Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fluticasone Propionate, Water Mouthwash, EVOOW Mouthwash.
- Who it may be relevant to
- Registry conditions: Asthma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Proof-of-Concept Study of a Novel Method for Removal of Residual Oropharyngeal Inhaled Corticosteroid Deposits in Asthma
Overview
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
- Drug Fluticasone Propionate
Participants will be administered 1 puff of 220 micrograms FP, via Metered Dose Inhaler, without inhaling into the lungs. - Other Water Mouthwash
Participants will rinse and gargle with 3 consecutive aliquots (20ml each) of either Water (W). - Other EVOOW Mouthwash
Participants will rinse and gargle with 3 consecutive aliquots (20 ml each) of an equal parts EVOO and Water mixture.
Primary outcome measures
- FP concentration in mouthwashes (ng/mL) [Time frame: data collected during each of two study visits, 7-10 days apart]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Wisconsin — Madison
Identifiers
NCT: NCT07664527 · 2022-0874 · Protocol Version 2/2/26 · SMPH | DOM Pulmonary and Crit