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NCT05275686 · ClinicalTrials.gov registry record · Phase 2
Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD)
A Phase 2 study of Eustachian Tube Dysfunction, sponsored by Cedars-Sinai Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 4
- Study locations
NCT05275686: Recruiting Phase 2 study of Eustachian Tube Dysfunction, sponsored by Cedars-Sinai Medical Center.
NCT05275686 is a Phase 2 study of Eustachian Tube Dysfunction that is actively recruiting participants, run by Cedars-Sinai Medical Center. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05275686, a Phase 2 study of Eustachian Tube Dysfunction, is actively recruiting participants, sponsored by Cedars-Sinai Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 4
- Study locations
Study 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).
Primary Outcome
Eustachian tube dysfunction symptoms measured by the validated quality of life 7-Item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) at visit 2. The scale is from 1 (no problem) to 7 (severe problem).
Conditions Studied
Interventions
- DRUG Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray
- OTHER Placebo Nasal Spray
Study Locations (4)
California
- Cedars-Sinai Medical Center - Los Angeles
- Sacramento Ear, Nose & Throat - Sacramento
Indiana
- Indiana University - Indianapolis
Louisiana
- Ochsner Health System - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-04-20 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT05275686 shows while recruiting
NCT05275686 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Eustachian Tube Dysfunction appearing as the primary indexed condition, and to 2 interventions - of which Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray is the first listed.
NCT05275686 reports a single indexed study location in California, Indiana, Louisiana.
Frequently Asked Questions
What is clinical trial NCT05275686 about?
NCT05275686 is a clinical study titled "Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD)". 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 nasopharyn...
What is the current status of trial NCT05275686?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2022-04-20. Estimated completion is 2027-12-31.
What conditions does trial NCT05275686 study?
This clinical trial studies the following conditions: Eustachian Tube Dysfunction.
What interventions are being tested in trial NCT05275686?
The interventions under investigation include: Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray (DRUG), Placebo Nasal Spray (OTHER).
Who is sponsoring clinical trial NCT05275686?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05275686 being conducted?
This trial has 4 study locations across California, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05275686's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,118 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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