Effectiveness of Cycling of Topical Steroid Therapy in Maintaining Clinical and Histologic Remission in Eosinophilic Esophagitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Percent of Patients in Remission at One Year as Measured by EGD
研究概览
简要总结
The purpose of our research study is to assess whether patients with EoE who have achieved control of their disease on topical Fluticasone or Budesonide are able to cycle or take breaks from their treatment with continued remission of their EoE. There will be 30 participants enrolled in this study. There will be 15 patients who will stay on steroid therapy every day and 15 patients who will cycle their steroid therapy on and off to help us compare the two groups. The cycling group will cycle their steroid therapy in a three-months on three-months off fashion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients between 4-18 years of age with EoE followed by the Division of Pediatric Gastroenterology, Hepatology and Nutrition at Rainbow Babies and Children's Hospital
- •Patients who are currently on treatment with topical corticosteroids and scheduled for an upcoming endoscopy as part of their routine clinical care (to be used as EGD1) within 3 months of enrollment date
- •Patients who have achieved documented clinical and endoscopic remission using topical steroids as evidenced by EGD
排除标准
- •Patients who are not responsive to topical corticosteroid treatment for their EoE as evidenced by failure to obtain clinical or endoscopic remission on any pervious screening EGD
- •Patients less than 4 years of age and older than 18 years of age at the time of recruitment
- •Patients with history of or current diagnosis of esophageal strictures
研究组 & 干预措施
Intervention
Participants in this arm will cycle their topical steroid therapy in a three-months on three-months off fashion
干预措施: Fluticasone Propionate (Drug)
Intervention
Participants in this arm will cycle their topical steroid therapy in a three-months on three-months off fashion
干预措施: Budesonide (Drug)
结局指标
主要结局
Percent of Patients in Remission at One Year as Measured by EGD
时间窗: up to one year
The outcome measure is the number of participants who maintained remission (less than or equal to 15 eosinophils per high powered field in esophageal biopsies) for one year after demonstration of a therapeutic effect of topical steroid therapy.
次要结局
- Number of Patients Who Report Adverse Events as Measured by Patient Report(up to 12 months)
- Number of Patients Who Develop Subclinical Adrenal Insufficiency as Measured by Blood Work(up to 12 months)
研究者
Thomas J Sferra, MD
Chief of Pediatric Gastroenterology Hepatology and Nutrition
University Hospitals Cleveland Medical Center