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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCedars-Sinai Medical Center

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

Age <18 years old

Known history of otologic surgery (excluding myringotomy or myringotomy tubes)

Use of any additional intranasal medication

Tympanic membrane perforation

Trial design

Treatments tested in this trial

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

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Cedars-Sinai Medical Center

Lead sponsor

Sacramento Ear, Nose & Throat

Collaborator

Ochsner Health System

Collaborator

Indiana University

Collaborator