What is the mechanism of action of this treatment?

The most common treatments for Eustachian Tube Dysfunction (ETD) include intranasal corticosteroids like fluticasone. These corticosteroids work by reducing inflammation in the nasal passages and Eustachian tubes, which helps to alleviate the blockage and improve ventilation of the middle ear. This is crucial for ETD patients as inflammation and swelling can prevent the Eustachian tubes from opening properly, leading to symptoms such as ear fullness, pain, and hearing difficulties. By reducing inflammation, corticosteroids help restore normal function and relieve these symptoms.

What side effects are associated with this type of intervention?

The most common treatment for Eustachian Tube Dysfunction (ETD) involves the use of intranasal corticosteroid sprays like fluticasone. Known side effects of these treatments include nasal irritation, dryness, nosebleeds, and, less commonly, headaches. Long-term use may lead to more serious side effects such as increased intraocular pressure or cataract formation. It is important to use these medications under the guidance of a healthcare provider to minimize risks.

What prior FDA approvals exist?

Intranasal corticosteroid sprays, such as fluticasone, are commonly used for the treatment of Eustachian Tube Dysfunction (ETD). While the context does not specify FDA approvals for ETD, it mentions that intranasal steroid sprays are a mainstay of treatment despite limited supportive evidence. A novel delivery system for fluticasone has been hypothesized to improve its efficacy for ETD by enhancing delivery to the nasopharynx. This suggests that while fluticasone and similar corticosteroids are used, their specific FDA approval status for ETD may not be well-documented.

What other types of research exist?

Currently, there are no specific novel alternatives to Fluticasone mentioned for Eustachian Tube Dysfunction in the provided context. However, treatments such as intranasal betamethasone valerate aerosol and nasal mometasone furoate monohydrate have shown efficacy in related conditions like otitis media with effusion and could be considered as potential alternatives. Consulting with a healthcare provider for the most up-to-date and personalized treatment options is recommended.

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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

Must not have

Use of any additional intranasal medication

Any history of head and neck irradiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 3 (week 12)

Summary

This trial tests a new nasal spray system for patients with chronic Eustachian tube dysfunction. The spray uses your breath to push medicine deeper into your nasal passages, aiming to improve treatment effectiveness.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not using any other nasal medications.

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I have had radiation therapy to my head or neck.

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I have had ear surgery, not including eardrum procedures.

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I have fluid in my middle ear.

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I have a ruptured eardrum.

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I have a history of head or neck cancer.

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I have glue ear.

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I have a tumor in the nasopharynx area.

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I have had issues or surgery on my jaw joint.

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I am under 18 years old.

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I have a cholesteatoma or a significant retraction in my ear.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 3 (week 12)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Eustachian Tube Dysfunction (ETD) include intranasal corticosteroids like fluticasone. These corticosteroids work by reducing inflammation in the nasal passages and Eustachian tubes, which helps to alleviate the blockage and improve ventilation of the middle ear. This is crucial for ETD patients as inflammation and swelling can prevent the Eustachian tubes from opening properly, leading to symptoms such as ear fullness, pain, and hearing difficulties. By reducing inflammation, corticosteroids help restore normal function and relieve these symptoms.