Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate (EVOOW)

June 29, 2026 updated by: University of Wisconsin, Madison

A Proof-of-Concept Study of a Novel Method for Removal of Residual Oropharyngeal Inhaled Corticosteroid Deposits in Asthma

This study is to find out if an Extra Virgin Olive-Oil-based Water (EVOOW) mix, removes more Fluticasone Propionate (FP) from the mouth than Water alone. 2 strengths of the EVOOW mix will be tested, one with equal parts EVOO and Water (50/50) and one with 3 parts EVOO and 1 part Water (75/25). Removing more FP deposits may help decrease the risk for obstructive sleep apnea (OSA), candidiasis (thrush), and speech and swallow dysfunction. Participants will be on study for up to 3 weeks.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to test a novel, Extra Virgin Olive-Oil-based Water (EVOOW) mix--designed to leverage ICS physicochemical molecular properties-- for improved removal of orally deposited Fluticasone Propionate (FP) delivered via a Metered Dose Inhaler (MDI) in patients with asthma.

The investigators hypothesize that EVOOW mouthwash will return a greater amount of orally deposited FP than Water rinse. Furthermore, because upper airway ICS deposition from a pressurized MDI is independent of inspiratory flow, the efficacy of EVOOW is not influenced by the presence of asthma.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adults and adults with asthma, age 18 years and older
  • Willing to hold orally and nasally inhaled corticosteroids (ICS) for 24h and 12h, respectively, before study visits with mouthwash sample collections (Visit 2 and Visit 3)
  • No systemic or topical ocular corticosteroid use for the prior 4 weeks.

Exclusion Criteria:

  • Known hypersensitivity to fluticasone propionate
  • Allergy to olives or olive oil
  • Known allergy to oxymetazoline
  • Current smoking or vaping
  • Currently pregnant or trying to become pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Asthma: Water Then EVOOW
After FP administration, participants will rinse and gargle with 3 consecutive aliquots of either Water (W) or EVOOW mix each on separate days, 7-10 days apart, assigned in random order.
Drug: Fluticasone Propionate
Participants will be administered 1 puff of 220 micrograms FP, via Metered Dose Inhaler, without inhaling into the lungs.
Other: Water Mouthwash
Participants will rinse and gargle with 3 consecutive aliquots (20ml each) of either Water (W).
Other: EVOOW Mouthwash
Participants will rinse and gargle with 3 consecutive aliquots (20 ml each) of an equal parts EVOO and Water mixture.
Experimental: Asthma: EVOOW Then Water
After FP administration, participants will rinse and gargle with 3 consecutive aliquots of either Water (W) or EVOOW mix each on separate days, 7-10 days apart, assigned in random order.
Drug: Fluticasone Propionate
Participants will be administered 1 puff of 220 micrograms FP, via Metered Dose Inhaler, without inhaling into the lungs.
Other: Water Mouthwash
Participants will rinse and gargle with 3 consecutive aliquots (20ml each) of either Water (W).
Other: EVOOW Mouthwash
Participants will rinse and gargle with 3 consecutive aliquots (20 ml each) of an equal parts EVOO and Water mixture.
Experimental: Healthy Control: Water Then EVOOW
After FP administration, participants will rinse and gargle with 3 consecutive aliquots of either Water (W) or EVOOW mix each on separate days, 7-10 days apart, assigned in random order.
Drug: Fluticasone Propionate
Participants will be administered 1 puff of 220 micrograms FP, via Metered Dose Inhaler, without inhaling into the lungs.
Other: Water Mouthwash
Participants will rinse and gargle with 3 consecutive aliquots (20ml each) of either Water (W).
Other: EVOOW Mouthwash
Participants will rinse and gargle with 3 consecutive aliquots (20 ml each) of an equal parts EVOO and Water mixture.
Experimental: Healthy Control: EVOOW Then Water
After FP administration, participants will rinse and gargle with 3 consecutive aliquots of either Water (W) or EVOOW mix each on separate days, 7-10 days apart, assigned in random order.
Drug: Fluticasone Propionate
Participants will be administered 1 puff of 220 micrograms FP, via Metered Dose Inhaler, without inhaling into the lungs.
Other: Water Mouthwash
Participants will rinse and gargle with 3 consecutive aliquots (20ml each) of either Water (W).
Other: EVOOW Mouthwash
Participants will rinse and gargle with 3 consecutive aliquots (20 ml each) of an equal parts EVOO and Water mixture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FP concentration in mouthwashes (ng/mL)
Time Frame: data collected during each of two study visits, 7-10 days apart
The primary outcome measure is FP concentration in mouthwashes, measured using mass spectrometry. The primary comparison of interest is the treatment-by-group interaction, representing the differential treatment effect (EVOOW vs. Water) between asthma and healthy participants. 3 separate 20ml aliquots will be administered and collected during each of 2 study visits, 7-10 days apart.
data collected during each of two study visits, 7-10 days apart

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FP drug extraction fraction (EFR)
Time Frame: data collected during each of two study visits, 7-10 days apart

3 separate 20ml aliquots will be administered and collected during each of 2 study visits, 7-10 days apart.

FP drug extraction fraction (EFR) calculated as ([measured FP concentration, ng/ml]/220,000 ng FP delivered)*100 on each of the aliquots.
data collected during each of two study visits, 7-10 days apart
FP/Water EFR
Time Frame: data collected during each of two study visits, 7-10 days apart

3 separate 20ml aliquots will be administered and collected during each of 2 study visits, 7-10 days apart.

FP/Water EFR trend across sequential aliquots, analyzed in the same fashion as the primary outcome.
data collected during each of two study visits, 7-10 days apart

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Mihaela Teodorescu, MD, MS, UW School of Medicine and Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

June 17, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0874
  • Protocol Version 2/2/26 (Other Identifier: UW Madison)
  • SMPH | DOM Pulmonary and Crit (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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