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