Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate (EVOOW)
26. august 2026 oppdatert av: University of Wisconsin, Madison
A Proof-of-Concept Study of a Novel Method for Removal of Residual Oropharyngeal Inhaled Corticosteroid Deposits in Asthma
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
20
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Mihaela Teodorescu, MD, MS
- Telefonnummer: 608-256-1901
- E-post: mt3@medicine.wisc.edu
Studiesteder
-
-
Wisconsin
-
Madison, Wisconsin, Forente stater, 53792
- University of Wisconsin
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Asthma: Water Then EVOOW
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.
|
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.
|
|
Eksperimentell: Asthma: EVOOW Then Water
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.
|
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.
|
|
Eksperimentell: Healthy Control: Water Then EVOOW
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.
|
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.
|
|
Eksperimentell: Healthy Control: EVOOW Then Water
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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
FP concentration in mouthwashes (ng/mL)
Tidsramme: 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.
|
data collected during each of two study visits, 7-10 days apart
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
FP drug extraction fraction (EFR)
Tidsramme: 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. |
data collected during each of two study visits, 7-10 days apart
|
|
FP/Water EFR
Tidsramme: 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. |
data collected during each of two study visits, 7-10 days apart
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Mihaela Teodorescu, MD, MS, UW School of Medicine and Public Health
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. juli 2027
Studiet fullført (Antatt)
1. juli 2027
Datoer for studieregistrering
Først innsendt
17. juni 2026
Først innsendt som oppfylte QC-kriteriene
17. juni 2026
Først lagt ut (Faktiske)
24. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
31. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2022-0874
- Protocol Version 2/2/26 (Annen identifikator: UW Madison)
- SMPH | DOM Pulmonary and Crit (Annen identifikator: UW Madison)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Ja
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