Asthma
Conditions
Keywords
Fluticasone Propionate, EVOO, upper airway, oral deposits, inhaler
Brief 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.
Detailed description
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.
Interventions
DRUGFluticasone Propionate
Participants will be administered 1 puff of 220 micrograms FP, via Metered Dose Inhaler, without inhaling into the lungs.
OTHERWater Mouthwash
Participants will rinse and gargle with 3 consecutive aliquots (20ml each) of either Water (W).
OTHEREVOOW Mouthwash
Participants will rinse and gargle with 3 consecutive aliquots (20 ml each) of an equal parts EVOO and Water mixture.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, unblinded, randomized, controlled, crossover study with 2 oral rinse conditions: Water (control) and EVOO and Water mix (treatment) in equal 1:1 (EVOOW) proportions, in participants with asthma in stable condition and healthy controls. Following phenotyping with nasal, tongue and pulmonary function testing, participants with asthma (n=10) and healthy controls (n=10) will be randomized to test on each condition at separate visits. Samples will be analyzed for FP concentration via mass spectrometry.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FP concentration in mouthwashes (ng/mL) | data collected during each of two study visits, 7-10 days apart | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FP drug extraction fraction (EFR) | data collected during each of two study visits, 7-10 days apart | 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. |
| FP/Water EFR | data collected during each of two study visits, 7-10 days apart | 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. |
Countries
United States
Contacts
CONTACTMihaela Teodorescu, MD, MS
PRINCIPAL_INVESTIGATORMihaela Teodorescu, MD, MS
UW School of Medicine and Public Health
Outcome results
None listed