Effect of Novel Exhalational Delivery System with Fluticasone on Eustachian Tube Dysfunction

[InNeedOfHelp]

This study recently caught my eye for Eustachian Tube Dysfunction (ETD) and I wonder if anyone has already tried XHANCE (Fluticasone Propionate)?

It has been FDA approved and is available on the market as we speak. Because of the novel delivery mechanism the Fluticasone goes much deeper towards the Eustachian tubes.

Looking at the results this seems very promising for ETD (80% clinically significant improvement!). Am I missing something here? I cannot find a thread about this here on Tinnitus Talk? We know ETD can be a cause of tinnitus too.

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.​

I do not have access to the full study/research, it is located here:

PubMed: Effect of nasal fluticasone exhalation delivery system on Eustachian tube dysfunction

Does anyone have access to the full research paper?

A Phase 2 trial started this month:

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

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).​

 

[annV]

Does anyone have access to the full research paper?

Yes.

 

[InNeedOfHelp]

Optinose also positive designation for Chronic Sinusitis after positive Phase 3. No one in the US willing to treat their ETD with this spray? Seems like a groundbreaking treatment to me. They have mentioned that this Optinose system can deliver drugs directly past the blood brain barrier and therefore could become very important for neurologic medicines.

Unfortunately not available in the EU yet.

Optinose Announces Positive Top-line Results of ReOpen2, its second Phase 3 Clinical Trial of XHANCE for Treatment of Chronic Sinusitis

First Ever Phase 3 Program to Show Improvement in Both Symptoms and Inflammation Inside the Sinuses with a Nasal Therapy for Chronic Sinusitis Patients

Physicians Diagnose Chronic Sinusitis 10 Times More Frequently Than XHANCE's Current Nasal Polyps Indication and there is no FDA-Approved Medication for these Patients

Conference call and webcast to be held today at 8:30 a.m. Eastern Time

YARDLEY, Pa., June 13, 2022 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the statistically significant benefits of XHANCE in the ReOpen2 trial for both the symptoms co-primary endpoint and the CT scan co-primary endpoint. Significant improvement was demonstrated in patients with chronic sinusitis who did not have nasal polyps treated with both doses of XHANCE® (fluticasone propionate) nasal spray with the Exhalation Delivery System™ in the ReOpen2 clinical trial compared to patients receiving a vehicle Exhalation Delivery System (placebo). The co-primary endpoints were a patient-reported composite symptom score (comprising nasal congestion, facial pain or pressure, and nasal discharge) measured at week 4 and an objective measure of disease in the sinus cavities at week 24 (measured by average of the percentages of opacified volume on CT scan across the ethmoid and maxillary sinuses).​