Study of a New Fluticasone Nasal Spray Delivery System for Treating Eustachian Tube Dysfunction in Adults

What this Trial Is About

Researchers are evaluating the effect of a new nasal spray delivery system for fluticasone on people with chronic Eustachian tube dysfunction ETD, a condition that can occur with or without other nasal or sinus issues. This study addresses the lack of strong evidence supporting the use of nasal steroid sprays for ETD, despite their common use. The new delivery system aims to improve medication reach to the nasopharynx, where the Eustachian tubes are located, possibly improving treatment outcomes. The trial compares a placebo spray with the fluticasone exhalational delivery system EDS-FLU. Participants in the active group will use two sprays in each nostril twice daily, delivering 744 mcg of fluticasone propionate per day, for a total of 12 weeks including an open-label phase. The placebo group receives a similar spray without the active drug. The delivery method involves users exhaling into the device to direct the spray deeper into the nasal passages and nasopharynx. Participants will be involved in regular visits to assess their symptoms using the 7-Item Eustachian Tube Dysfunction Questionnaire ETDQ-7 at 6 and 12 weeks. The study includes monitoring of ear function through tympanometry and tracking safety and adherence. The total participation spans at least 12 weeks, with follow-up evaluations focused on symptom improvement and treatment impact.

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