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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 2/2/26 | Other Identifier | UW Madison | |
| SMPH | DOM Pulmonary and Crit | Other Identifier | UW Madison |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asthma: Water Then EVOOW | Experimental | 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. |
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| Asthma: EVOOW Then Water | Experimental | 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. |
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| Healthy Control: Water Then EVOOW | Experimental | 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. |
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| Healthy Control: EVOOW Then Water | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Propionate | Drug | Participants will be administered 1 puff of 220 micrograms FP, via Metered Dose Inhaler, without inhaling into the lungs. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | data collected during each of two study visits, 7-10 days apart |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | data collected during each of two study visits, 7-10 days apart |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mihaela Teodorescu, MD, MS | Contact | 608-256-1901 | mt3@medicine.wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mihaela Teodorescu, MD, MS | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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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.
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| Water Mouthwash | Other | Participants will rinse and gargle with 3 consecutive aliquots (20ml each) of either Water (W). |
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| EVOOW Mouthwash | Other | Participants will rinse and gargle with 3 consecutive aliquots (20 ml each) of an equal parts EVOO and Water mixture. |
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| 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. | data collected during each of two study visits, 7-10 days apart |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |