Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07664527
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

FP concentration in mouthwashes (ng/mL) [ Time Frame: data collected during each of two study visits, 7-10 days apart ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53792-

Find similar trials in Madison, WI

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
University of Wisconsin· Madison, WI

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