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

RecruitingPhase 2Ages 18 Years - 80 YearsAllCedars-Sinai Medical Center
NCT05275686 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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
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What it tests

  • Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray
  • Placebo Nasal Spray
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Where

4 sites
Cedars-Sinai Medical Center
Los Angeles, United States
Sacramento Ear, Nose & Throat
Sacramento, United States
Indiana University
Indianapolis, United States
Ochsner Health System
New Orleans, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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