A Phase 4 interventional study of Fluticasone Propionate and Water Mouthwash in Asthma, sponsored by University of Wisconsin, Madison. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of Wisconsin, Madison · Phase 4, Interventional, and Treatment
This study aims to determine whether an extra virgin olive oil-based water (EVOOW) mixture removes more fluticasone propionate (FP) from the mouth than water alone. More effective removal of residual FP deposits may help reduce the risk of complications associated with inhaled corticosteroid use, including obstructive sleep apnea (OSA), oral candidiasis (thrush), and speech and swallowing dysfunction.
Participants will attend two separate testing visits, during which they will rinse and gargle with either EVOOW or water, after receiving 1 puff if fluticasone propionate. The visits will be scheduled 7-10 days apart. Total participation will last up to 3 weeks.
The objective of this study is to test a novel, Extra Virgin Olive-Oil-based Water (EVOOW) mix--designed to leverage ICS physicochemical molecular properties-- for improved removal of orally deposited Fluticasone Propionate (FP) delivered via a Metered Dose Inhaler (MDI) in patients with asthma.
The investigators hypothesize that EVOOW mouthwash will return a greater amount of orally deposited FP than Water rinse. Furthermore, because upper airway ICS deposition from a pressurized MDI is independent of inspiratory flow, the efficacy of EVOOW is not influenced by the presence of asthma.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 20 is below the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Fluticasone Propionate · Other: Water Mouthwash · Other: EVOOW Mouthwash
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.
Drug: Fluticasone Propionate · Other: Water Mouthwash · Other: EVOOW Mouthwash
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.
Drug: Fluticasone Propionate · Other: Water Mouthwash · Other: EVOOW Mouthwash
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.
Drug: Fluticasone Propionate · Other: Water Mouthwash · Other: EVOOW Mouthwash
Participants will be administered 1 puff of 220 micrograms FP, via Metered Dose Inhaler, without inhaling into the lungs.
Participants will rinse and gargle with 3 consecutive aliquots (20ml each) of either Water (W).
Participants will rinse and gargle with 3 consecutive aliquots (20 ml each) of an equal parts EVOO and Water mixture.
FP concentration in mouthwashes (ng/mL)
The primary outcome measure is FP concentration in mouthwashes, measured using mass spectrometry. The primary comparison of interest is the treatment-by-group interaction, representing the differential treatment effect (EVOOW vs. Water) between asthma and healthy participants. 3 separate 20ml aliquots will be administered and collected during each of 2 study visits, 7-10 days apart.
Time frame: data collected during each of two study visits, 7-10 days apart
FP drug extraction fraction (EFR)
3 separate 20ml aliquots will be administered and collected during each of 2 study visits, 7-10 days apart. FP drug extraction fraction (EFR) calculated as (\[measured FP concentration, ng/ml\]/220,000 ng FP delivered)\*100 on each of the aliquots.
Time frame: data collected during each of two study visits, 7-10 days apart
FP/Water EFR
3 separate 20ml aliquots will be administered and collected during each of 2 study visits, 7-10 days apart. FP/Water EFR trend across sequential aliquots, analyzed in the same fashion as the primary outcome.
Time frame: data collected during each of two study visits, 7-10 days apart
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Fluticasone
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