Fluticasone Nasal Spray for Eustachian Tube Dysfunction

Recruiting at 3 trial locations

Overseen By Laura Sarmiento, CCRP

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cedars-Sinai Medical Center

Must be taking: Intranasal steroids

Must not be taking: Intranasal medication

Disqualifiers: Otologic surgery, Head cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether a new nasal spray system using fluticasone, a corticosteroid, can effectively treat Eustachian tube dysfunction (ETD), a condition causing persistent ear issues like fullness or pain. Participants will receive either the fluticasone spray or a placebo (a spray with no active medication) to compare results. It suits adults with ongoing ear symptoms for more than three months. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you do not use any additional intranasal medication. Other medications are not mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatment is likely to be safe?

Research shows that fluticasone nasal spray is generally safe. Studies have found its safety comparable to a placebo, meaning users did not experience more side effects than those using a non-active spray. At the doses used, there is no risk of adrenal suppression, a condition where the body doesn't produce enough hormones. Fluticasone nasal sprays are often available over-the-counter for conditions like hay fever, indicating they are well-tolerated by most people. For those considering joining a trial with fluticasone, these findings suggest it is a safe option. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Eustachian tube dysfunction?

Unlike the standard treatments for Eustachian Tube Dysfunction, which often include decongestants, antihistamines, or surgical interventions, fluticasone propionate offers a unique approach by utilizing a corticosteroid nasal spray to reduce inflammation directly. This method targets the root cause of dysfunction by reducing the swelling and blockage in the Eustachian tubes, potentially offering a non-invasive and convenient alternative. Researchers are excited about this treatment because it could offer relief with fewer side effects compared to systemic medications, and it may be easier to use regularly than surgical options.

What evidence suggests that this treatment might be an effective treatment for Eustachian tube dysfunction?

Research has shown that fluticasone nasal spray can alleviate symptoms for people with Eustachian tube dysfunction (ETD). In this trial, one group of participants will receive 744 mcg of fluticasone propionate daily. A study found that a specialized delivery method for fluticasone helped most patients with long-term ETD improve. This method aims to deliver the medicine more effectively to the target area. While fluticasone is commonly used for nasal issues like allergies and sinus problems, this new system shows promise for treating ETD specifically. The treatment is generally safe and often available without a prescription. ^{1 2 4 6 7}

Who Is on the Research Team?

Arthur Wu, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a woman who can have children and have a negative pregnancy test.

I have had ear problems for more than 3 months and a specific test score above 14.5.

Exclusion Criteria

I have fluid in my middle ear.

I have a ruptured eardrum.

I have glue ear.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either placebo or 744 mcg of fluticasone propionate per day using the EDS-FLU system

6 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fluticasone Propionate

Trial Overview

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.

How Is the Trial Designed?

Group I: Arm 2 (EDS-FLU) Active Control 1 Intervention

Arm 2 (EDS-FLU) will get 744 mcg of fluticasone propionate per day.

Group II: Arm 1 (Placebo) Placebo Group 1 Intervention

Arm 1 (placebo) will get placebo spray per day.

Fluticasone Propionate is already approved in United States, European Union for the following indications:

Approved in United States as Enbrel for:

• Moderate to Severe Rheumatoid Arthritis
• Moderate to Severe Polyarticular Juvenile Rheumatoid Arthritis
• Psoriatic Arthritis
• Ankylosing Spondylitis
• Moderate to Severe Plaque Psoriasis

Approved in European Union as Enbrel for:

• Rheumatoid Arthritis
• Juvenile Idiopathic Arthritis
• Psoriatic Arthritis
• Ankylosing Spondylitis
• Plaque Psoriasis

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

Sacramento Ear, Nose & Throat

Collaborator

Trials

1

Recruited

80+

Ochsner Health System

Collaborator

Trials

97

Recruited

91,900+

Published Research Related to This Trial

Fluticasone propionate is an effective treatment for nasal symptoms in both seasonal and perennial allergic rhinitis, supported by large clinical studies involving nearly 4000 patients, showing comparable efficacy to other intranasal corticosteroids and better results than some oral antihistamines.

The safety profile of intranasal fluticasone propionate is favorable, with adverse effects similar to placebo and no risk of adrenal suppression at doses up to 4 mg/day, making it a convenient once-daily option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intranasal fluticasone propionate. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in allergic rhinitis. Bryson, HM., Faulds, D.[2018]

Fluticasone furoate nasal spray (FFNS) 110 microg once daily significantly improved nasal and ocular symptoms of seasonal allergic rhinitis (SAR) in a study of 302 participants aged 12 and older, with notable reductions in total nasal symptom scores compared to placebo.

FFNS was found to have a favorable safety profile, with fewer adverse events reported (22%) compared to placebo (29%), and no serious adverse events were observed during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of fluticasone furoate 110 microg once daily in the treatment of nasal and ocular symptoms of seasonal allergic rhinitis in adults and adolescents sensitized to mountain cedar pollen. Jacobs, R., Martin, B., Hampel, F., et al.[2012]

In a 6-week study involving 302 patients aged 12 and older, intranasal fluticasone furoate significantly reduced nasal symptoms of perennial allergic rhinitis compared to placebo, with a notable mean difference in total nasal symptom score (TNSS) of -1.256 (p < 0.001).

Fluticasone furoate also improved ocular symptoms and daily peak nasal inspiratory flow (PNIF), demonstrating its efficacy in treating both nasal and eye-related symptoms of allergic rhinitis, while being well tolerated by participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluticasone furoate nasal spray: effective monotherapy for symptoms of perennial allergic rhinitis in adults/adolescents. Vasar, M., Houle, PA., Douglass, JA., et al.[2016]

In a 4-week study involving 28 patients with allergic rhinitis, the MP29-02 nasal spray significantly reduced nasal hyperreactivity and inflammatory mediators compared to placebo, indicating its efficacy in treating allergic rhinitis.

The mechanism of action for MP29-02 includes restoring nasal epithelial barrier function and desensitizing sensory neurons, which may help alleviate symptoms of allergic rhinitis by reducing inflammation and improving nasal airflow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MP29-02 reduces nasal hyperreactivity and nasal mediators in patients with house dust mite-allergic rhinitis. Kortekaas Krohn, I., Callebaut, I., Alpizar, YA., et al.[2022]

Fluticasone furoate (FF) effectively inhibits the secretion of key inflammatory cytokines (GM-CSF, IL-6, and IL-8) from nasal mucosa epithelial cells, suggesting its potential to reduce inflammation in allergic rhinitis.

FF also significantly decreases the survival of eosinophils, which are involved in allergic responses, indicating that it may help control eosinophilic inflammation in the upper airways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluticasone furoate inhibits cytokine secretion from nasal epithelial cells and reduces eosinophil survival in an in vitro model of eosinophilic inflammation. Mullol, J., Pujols, L., Alobid, I., et al.[2022]

In a study involving 105 adults with allergic rhinitis, fluticasone propionate aqueous nasal spray (FP ANS) did not significantly alter HPA-axis function after 4 weeks of treatment, indicating it is safe in terms of adrenal function.

In contrast, oral prednisone at doses of 7.5 mg and 15 mg significantly reduced HPA-axis function, as shown by lower plasma cortisol levels, highlighting that FP ANS may be a safer alternative for managing allergic rhinitis without the risk of adrenal suppression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of fluticasone propionate aqueous nasal spray versus oral prednisone on the hypothalamic-pituitary-adrenal axis. Vargas, R., Dockhorn, RJ., Findlay, SR., et al.[2019]

The study found that the fixed-combination fluticasone propionate-azelastine nasal spray (MP-AzeFlu) penetrates nasal tissues more rapidly than the fluticasone propionate-only nasal spray, suggesting quicker relief for patients with allergic rhinitis.

Both nasal sprays showed similar overall accumulation of fluticasone propionate, but MP-AzeFlu demonstrated greater permeability in the first 6 hours, indicating it may provide faster symptom relief without compromising tissue integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of in vitro Penetration of Fluticasone Propionate from MP-AzeFlu and Fluticasone Propionate Nasal Spray Through EpiAirway™606 Tissues Using Vertical Diffusion Cells. Berger, WE., Bachert, C., Allara, R., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05275686

Study Details | NCT05275686 | Effect of Novel Exhalational ...

These sprays do have good safety profiles, are frequently available over-the-counter, and do have good data on their efficacy in rhinitis and sinusitis. ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1939455123001205

Allergy in pathogenesis of Eustachian Tube Dysfunction

The use of novel fluticasone propionate exhalation delivery system can improve symptoms in the majority of chronic ETD patients. Y. Mehta et al. 2022 ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11748195/

Conventional nasal spray vs. exhalation delivery system ...

This study utilizes a cadaver model to examine topical NP delivery using EDS vs. NS before and after targeted endoscopic sinus surgery (ESS).

4.

withpower.com

withpower.com/trial/phase-2-eustachian-tube-dysfunction-etd-2-2022-3f7e5

Fluticasone Nasal Spray for Eustachian Tube Dysfunction

In a 6-week study involving 302 patients aged 12 and older, intranasal fluticasone furoate significantly reduced nasal symptoms of perennial allergic rhinitis ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36416201/

Eustachian Tube Dysfunction in Children with Adenoid ...

In this study, it was observed that Aze-Flu treatment was significantly effective in both regression of the adenoid tissue and Eustachian tube dysfunction.

6.

mayoclinic.org

mayoclinic.org/drugs-supplements/fluticasone-nasal-route/description/drg-20070965

Fluticasone (nasal route) - Side effects & dosage

Fluticasone nasal spray is used to treat sneezing, itchy or runny nose, or other symptoms caused by hay fever.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4819470/

Intranasal Fluticasone Propionate Observational Cohort ...

The FPNS results were consistent with the risk profile for INS and did not raise any new safety signals at the time of study conduct, which is consistent with ...