A Proof-of-Concept Study of a Novel Method for Removal of Residual Oropharyngeal Inhaled Corticosteroid Deposits in Asthma
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- FP concentration in mouthwashes (ng/mL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: EVOOW Mouthwash (Other)
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.
干预措施: EVOOW Mouthwash (Other)
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.
干预措施: EVOOW Mouthwash (Other)
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.
干预措施: Fluticasone Propionate (Drug)
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.
干预措施: Water Mouthwash (Other)
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.
干预措施: Fluticasone Propionate (Drug)
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.
干预措施: EVOOW Mouthwash (Other)
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.
干预措施: Water Mouthwash (Other)
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.
干预措施: Fluticasone Propionate (Drug)
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.
干预措施: Fluticasone Propionate (Drug)
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.
干预措施: Water Mouthwash (Other)
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.
干预措施: Water Mouthwash (Other)
结局指标
主要结局
FP concentration in mouthwashes (ng/mL)
时间窗: 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.
次要结局
- FP drug extraction fraction (EFR)(data collected during each of two study visits, 7-10 days apart)
- FP/Water EFR(data collected during each of two study visits, 7-10 days apart)