New nasal spray delivery system for treating Eustachian tube dysfunction
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
Run by Cedars-Sinai Medical Center · NCT05275686 · Data updated 2026-11-12
This study tests a new nasal spray to see if it can help people with Eustachian tube dysfunction feel better by delivering medication more effectively.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 4 sites (Los Angeles, California and 3 other locations) |
| Status | Recruiting |
| Started | April 20, 2022 |
| Main results expected | June 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | March 11, 2026 |
| Trial ID | NCT05275686 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 80 with chronic Eustachian tube dysfunction symptoms lasting over three months.
✕Probably not a fit
Patients with a history of otologic surgery, tympanic membrane perforation, or other significant ear conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of a novel exhalational delivery system for fluticasone in treating chronic Eustachian tube dysfunction (ETD). The study involves administering fluticasone via a specialized nasal spray to improve medication delivery to the nasopharynx. Participants will be monitored for symptom improvement and changes in tympanometry results. The trial aims to provide better treatment options for patients suffering from ETD, which currently lacks FDA-approved medications.
Why it matters
Potential benefit: If successful, this study could offer a more effective treatment option for patients with chronic Eustachian tube dysfunction.
How similar studies have gone: While there is limited evidence supporting the use of nasal sprays for ETD, this novel approach has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
-
Cedars-Sinai Medical Center
Los Angeles, California, United States Recruiting -
Sacramento Ear, Nose & Throat
Sacramento, California, United States Recruiting -
Indiana University
Indianapolis, Indiana, United States Recruiting -
Ochsner Health System
New Orleans, Louisiana, United States Recruiting
Study contacts
- Principal investigator: Arthur Wu, MD — Cedars-Sinai Medical Center
- Study coordinator: Missael Vasquez
- Email: missael.vasquez@cshs.org
- Phone: 424-315-2437
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Nasal Dilator Therapy for Patulous Eustachian Tube
This study tests whether wearing a nasal dilator helps reduce symptoms in adults with patulous Eustachian tube dysfunction.
-
Buteyko breathing plus smoking-hygiene for adolescents with passive household smoke exposure and chronic Eustachian tube dysfunction
This project will test whether adding regular Buteyko breathing exercises to smoking-hygiene education helps adolescents exposed to household tobacco smoke who have chronic Eustachian tube dysfunction and reduced lung function.
-
Buteyko breathing for seniors with chronic obstructive Eustachian tube dysfunction
This trial will try adding daily Buteyko breathing exercises to usual care to see if it helps seniors with chronic Eustachian tube dysfunction.
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Balloon dilation procedure for treating Eustachian tube dysfunction
This study is testing if a balloon dilation procedure can help people with Eustachian tube dysfunction feel better compared to a fake treatment.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.