Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate (NCT07664527) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate
United States20 participantsStarted 2026-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a new method to remove fluticasone propionate that deposits in the mouth after using an inhaler — how does oral drug buildup currently affect my treatment, and could reducing it matter for my asthma management?
2Since this is a Phase 4 trial, meaning the drug itself is already approved, what specifically is still being studied here, and does that change the risk profile compared to what I'd experience with my current inhaler routine?
3The trial isn't recruiting yet — given that timeline, would it make sense to discuss this as a future option, or is there something I should be doing right now about oral fluticasone deposits with my existing inhaler?
4The main thing being measured is the concentration of fluticasone in mouthwash samples, which seems focused on a technique rather than asthma symptoms directly — does that mean participating wouldn't necessarily change how my asthma is treated day to day?
5Are there known side effects from fluticasone depositing in the mouth, like oral thrush, that this trial's rinsing method is trying to address, and would discussing this trial help us figure out better mouth-care habits for my current inhaler use regardless of whether I enroll?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
FP concentration in mouthwashes (ng/mL)
Timeframe: data collected during each of two study visits, 7-10 days apart