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

StatusRecruiting
PhasePhase 2
Started2022-04-20
View on ClinicalTrials.gov ↗

Amendment history

2026-03-09
Study Status v8
Primary completion date2025-04→2027-06-30
Completion date2025-12→2027-12-31
2025-02-10
Study Status v7
Primary completion date2025-01→2025-04
Completion date2025-01→2025-12
2024-03-13
Study Status, Sponsor/Collaborators, Contacts/Locations v6
Primary completion date2024-03→2025-01
Completion date2024-03→2025-01
Study sites3→4
Collaborators2 to 3 entries
Indiana University
2023-03-06
Study Status v5
Primary completion date2023-12→2024-03
Completion date2023-12→2024-03
2022-12-15
Study Status, Sponsor/Collaborators, Contacts/Locations v4
Study sites2→3
Collaborators1 to 2 entries
Ochsner Health System
Show 3 earlier versions
2022-08-24
Study Status, Sponsor/Collaborators, Contacts/Locations v3
Primary completion date2023-04→2023-12
Completion date2023-04→2023-12
Study sites1→2
Collaborators+29 characters
Sacramento Ear, Nose & Throat
2022-05-18
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2023-03→2023-04
Completion date2023-03→2023-04
Start dateestimated 2022-03→confirmed 2022-04-20
Study sitesdetails revised at 1 of 1 site
2022-03-10
Study Status, Study Design v1
Re-verified, no change to tracked fields
2022-03-08
Original filing
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).
Trial Details
NCT Number NCT05275686
Lead Sponsor Cedars-Sinai Medical Center
Collaborators: Sacramento Ear, Nose & Throat, Ochsner Health System, Indiana University
Conditions Eustachian Tube Dysfunction
Enrollment 80 participants
Start Date 2022-04-20
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-11