drugset / Trial / NCT05275686
Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD)
Phase 2
Recruiting
80 enrolled
Cedars-Sinai Medical Center
Indiana University · collabOchsner Health System · collabSacramento Ear, Nose & Throat · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
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).
Timeline
- Start
- 2022-04-20
- Primary completion
- 2027-06-30
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fluticasone propionate | Other / unclassified | 744 ug | Intranasal |