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Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD)

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ClinicalTrials.gov Identifier: NCT05275686
Recruitment Status : Recruiting
First Posted : March 11, 2022
Last Update Posted : May 20, 2022
Sponsor:
Information provided by (Responsible Party):
Arthur Wu, Cedars-Sinai Medical Center

Brief Summary:
Intranasal nasal steroid sprays are the mainstay of treatment for chronic Eustachian tube dysfunction despite having little supportive evidence in the literature. A novel, commercially available nasal spray delivery system is available now for fluticasone that improves its delivery to the nasopharynx. The hypothesis of this study is that fluticasone using the novel spray system is effective for Eustachian tube dysfunction (ETD).

Condition or disease Intervention/treatment Phase
Eustachian Tube Dysfunction Drug: Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray Other: Placebo Nasal Spray Phase 2

Detailed Description:

BACKGROUND AND RATIONALE

Eustachian tube dysfunction (ETD) can be a symptom of allergic rhinitis, non-allergic rhinitis, or chronic rhinosinusitis. However, it can also be a separate entity with patients displaying no other symptoms of the previously mentioned diseases. There is currently no FDA- approved medication specifically for eustachian tube dysfunction, but most otolaryngologists, allergists, and primary care physicians employ multiple different over-the-counter and prescription medications for its treatment. Most common are oral and topical antihistamines, nasal steroid sprays, topical and oral decongestants, and oral steroids. Nasal steroid sprays, which are FDA-approved for allergic rhinitis, are most frequently used for chronic ETD despite a lack of large clinical trials to support their use. 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.

Fluticasone nasal spray is available over the counter and is a nasal steroid spray. It is frequently recommended or prescribed for chronic eustachian tube dysfunction. However, its efficacy and the efficacy of all nasal sprays may be limited by the access of previously available sprays into the nasopharynx. The level of evidence for these sprays in chronic ETD is poor overall with only one randomized controlled trial in adults. This study determined no benefit over placebo. In studies determining the deposition of nasal sprays, most of the spray is deposited in the front of the nasal cavity over the inferior turbinates and very little gets into the sinus cavities or nasopharynx. A new exhalational delivery system fluticasone spray (EDS-FLU) has been FDA-approved for patients with chronic rhinosinusitis with polyps. The main difference between this spray and previously available sprays is that it penetrates deeper into the sinuses and also to the nasopharynx, the location of the eustachian tubes. In this system, the user blows out while pumping the spray bottle and his/her breath is the driving force of the spray bottle. Blowing out also elevates the soft palate, seals the nasopharynx, and contains all the spray into the nasal cavity, sinuses, and nasopharynx. In a traditional spray, the soft palate is at resting position, and the spray can pass through the nasal cavity and down into the oropharynx and mouth. This is typically perceived by many users as postnasal drip after the use of nasal sprays. The investigators have previously published a retrospective review of the use of EDS-FLU in patients with at least 1 month of ETD symptoms and found that 79% had improvement more than the minimal clinically important difference. Thirty-six percent of patients normalized with regards to symptoms, and 80% of patients with pre- and post-treatment tympanometry normalized their tympanogram. This study will compare placebo to fluticasone exhalational nasal spray system (Xhance) in a randomized, controlled study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • Group 1 will get the EDS-FLU nasal spray and use at its normal twice a day dosing.
  • Group 2 will get the placebo nasal spray in an identical spray canister and use it twice a day.

Patients will be randomized to receive placebo in the novel exhalation delivery system versus fluticasone in the device. Patients will take the spray twice daily for six weeks and then return for evaluation. An open label extension will be planned for both groups (placebo, non-placebo) at the end of the six weeks to use the EDS-FLU for an additional six weeks.

Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Patients and investigators will be kept blinded until the end of the study.
Primary Purpose: Treatment
Official Title: Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD) in a Multi-center, Double-Blinded, Placebo-controlled Trial
Actual Study Start Date : April 20, 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu

Arm Intervention/treatment
Placebo Comparator: Arm 1 (Placebo)
Arm 1 (placebo) will get placebo spray per day.
Other: Placebo Nasal Spray
The Placebo is made of the following ingredients: Purified Water, Microcrystalline Cellulose RC-591, Dextrose, Anhydrous, EDTA Disodium Dihydrate, Benzalkonium Chloride Solution 50%, Polysorbate 80 (Tween 80, HP-LQ-(MH)), Sodium Hydroxide, and Hydrochloric Acid. Patients will use two sprays in each nostril twice a day

Active Comparator: Arm 2 (EDS-FLU)
Arm 2 (EDS-FLU) will get 744 mcg of fluticasone propionate per day.
Drug: Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray
Patients will use two sprays in each nostril twice a day for 6 weeks and additional 6 weeks (open label).




Primary Outcome Measures :
  1. 7-Item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) [ Time Frame: visit 2 (week 6) ]

    Eustachian tube dysfunction symptoms measured by the validated quality of life 7-Item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) at visit 2.

    The scale is from 1 (no problem) to 7 (severe problem).


  2. 7-Item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) [ Time Frame: visit 3 (week 12) ]

    Eustachian tube dysfunction symptoms measured by the validated quality of life 7-Item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) at visit 3.

    The scale is from 1 (no problem) to 7 (severe problem).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 AND
    • ETDQ-7 score >14.5 AND
    • Type B, C, or As tympanometry
  • Female subjects of childbearing potential must have a negative urine pregnancy test at screening and throughout the study duration.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05275686


Contacts
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Contact: Jenny Park, MPH, CCRP 310-423-8762 jenny.park@cshs.org

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Jenny Park, MPH, CCRP    310-423-8762    jenny.park@cshs.org   
Principal Investigator: Arthur Wu, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Arthur Wu, MD Cedars-Sinai Medical Center
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Responsible Party: Arthur Wu, Principal Investigator, MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT05275686    
Other Study ID Numbers: IIT-WU-2021-EuPEN
First Posted: March 11, 2022    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Arthur Wu, Cedars-Sinai Medical Center:
Eustachian Tube Dysfunction
Fluticasone
Additional relevant MeSH terms:
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Fluticasone
Xhance
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents