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

Description

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 spray delivery system is available now for fluticasone that improves its delivery to the nasopharynx. The hypothesis of this study is that fluticasone using the novel spray system is effective for Eustachian tube dysfunction (ETD).

Conditions

Eustachian Tube Dysfunction

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Study Overview

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Study Details

Study overview

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 spray delivery system is available now for fluticasone that improves its delivery to the nasopharynx. The hypothesis of this study is that fluticasone using the novel spray system is effective for Eustachian tube dysfunction (ETD).

Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD) in a Multi-center, Double-Blinded, Placebo-controlled Trial

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

Condition
Eustachian Tube Dysfunction
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Sacramento

Sacramento Ear, Nose & Throat, Sacramento, California, United States, 95661

Indianapolis

Indiana University, Indianapolis, Indiana, United States, 46202

New Orleans

Ochsner Health System, New Orleans, Louisiana, United States, 70121

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Cedars-Sinai Medical Center,

Arthur Wu, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

2025-01