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Not Yet Recruiting NCT07664527

Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate

Conditions: Asthma

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 20
Sponsor: University of Wisconsin, Madison

Location: University of Wisconsin Madison Wisconsin

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07664527). StuddyBuddy aggregates publicly available trial information.