New nasal spray delivery system for treating Eustachian tube dysfunction
Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD) in a Multi-center, Double-Blinded, Placebo-controlled Trial
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 |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 4 sites (Los Angeles, California and 3 other locations) |
| Trial ID | NCT05275686 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with chronic Eustachian tube dysfunction symptoms lasting over three months.
Not a fit: Patients with a history of otologic surgery, tympanic membrane perforation, or other significant ear conditions may not benefit from this study.
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 performed: While there is limited evidence supporting the use of nasal sprays for ETD, this novel approach has not been extensively tested in prior studies.
Eligibility criteria
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 this trial is running
Los Angeles, California and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.