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
This trial accepts healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Fluticasone Propionate
DrugParticipants will be administered 1 puff of 220 micrograms FP, via Metered Dose Inhaler, without inhaling into the lungs.
Water Mouthwash
Other interventionParticipants will rinse and gargle with 3 consecutive aliquots (20ml each) of either Water (W).
EVOOW Mouthwash
Other interventionParticipants will rinse and gargle with 3 consecutive aliquots (20 ml each) of an equal parts EVOO and Water mixture.
Treatment groups
20 Participants
are divided into 4 treatment groupsGroup A: Asthma: Water Then EVOOWExperimental treatment 3 interventions
Group B: Asthma: EVOOW Then WaterExperimental treatment 3 interventions
Group C: Healthy Control: Water Then EVOOWExperimental treatment 3 interventions
Group D: Healthy Control: EVOOW Then WaterExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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 apartSecondary outcomes
1
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 apart2
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 apartSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: