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NCT Number: NCT07664527

Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluticasone propionate

Drug

Participants will be administered 1 puff of 220 micrograms FP, via Metered Dose Inhaler, without inhaling into the lungs.

Water Mouthwash

Other

Participants will rinse and gargle with 3 consecutive aliquots (20ml each) of either Water (W).

EVOOW Mouthwash

Other

Participants will rinse and gargle with 3 consecutive aliquots (20 ml each) of an equal parts EVOO and Water mixture.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mihaela Teodorescu, MD, MS

CONTACT

[email protected]

608-256-1901

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Acronym: EVOOW

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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