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RecruitingAccepts healthy volunteersPhase 2

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

Cedars-Sinai Medical Center · with Sacramento Ear, Nose & Throat, Ochsner Health System · NCT05275686

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–80 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 2
Target enrollment
80
US sites recruiting
4
Study start
April 20, 2022
Record last updated
March 11, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray; Placebo Nasal Spray

Conditions: Eustachian Tube Dysfunction

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Cedars-Sinai Medical Center

    Los Angeles, CA 90048

    Site contact: Missael Vasquez · 424-315-2437 · missael.vasquez@cshs.org

  • Sacramento Ear, Nose & Throat

    Sacramento, CA 95661

    Site contact: Rose Khalatyan · 916-531-2788 · rkhalatyan@davinciresearch.net

  • Indiana University

    Indianapolis, IN 46202

    Site contact: Elisa Illing, MD · eilling@iu.edu

  • Ochsner Health System

    New Orleans, LA 70121

    Site contact: Edward McCoul, MD · edward.mccoul@ochsner.org

Study contacts (from the official record)

  • Missael Vasquez · 424-315-2437 · missael.vasquez@cshs.org
  • Laura Sarmiento, CCRP · 3104234295 · laura.sarmiento@cshs.org
All healthy volunteers studies in California →
Effect of Novel Exhalational Delivery System With Fluticasone… (NCT05275686) | Bored Studies