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RECRUITING Phase 2

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

NCT05275686 · View on ClinicalTrials.gov ↗

Study 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).

Interventions

  • DRUG Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray
  • OTHER Placebo Nasal Spray

Study Locations (4)

California

  • Cedars-Sinai Medical Center — Los Angeles
  • Sacramento Ear, Nose & Throat — Sacramento

Indiana

  • Indiana University — Indianapolis

Louisiana

  • Ochsner Health System — New Orleans

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2022-04-20
Est. Completion 2027-12-31
Phase Phase 2

Sponsor

Cedars-Sinai Medical Center

360 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05275686

The ClinicalTrials.gov registry entry for NCT05275686 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 360 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Eustachian Tube Dysfunction appearing as the primary indexed condition, and to 2 interventions — of which Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05275686 reports 4 study locations spanning 3 distinct geographic areas — top geographies include California, Indiana, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05275686 about?

NCT05275686 is a clinical study titled "Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD)". 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 nasopharyn...

What is the current status of trial NCT05275686?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2022-04-20. Estimated completion is 2027-12-31.

What conditions does trial NCT05275686 study?

This clinical trial studies the following conditions: Eustachian Tube Dysfunction. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05275686?

The interventions under investigation include: Fluticasone Propionate 93 MCG/1 ACTUATION Nasal Spray (DRUG), Placebo Nasal Spray (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05275686?

This trial is sponsored by Cedars-Sinai Medical Center, which has 360 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05275686 being conducted?

This trial has 4 study locations across California, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial