Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate

NCT07664527 | Not Yet Recruiting Phase 4 FDA Drug

• 3 other identifiers: 2022-0874Protocol Version 2/2/26SMPH | DOM Pulmonary and Crit
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Keywords

Fluticasone Propionate; EVOO; upper airway; oral deposits; inhaler

Outcome Measures

Primary Outcomes (1)

• FP concentration in mouthwashes (ng/mL)

  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 Outcomes (2)

• FP drug extraction fraction (EFR)

  data collected during each of two study visits, 7-10 days apart

• FP/Water EFR

  data collected during each of two study visits, 7-10 days apart

Study Arms (4)

Asthma: Water Then EVOOW

EXPERIMENTAL

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; Other: Water Mouthwash; Other: EVOOW Mouthwash

Asthma: EVOOW Then Water

EXPERIMENTAL

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; Other: Water Mouthwash; Other: EVOOW Mouthwash

Healthy Control: Water Then EVOOW

EXPERIMENTAL

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; Other: Water Mouthwash; Other: EVOOW Mouthwash

Healthy Control: EVOOW Then Water

EXPERIMENTAL

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; Other: Water Mouthwash; Other: EVOOW Mouthwash

Interventions

Fluticasone Propionate DRUG

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

Asthma: EVOOW Then Water; Asthma: Water Then EVOOW; Healthy Control: EVOOW Then Water; Healthy Control: Water Then EVOOW

Water Mouthwash OTHER

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

Asthma: EVOOW Then Water; Asthma: Water Then EVOOW; Healthy Control: EVOOW Then Water; Healthy Control: Water Then EVOOW

EVOOW Mouthwash OTHER

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

Asthma: EVOOW Then Water; Asthma: Water Then EVOOW; Healthy Control: EVOOW Then Water; Healthy Control: Water Then EVOOW

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mihaela Teodorescu, MD, MS

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mihaela Teodorescu, MD, MS

CONTACT

608-256-1901; mt3@medicine.wisc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, unblinded, randomized, controlled, crossover study with 2 oral rinse conditions: Water (control) and EVOO and Water mix (treatment) in equal 1:1 (EVOOW) proportions, in participants with asthma in stable condition and healthy controls. Following phenotyping with nasal, tongue and pulmonary function testing, participants with asthma (n=10) and healthy controls (n=10) will be randomized to test on each condition at separate visits. Samples will be analyzed for FP concentration via mass spectrometry.

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)