RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

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

Quick Facts

Study Start:2022-04-20
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05275686

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age greater than or equal to 18 years old, \<80 years old
  2. * Chronic Eustachian tube dysfunction defined as:
  3. * Symptoms in one or both ears \> 3 months AND
  4. * ETDQ-7 score \>14.5 AND
  5. * Type B, C, or As tympanometry
  6. * Female subjects of childbearing potential must have a negative urine pregnancy test at screening and throughout the study duration.
  1. * Age \<18 years old
  2. * Known history of otologic surgery (excluding myringotomy or myringotomy tubes)
  3. * Use of any additional intranasal medication
  4. * Tympanic membrane perforation
  5. * Adhesive otitis media
  6. * Cholesteatoma or significant retraction pocket
  7. * Middle ear effusion
  8. * Nasopharyngeal tumor
  9. * Any history of head and neck cancer
  10. * Any history of head and neck irradiation
  11. * Any history of temporomandibular disorder or prior surgery to the temporomandibular joint
  12. * Any medical condition that the investigator deems inappropriate for enrollment

Contacts and Locations

Study Contact

Missael Vasquez
CONTACT
424-315-2437
missael.vasquez@cshs.org
Laura Sarmiento, CCRP
CONTACT
3104234295
laura.sarmiento@cshs.org

Principal Investigator

Arthur Wu, MD
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Sacramento Ear, Nose & Throat
Sacramento, California, 95661
United States
Indiana University
Indianapolis, Indiana, 46202
United States
Ochsner Health System
New Orleans, Louisiana, 70121
United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-20
Study Completion Date2025-01

Study Record Updates

Study Start Date2022-04-20
Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

  • Eustachian Tube Dysfunction
  • Fluticasone

Additional Relevant MeSH Terms

  • Eustachian Tube Dysfunction