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Corticosteroid

Fluticasone Nasal Spray for Eustachian Tube Dysfunction

Phase 2
Recruiting
Led By Arthur Wu, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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, ETDQ-7 score >14.5, Type B, C, or As tympanometry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 3 (week 12)
Awards & highlights

Study Summary

This trial found that fluticasone delivered via a novel spray system is effective in treating Eustachian tube dysfunction.

Who is the study for?
Adults aged 18-79 with chronic Eustachian tube dysfunction, experiencing symptoms for over 3 months and specific tympanometry types. Women of childbearing age must test negative for pregnancy. Excluded are those with ear drum perforation, middle ear issues, nasopharyngeal tumors, head and neck cancer or radiation history, TMJ disorders or surgery, other nasal treatments, and certain ear surgeries.Check my eligibility
What is being tested?
The trial is testing a new way to deliver Fluticasone (a steroid spray) directly to the nasopharynx against a placebo. The goal is to see if this method is more effective in treating Eustachian tube dysfunction than current treatments.See study design
What are the potential side effects?
Fluticasone may cause nosebleeds, headaches, sore throat or nose irritation. Long-term use can sometimes lead to changes in voice or signs of infection due to immune suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 79 years old.
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I have had ear problems for more than 3 months and a specific test score above 14.5.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 3 (week 12)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 3 (week 12) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
7-Item Eustachian Tube Dysfunction Questionnaire (ETDQ-7)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Arm 2 (EDS-FLU)Active Control1 Intervention
Arm 2 (EDS-FLU) will get 744 mcg of fluticasone propionate per day.
Group II: Arm 1 (Placebo)Placebo Group1 Intervention
Arm 1 (placebo) will get placebo spray per day.

Find a Location

Who is running the clinical trial?

Indiana UniversityOTHER
991 Previous Clinical Trials
1,094,867 Total Patients Enrolled
Cedars-Sinai Medical CenterLead Sponsor
502 Previous Clinical Trials
165,613 Total Patients Enrolled
Sacramento Ear, Nose & ThroatUNKNOWN

Media Library

Fluticasone Propionate (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05275686 — Phase 2
Eustachian Tube Dysfunction Research Study Groups: Arm 1 (Placebo), Arm 2 (EDS-FLU)
Eustachian Tube Dysfunction Clinical Trial 2023: Fluticasone Propionate Highlights & Side Effects. Trial Name: NCT05275686 — Phase 2
Fluticasone Propionate (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05275686 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How extensive is the participant pool for this clinical trial?

"Indeed, information on clinicaltrials.gov affirms that this research is actively recruiting participants; it was first posted on April 20th 2022 and most recently updated on August 24th 2022. The aim of the trial is to recruit 80 individuals from two different medical centres."

Answered by AI

Is the EDS-FLU arm of the clinical trial safe for participants?

"A score of 2 was attributed to Arm 2 (EDS-FLU) on the safety scale as clinical evidence supports its security but there is no data regarding its efficacy."

Answered by AI

Is there a current need for volunteers to participate in this investigation?

"Affirmative; clinicaltrials.gov lists this medical trial as actively recruiting participants, having been initially published on April 20th 2022 and recently updated on August 24th 2022. The study requires 80 patients to be recruited from 2 distinct sites."

Answered by AI

Does the selection criteria for this trial extend to persons aged 35 and over?

"Per the inclusion parameters of this medical research, prospective participants must be between 18 and 80 years old."

Answered by AI

Who fulfills the criteria for enrollment in this experiment?

"This medical study is actively looking for 80 individuals between the ages of 18 and 80 with eustachian tube dysfunction (ETD). In addition to age eligibility, participants must have experienced symptoms in either one or both ears lasting at least 3 months. Furthermore, they will be required to score above 14.5 on an ETDQ-7 evaluation as well as present a Type B, C, or As tympanometry reading. Lastly, female subjects of childbearing potential are mandated to take a urine pregnancy test prior to enrollment and throughout the course of the trial's duration."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD)
Arthur Wu 2022. "Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05275686.
~17 spots leftby Jan 2025
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