Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate (EVOOW)
2026年8月26日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
20
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Mihaela Teodorescu, MD, MS
- 电话号码：608-256-1901
- 邮箱：mt3@medicine.wisc.edu
学习地点
-
-
Wisconsin
-
Madison、Wisconsin、美国、53792
- University of Wisconsin
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
|
实验性的：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.
|
|
实验性的：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.
|
|
实验性的：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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
FP concentration in mouthwashes (ng/mL)
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
FP drug extraction fraction (EFR)
大体时间：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
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mihaela Teodorescu, MD, MS、UW School of Medicine and Public Health
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2027年7月1日
研究完成 (估计的)
2027年7月1日
研究注册日期
首次提交
2026年6月17日
首先提交符合 QC 标准的
2026年6月17日
首次发布 (实际的)
2026年6月24日
研究记录更新
最后更新发布 (实际的)
2026年8月31日
上次提交的符合 QC 标准的更新
2026年8月26日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 2022-0874
- Protocol Version 2/2/26 (其他标识符：UW Madison)
- SMPH | DOM Pulmonary and Crit (其他标识符：UW Madison)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
是的
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.