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).
Age greater than or equal to 18 years old, <80 years old
Symptoms in one or both ears > 3 months AND
ETDQ-7 score >14.5 AND
Type B, C, or As tympanometry
Age <18 years old
Known history of otologic surgery (excluding myringotomy or myringotomy tubes)
Use of any additional intranasal medication
Tympanic membrane perforation
Parallel
Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray
DrugPatients will use two sprays in each nostril twice a day for 6 weeks and additional 6 weeks (open label).
Placebo Nasal Spray
Other interventionThe 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
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).
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).
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Cedars-Sinai Medical Center
Lead sponsor
Sacramento Ear, Nose & Throat
Collaborator
Ochsner Health System
Collaborator
Indiana University
Collaborator
