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

NCT05275686 | Recruiting Phase 2 FDA Drug

• 1 other identifier: IIT-WU-2021-EuPEN
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

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

Keywords

Eustachian Tube Dysfunction; Fluticasone

Outcome Measures

Primary Outcomes (2)

• 7-Item Eustachian Tube Dysfunction Questionnaire (ETDQ-7)

  Eustachian tube dysfunction symptoms measured by the validated quality of life 7-Item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) at visit 2. The scale is from 1 (no problem) to 7 (severe problem).

  visit 2 (week 6)

• 7-Item Eustachian Tube Dysfunction Questionnaire (ETDQ-7)

  Eustachian tube dysfunction symptoms measured by the validated quality of life 7-Item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) at visit 3. The scale is from 1 (no problem) to 7 (severe problem).

  visit 3 (week 12)

Study Arms (2)

Arm 1 (Placebo)

PLACEBO COMPARATOR

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

Other: Placebo Nasal Spray

Arm 2 (EDS-FLU)

ACTIVE COMPARATOR

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

Drug: Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray

Interventions

Placebo Nasal Spray OTHER

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

Arm 1 (Placebo)

Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray DRUG

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

Arm 2 (EDS-FLU)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: collaborator
• Cedars-Sinai Medical Center: lead
• Sacramento Ear, Nose & Throat: collaborator
• Ochsner Health System: collaborator

Study Sites (4)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Sacramento Ear, Nose & Throat

Sacramento, California, 95661, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Ochsner Health System

New Orleans, Louisiana, 70121, United States

RECRUITING

MeSH Terms

Interventions

Fluticasone

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Arthur Wu, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Missael Vasquez

CONTACT

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

Laura Sarmiento, CCRP

CONTACT

3104234295; laura.sarmiento@cshs.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients and investigators will be kept blinded until the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Model Details: * Group 1 will get the EDS-FLU nasal spray and use at its normal twice a day dosing. * Group 2 will get the placebo nasal spray in an identical spray canister and use it twice a day. Patients will be randomized to receive placebo in the novel exhalation delivery system versus fluticasone in the device. Patients will take the spray twice daily for six weeks and then return for evaluation. An open label extension will be planned for both groups (placebo, non-placebo) at the end of the six weeks to use the EDS-FLU for an additional six weeks.

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 11, 2022
• Study Start: April 20, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (4)