Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE): Esophageal Medication Distribution, Treatment Response, and Effect on the Adrenal Axis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Tissue Eosinophil Counts
研究概览
简要总结
The purpose of this study is to conduct a clinical trial of two formulations of budesonide (nebulized/swallowed versus viscous/swallowed) in patients with EoE to determine if medication contact time and distribution in the esophagus relates to treatment response. The investigators will also determine if there is systemic absorption of these topical steroids. The investigators hypothesize that tissue and symptom response will correlate with esophageal medication contact time and distribution, and that significant systemic absorption will not be seen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •New diagnosis of eosinophilic esophagitis (per 2007 consensus guidelines)
排除标准
- •Age < 18
- •Inability to read or understand English
- •Pregnant or nursing women
- •Previous allergic reactions to steroid medications
- •Current use of systemic steroids
研究组 & 干预措施
inhaled/swallowed budesonide
干预措施: inhaled/swallowed budesonide (Drug)
viscous/swallowed budesonide
干预措施: viscous/swallowed budesonide (Drug)
结局指标
主要结局
Tissue Eosinophil Counts
时间窗: 8 weeks
Level of tissue eosinophil counts (measured in number of eosinophils per high-power microscopy field) on esophageal biopsy after treatment
次要结局
- Adrenal Insufficiency(8 weeks)
研究者
Evan Dellon
MD, MPH
University of North Carolina, Chapel Hill