NCT00426283已完成2 期
A Double Blinded, Randomized Trial of Swallowed 1760mcg Fluticasone Propionate Versus Placebo in the Treatment of Eosinophilic Esophagitis
Marc Rothenberg, MD4 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Percentage of Participants Who Attained Remission.
研究概览
简要总结
The purpose of this study is to test the effects (both good and bad) of high dose swallowed fluticasone propionate (Flovent) in subjects with eosinophilic esophagitis (EoE).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent for study by subject, or parent/guardian if subject is a minor. Assent will be obtained from all minors 11 years of age and older.
- •Histological findings on esophageal biopsy to include peak eosinophil density ≥ 24 per high power field (400x) in the proximal or distal esophagus validated by a pathologist at CCHMC.
- •Allergy evaluation including skin-prick testing with multiple food antigens to ensure elimination diet is not indicated.
- •Have undergone a minimum 3 months of elimination diet as indicated by skin-prick testing without detectable resolution by repeat endoscopy with biopsies demonstrating persistent EE OR subject/parental refusal to follow elimination diet. If the subject/parent refuses the elimination diet, they are eligible for this study.
- •Treatment with a proton-pump inhibitor for at least two months (rounded to nearest month) prior to endoscopy OR failure of histological improvement as defined by < 1 eosinophil per HPF after 2 month (rounded to nearest month) trial of proton pump inhibitor documented by prior endoscopy. The PPI must be used prior to endoscopy to rule out the possibility of GERD.
排除标准
- •History of poor tolerance to Fluticasone Propionate (FP), as defined as multiple episodes of oral candidiasis, hypothalamic-pituitary-adrenal axis suppression as evidenced by signs of Cushing syndrome, headaches, or increased respiratory infections during exposure to Flovent
- •Unable to cooperate with use of MDI
- •Pregnant females
- •Concurrent or recent (within 3 months) use of systemic corticosteroids.
- •Unable to swallow medicines (i.e., fed only by gastrostomy tube).
- •Comorbid eosinophilic disorders.
- •Previously treated with swallowed glucocorticoid for EE within 3 months of the screening visit. Nasal glucocorticoids taken for EE are permitted.
研究组 & 干预措施
Flovent 1760 mcg
Experimental
Fluticasone propionate 880 mcg twice daily for 3 months
干预措施: Flovent (Drug)
Placebo
Placebo Comparator
Placebo twice daily for 3 months
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of Participants Who Attained Remission.
时间窗: 3 months
Remission is considered achieved when the highest eosinophil count per high power field (hpf) in all esophageal biopsies is \</= 1 eosinophil/hpf after 3 months of therapy.
次要结局
- Percent of Participants With Abdominal Pain After Therapy(3 months)
- Association of Subject Age, Body Mass Index Z-score, and Allergic Status to Response to Flovent(3 months)
- EoE Score After 3 Months(3 months)
- Association of Compliance With Therapy and Response to Flovent(3 months)
- Percent of Participants With Decreased Cortisol Levels After 3 Months(3 months)
研究者
Marc Rothenberg, MD
Marc Rothenberg, MD, PhD
Children's Hospital Medical Center, Cincinnati
研究点 (4)
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