Fluticasone Nasal Spray for Eustachian Tube Dysfunction

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Arthur Wu, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

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

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Fluticasone Propionate for Eustachian Tube Dysfunction?

Research shows that Fluticasone Propionate is effective in treating nasal symptoms of allergic rhinitis, which involves inflammation similar to that in Eustachian Tube Dysfunction. It reduces inflammation and nasal symptoms, suggesting it might help with similar issues in the Eustachian tube. ^{1 2 3 4 5}

Is fluticasone nasal spray safe for humans?

Fluticasone nasal spray has been studied in large clinical trials for allergic rhinitis, showing a safety profile similar to placebo. Common side effects include nasal dryness, burning, nosebleeds, and headaches, but it does not cause significant systemic effects like adrenal suppression. ^{1 3 4 5 6}

How does the drug fluticasone propionate nasal spray differ from other treatments for Eustachian Tube Dysfunction?

Fluticasone propionate nasal spray is unique because it is a potent anti-inflammatory corticosteroid with low systemic activity, designed for intranasal use, which minimizes systemic side effects. Its low oral bioavailability and minimal systemic absorption make it a safer option compared to oral corticosteroids, and it is primarily used for conditions like allergic rhinitis, which may indirectly benefit Eustachian Tube Dysfunction by reducing nasal inflammation. ^{1 2 5 6 7}

Research Team

Arthur Wu, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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 between 18 and 79 years old.

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.

Trial Timeline

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

Treatment Details

Interventions

• Fluticasone Propionate (Corticosteroid)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

David E. Cohen

Cedars-Sinai Medical Center

Chief Medical Officer

MD and PhD in Physiology and Biophysics from Harvard University

Peter L. Slavin

Cedars-Sinai Medical Center

Chief Executive Officer

MD from Harvard Medical School, MBA from Harvard Business School

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

Alan Palkowitz

Indiana University

Chief Executive Officer since 2020

PhD in Chemistry from Indiana University

David Ingram

Indiana University

Chief Medical Officer since 2020

MD from Indiana University School of Medicine

Sacramento Ear, Nose & Throat

Collaborator

Trials

1

Recruited

80+

Ochsner Health System

Collaborator

Trials

97

Recruited

91,900+

Pete November

Ochsner Health System

Chief Executive Officer since 2022

JD from Louisiana State University

Robert Hart

Ochsner Health System

Chief Medical Officer since 2022

MD

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2012]

2. New Zealand 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Fluticasone furoate nasal spray: effective monotherapy for symptoms of perennial allergic rhinitis in adults/adolescents. [2016]

4. Switzerland 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. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

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

6. Denmark pubmed.ncbi.nlm.nih.gov

MP29-02 reduces nasal hyperreactivity and nasal mediators in patients with house dust mite-allergic rhinitis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of fluticasone propionate aqueous nasal spray versus oral prednisone on the hypothalamic-pituitary-adrenal axis. [2019]