Recruiting
Phase 2

EDS-FLU

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT05275686

Conditions

Eustachian Tube Dysfunction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray

Placebo Nasal Spray

Study Details

Brief summary:

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

Study ID

NCT05275686

Start date

Apr 20, 2022

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Arm 1 (Placebo)

Arm 1 (placebo) will get placebo spray per day.

active comparator: Arm 2 (EDS-FLU)

Arm 2 (EDS-FLU) will get 744 mcg of fluticasone propionate per day.

Interventions

Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray

Patients will use two sprays in each nostril twice a day for 6 weeks and additional 6 weeks (open label).

Placebo Nasal Spray

The Placebo is made of the following ingredients: Purified Water, Microcrystalline Cellulose RC-591, Dextrose, Anhydrous, EDTA Disodium Dihydrate, Benzalkonium Chloride Solution 50%, Polysorbate 80 (Tween 80, HP-LQ-(MH)), Sodium Hydroxide, and Hydrochloric Acid. Patients will use two sprays in each nostril twice a day

Primary outcome measure

  • 7-Item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) [ Time Frame: visit 2 (week 6) ]
  • 7-Item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) [ Time Frame: visit 3 (week 12) ]

Central Contacts and Locations

Central contacts

Missael Vasquez

424-315-2437missael.vasquez@cshs.org

Laura Sarmiento, CCRP

3104234295laura.sarmiento@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Missael Vasquez

424-315-2437missael.vasquez@cshs.org

Laura Sarmiento, CCRP

310-423-4295laura.sarmiento@cshs.org

Principal Investigator:

Arthur Wu, MD

Sacramento Ear, Nose & Throat

Recruiting

Sacramento, California, United States, 95661

Contacts

Rose Khalatyan

916-531-2788rkhalatyan@davinciresearch.net

Randall A Ow, MD

row@sacent.com

Principal Investigator:

Randall A Ow, MD

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Elisa Illing, MD

eilling@iu.edu

Joey Calcagno

jcalcagn@iu.edu

Principal Investigator:

Elisa Illing, MD

Ochsner Health System

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Edward McCoul, MD

edward.mccoul@ochsner.org

Principal Investigator:

Edward McCoul, MD

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

  • Eustachian Tube Dysfunction
  • Fluticasone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2026-03-11.