Status:
RECRUITING
Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD)
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
Sacramento Ear, Nose & Throat
Ochsner Health System
Conditions:
Eustachian Tube Dysfunction
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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...
Detailed Description
BACKGROUND AND RATIONALE Eustachian tube dysfunction (ETD) can be a symptom of allergic rhinitis, non-allergic rhinitis, or chronic rhinosinusitis. However, it can also be a separate entity with pati...
Eligibility Criteria
Inclusion
- Age greater than or equal to 18 years old, \<80 years old
- Chronic Eustachian tube dysfunction defined as:
- Symptoms in one or both ears \> 3 months AND
- ETDQ-7 score \>14.5 AND
- Type B, C, or As tympanometry
- Female subjects of childbearing potential must have a negative urine pregnancy test at screening and throughout the study duration.
Exclusion
- Age \<18 years old
- Known history of otologic 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
- Any history of head and neck cancer
- Any history of head and neck irradiation
- Any history of temporomandibular disorder or prior surgery to the temporomandibular joint
- Any medical condition that the investigator deems inappropriate for enrollment
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05275686
Start Date
April 20 2022
End Date
December 1 2025
Last Update
February 12 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Sacramento Ear, Nose & Throat
Sacramento, California, United States, 95661
3
Indiana University
Indianapolis, Indiana, United States, 46202
4
Ochsner Health System
New Orleans, Louisiana, United States, 70121