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

Sponsor

Cedars-Sinai Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05275686

Collaborator

(none)

Enrollment

Location

Arms

11.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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.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 :

Apr 20, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

7-Item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) [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).
7-Item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048

Sponsors and Collaborators

Cedars-Sinai Medical Center

Investigators

Principal Investigator: Arthur Wu, MD, Cedars-Sinai Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Mar 11, 2022

Last Update Posted:

May 20, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Arthur Wu, Principal Investigator, MD, Cedars-Sinai Medical Center

Eustachian Tube Dysfunction

Fluticasone

Additional relevant MeSH terms:

Fluticasone

Xhance

Study Results

No Results Posted as of May 20, 2022