Eustachian Tube Dysfunction study: Fluticasone Propionate
Official title Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD)
ClinicalTrials.gov ID: NCT05275686
What this study is testing
What is Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray?
This is an investigational nasal spray being studied as a potential treatment for Eustachian tube dysfunction. It is designed to reduce swelling and inflammation in the nasal passages and throat area.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a new nasal spray helps with Eustachian tube dysfunction. It checks if this method works better than usual care.
- Who it's for
- You may be able to join if you have Eustachian tube dysfunction.
- What's involved
- You would use a special nasal spray at home. This spray delivers medicine to the back of your nose.
- Time commitment
- The source text does not say how long the study lasts or what visits are needed.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Age greater than or equal to 18 years old, \<80 years old
- Symptoms in one or both ears \> 3 months AND
- ETDQ-7 score \>14.5 AND
- Type B, C, or As tympanometry
- Female people of childbearing potential must have a negative urine pregnancy test at screening and throughout the study duration.
You likely can't join if
- Age \<18 years old
- Known history of otologic surgery (excluding myringotomy or myringotomy tubes)
- Use of any additional intranasal medication
- Tympanic membrane perforation
- Adhesive otitis media
- Cholesteatoma or significant retraction pocket
See the full eligibility criteria
- Age greater than or equal to 18 years old, \<80 years old
- Symptoms in one or both ears \> 3 months AND
- ETDQ-7 score \>14.5 AND
- Type B, C, or As tympanometry
- Female people of childbearing potential must have a negative urine pregnancy test at screening and throughout the study duration.
- Age \<18 years old
- Known history of otologic surgery (excluding myringotomy or myringotomy tubes)
- Use of any additional intranasal medication
- Tympanic membrane perforation
- Adhesive otitis media
- Cholesteatoma or significant retraction pocket
- Middle ear effusion
- Nasopharyngeal tumor
- Any history of head and neck cancer
- Any history of head and neck irradiation
- Any history of temporomandibular disorder or prior surgery to the temporomandibular joint
- Any medical condition that the investigator deems inappropriate for enrollment
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Sacramento, California, United States
- Indianapolis, Indiana, United States
- New Orleans, Louisiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Sacramento, California, United States; Indianapolis, Indiana, United States; New Orleans, Louisiana, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.