Actively Recruiting
Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD) in a Multi-center, Double-Blinded, Placebo-controlled Trial
Led by Cedars-Sinai Medical Center · Updated on 2026-03-11
80
Participants Needed
4
Research Sites
26 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
Researchers are evaluating the effect of a new nasal spray delivery system for fluticasone on people with chronic Eustachian tube dysfunction (ETD), a condition that can occur with or without other nasal or sinus issues. This study addresses the lack of strong evidence supporting the use of nasal steroid sprays for ETD, despite their common use. The new delivery system aims to improve medication reach to the nasopharynx, where the Eustachian tubes are located, possibly improving treatment outcomes. The trial compares a placebo spray with the fluticasone exhalational delivery system (EDS-FLU). Participants in the active group will use two sprays in each nostril twice daily, delivering 744 mcg of fluticasone propionate per day, for a total of 12 weeks including an open-label phase. The placebo group receives a similar spray without the active drug. The delivery method involves users exhaling into the device to direct the spray deeper into the nasal passages and nasopharynx. Participants will be involved in regular visits to assess their symptoms using the 7-Item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) at 6 and 12 weeks. The study includes monitoring of ear function through tympanometry and tracking safety and adherence. The total participation spans at least 12 weeks, with follow-up evaluations focused on symptom improvement and treatment impact.
CONDITIONS
Brief 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 greater than or equal to 18 years old and less than 80 years old
- Chronic Eustachian tube dysfunction with symptoms in one or both ears lasting more than 3 months
- Eustachian Tube Dysfunction Questionnaire (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 less than 18 years old
- 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 surgery to the temporomandibular joint
- Any medical condition deemed inappropriate for enrollment by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants use the assigned nasal spray (either the active fluticasone spray or placebo) with two sprays in each nostril twice a day.
Visits at baseline and Week 6
Duration - Additional 6 weeks
Participants continue using the fluticasone nasal spray in an open-label phase following the initial treatment period.
Visit at Week 12
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
L
Laura Sarmiento, CCRP
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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