Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate
ConditionAsthma
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
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
Qualifiers
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.
Disqualifiers
Known hypersensitivity to fluticasone propionate
Allergy to olives or olive oil
Known allergy to oxymetazoline
Current smoking or vaping
Trial design
Treatments tested in this trial
- Fluticasone Propionate
- Water Mouthwash
- EVOOW Mouthwash
Treatment groups
20 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov