Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD)

Launched by CEDARS-SINAI MEDICAL CENTER · Mar 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to deliver a medication called fluticasone to help people with Eustachian Tube Dysfunction (ETD). ETD is a condition where the tubes that connect the middle ear to the back of the throat do not function properly, leading to symptoms like ear fullness or discomfort. The researchers believe that using a special nasal spray delivery system will provide better treatment for ETD compared to traditional nasal sprays, which have not been proven very effective.

To participate in the trial, you need to be between 18 and 79 years old and have experienced symptoms of ETD for more than three months. You will also need to meet certain medical criteria, like having specific test results related to your ear health. If you decide to join, you will receive the novel nasal spray and will be monitored throughout the study to see how well it works for your condition. This trial is currently looking for volunteers, and it is important to discuss any medical history or conditions with the study team to determine if you qualify.

Gender

ALL

Eligibility 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