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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT05275686
Phase
PHASE2
Status
Recruiting
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Conditions

  • Eustachian Tube Dysfunction

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • 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).
  • 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

Study Details

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).

Key Dates

Start date
Apr 20, 2022
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Missael Vasquez
[email protected]
424-315-2437
Laura Sarmiento, CCRP
[email protected]
310-423-4295
Arthur Wu, MD (PRINCIPAL_INVESTIGATOR)
Sacramento Ear, Nose & ThroatSacramentoCalifornia95661
Rose Khalatyan
[email protected]
916-531-2788
Randall A Ow, MD
[email protected]
Randall A Ow, MD (PRINCIPAL_INVESTIGATOR)
Indiana UniversityIndianapolisIndiana46202
Elisa Illing, MD
[email protected]
Joey Calcagno
[email protected]
Elisa Illing, MD (PRINCIPAL_INVESTIGATOR)
Ochsner Health SystemNew OrleansLouisiana70121
Edward McCoul, MD
[email protected]
Edward McCoul, MD (PRINCIPAL_INVESTIGATOR)

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Cedars-Sinai Medical Center· Los Angeles, CASacramento Ear, Nose & Throat· Sacramento, CAIndiana University· Indianapolis, INOchsner Health System· New Orleans, LA

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