AsthmaPhase 4EVOOWNCT07664527
Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate
A Phase 4 study testing Fluticasone Propionate, Water Mouthwash and EVOOW Mouthwash in people with Asthma, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone Propionate, Water Mouthwash and EVOOW Mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Proof-of-Concept Study of a Novel Method for Removal of Residual Oropharyngeal Inhaled Corticosteroid Deposits in Asthma
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Fluticasone Propionate, Water Mouthwash, EVOOW Mouthwash
- Keywords
- Fluticasone Propionate, EVOO, upper airway, oral deposits, inhaler
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone PropionateDrug
Participants will be administered 1 puff of 220 micrograms FP, via Metered Dose Inhaler, without inhaling into the lungs.
Water MouthwashOther
Participants will rinse and gargle with 3 consecutive aliquots (20ml each) of either Water (W).
EVOOW MouthwashOther
Participants will rinse and gargle with 3 consecutive aliquots (20 ml each) of an equal parts EVOO and Water mixture.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Fluticasone Propionate; Other: Water Mouthwash; Other: EVOOW Mouthwash |
| 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. Receives: Drug: Fluticasone Propionate; Other: Water Mouthwash; Other: EVOOW Mouthwash |
| 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. Receives: Drug: Fluticasone Propionate; Other: Water Mouthwash; Other: EVOOW Mouthwash |
| 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. Receives: Drug: Fluticasone Propionate; Other: Water Mouthwash; Other: EVOOW Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: data collected during each of two study visits, 7-10 days apart
Secondary outcomes (2)
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.
Measured: 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.
Measured: data collected during each of two study visits, 7-10 days apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study startNov 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mihaela Teodorescu, MD, MS, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664527
- Sponsor's protocol ID
- 2022-0874
- Other IDs
- Protocol Version 9/16/26, SMPH | DOM Pulmonary and Crit
- Acronym
- EVOOW
- Status last verified
- Nov 2026
- First submitted
- 17 Jun 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-Concept Study of a Novel Method for Removal of Residual Oropharyngeal Inhaled Corticosteroid Deposits in Asthma
- ClinicalTrials.gov ID
- NCT07664527
- Acronym / sponsor ID
- EVOOW / 2022-0874
- Conditions
- Asthma
- Keywords
- Fluticasone Propionate, EVOO, upper airway, oral deposits, inhaler
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Asthma: Water Then EVOOW | Experimental | Drug: Fluticasone Propionate, Other: Water Mouthwash, Other: EVOOW MouthwashAfter 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. |
| Asthma: EVOOW Then Water | Experimental | Drug: Fluticasone Propionate, Other: Water Mouthwash, Other: EVOOW MouthwashAfter 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. |
| Healthy Control: Water Then EVOOW | Experimental | Drug: Fluticasone Propionate, Other: Water Mouthwash, Other: EVOOW MouthwashAfter 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. |
| Healthy Control: EVOOW Then Water | Experimental | Drug: Fluticasone Propionate, Other: Water Mouthwash, Other: EVOOW MouthwashAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone PropionateParticipants will be administered 1 puff of 220 micrograms FP, via Metered Dose Inhaler, without inhaling into the lungs. | Drug | Asthma: EVOOW Then Water, Asthma: Water Then EVOOW, Healthy Control: EVOOW Then Water, Healthy Control: Water Then EVOOW |
| Water MouthwashParticipants will rinse and gargle with 3 consecutive aliquots (20ml each) of either Water (W). | Other | Asthma: EVOOW Then Water, Asthma: Water Then EVOOW, Healthy Control: EVOOW Then Water, Healthy Control: Water Then EVOOW |
| EVOOW MouthwashParticipants will rinse and gargle with 3 consecutive aliquots (20 ml each) of an equal parts EVOO and Water mixture. | Other | Asthma: EVOOW Then Water, Asthma: Water Then EVOOW, Healthy Control: EVOOW Then Water, Healthy Control: Water Then EVOOW |
Primary outcome
FP concentration in mouthwashes (ng/mL)
Time frame: 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.
2 secondary outcomes
FP drug extraction fraction (EFR)
Time frame: data collected during each of two study visits, 7-10 days apart
FP/Water EFR
Time frame: data collected during each of two study visits, 7-10 days apart
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mihaela Teodorescu, MD, MS principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone Propionate, Water Mouthwash and EVOOW Mouthwash in people with Asthma, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mihaela Teodorescu, MD, MS (608-256-1901, mt3@medicine.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FP concentration in mouthwashes (ng/mL) (time frame: data collected during each of two study visits, 7-10 days apart). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.