Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD)
Recruiting
Phase 2
Interventional Study
Eustachian Tube Dysfunction
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 80 (estimated)
- Sponsor
- Cedars-Sinai Medical Center · Other
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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 Eu…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age greater than or equal to 18 years old, \<80 years old
* Chronic Eustachian tube dysfunction defined as:
* Symptoms in one or both ears \> 3 months AND
* ETDQ-7 score \>14.5 AND
* Type B, C, or As tympanometry
* Female subjects of childbearing potential must have a n…
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