Eustachian Tube DysfunctionPhase 2NCT05275686
Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD)
A Phase 2 study testing Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray in people with Eustachian Tube Dysfunction, run by Cedars-Sinai Medical Center at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Eustachian Tube Dysfunction
- What is being tested?
- Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Apr 2022to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Elisa Illing, MD, eilling@iu.edu
Joey Calcagno, jcalcagn@iu.edu
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Missael Vasquez, 424-315-2437, missael.vasquez@cshs.org
Laura Sarmiento, CCRP, 310-423-4295, laura.sarmiento@cshs.org
- Recruiting
Ochsner Health System
New Orleans, Louisiana, 70121
Edward McCoul, MD, edward.mccoul@ochsner.org
Edward McCoul, MD
- Recruiting
Sacramento Ear, Nose & Throat
Sacramento, California, 95661
Rose Khalatyan, 916-531-2788, rkhalatyan@davinciresearch.net
Randall A Ow, MD, row@sacent.com
About this study
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
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).
Read the 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.
- Conditions
- Eustachian Tube Dysfunction
- Being tested
- Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray, Placebo Nasal Spray
- Keywords
- Eustachian Tube Dysfunction, Fluticasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone Propionate 93 MCG/1 ACTUATION Nasal SprayDrug
Patients will use two sprays in each nostril twice a day for 6 weeks and additional 6 weeks (open label).
Placebo Nasal SprayOther
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Placebo) | Placebo comparator | Arm 1 (placebo) will get placebo spray per day. Receives: Other: Placebo Nasal Spray |
| Arm 2 (EDS-FLU) | Active comparator | Arm 2 (EDS-FLU) will get 744 mcg of fluticasone propionate per day. Receives: Drug: Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-Item Eustachian Tube Dysfunction Questionnaire (ETDQ-7)
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).
Measured: visit 2 (week 6)
7-Item Eustachian Tube Dysfunction Questionnaire (ETDQ-7)
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).
Measured: visit 3 (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start20 Apr 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eustachian Tube DysfunctionStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sacramento Ear, Nose & Throat, Ochsner Health System, Indiana University
- Responsible party
- Principal investigator, Arthur Wu, Cedars-Sinai Medical Center
- Investigators
- Arthur Wu, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275686
- Sponsor's protocol ID
- IIT-WU-2021-EuPEN
- Status last verified
- Mar 2026
- First submitted
- 22 Feb 2022
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05275686
- Acronym / sponsor ID
- IIT-WU-2021-EuPEN
- Conditions
- Eustachian Tube Dysfunction
- Keywords
- Eustachian Tube Dysfunction, Fluticasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Sacramento Ear, Nose & Throat, Ochsner Health System, Indiana University
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Placebo) | Placebo comparator | Other: Placebo Nasal SprayArm 1 (placebo) will get placebo spray per day. |
| Arm 2 (EDS-FLU) | Active comparator | Drug: Fluticasone Propionate 93 MCG/1 ACTUATION Nasal SprayArm 2 (EDS-FLU) will get 744 mcg of fluticasone propionate per day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than or equal to 18 years old, <80 years old
- Chronic Eustachian tube dysfunction defined as:
- Female subjects of childbearing potential must have a negative urine pregnancy test at screening and throughout the study duration.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone Propionate 93 MCG/1 ACTUATION Nasal SprayPatients will use two sprays in each nostril twice a day for 6 weeks and additional 6 weeks (open label). | Drug | Arm 2 (EDS-FLU) |
| Placebo Nasal SprayThe 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 | Other | Arm 1 (Placebo) |
Primary outcome
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arthur Wu, MD principal investigator
Cedars-Sinai Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray in people with Eustachian Tube Dysfunction, run by Cedars-Sinai Medical Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Missael Vasquez (424-315-2437, missael.vasquez@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-Item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) (time frame: visit 2 (week 6)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.