page
Sponsors
C
Cedars-Sinai Medical Center
Lead Sponsor
S
Sacramento Ear, Nose & Throat
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and younger than 80 years
- Chronic Eustachian tube dysfunction with symptoms in one or both ears lasting more than 3 months
- ETDQ-7 score greater than 14.5
- Type B, C, or As tympanometry
- Female participants of childbearing potential must have a negative urine pregnancy test at screening and throughout the study
You will not qualify if you...
- Age younger than 18 years
- History of ear surgery excluding myringotomy or myringotomy tubes
- Use of any additional intranasal medication
- Tympanic membrane perforation
- Adhesive otitis media
- Cholesteatoma or significant retraction pocket
- Middle ear effusion
- Nasopharyngeal tumor
- History of head and neck cancer
- History of head and neck irradiation
- History of temporomandibular disorder or prior temporomandibular joint surgery
- Any medical condition deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Sacramento Ear, Nose & Throat
Sacramento, California, United States, 95661
Actively Recruiting
3
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
4
Ochsner Health System
New Orleans, Louisiana, United States, 70121
Actively Recruiting
Research Team
M
Missael Vasquez
CONTACT
L
Laura Sarmiento, CCRP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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