Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Improvement in Dysphagia symptom score
研究概览
简要总结
This study will compare response to treatment of Eosinophilic Esophagitis with montelukast vs standard therapy fluticasone. Investigators hypothesize that montelukast is equally effective in treating symptoms and histology of EoE when compared to fluticasone. The study will be conducted at multiple sites with Medical College of Wisconsin as the coordinating site. After identification and recruitment all patients will be randomized (provider blinded) to one of two medications: montelukast 10mg po qday vs fluticasone 440mcg po bid. Patients will also complete a pretreatment, 6 week therapy and 12 week therapy questionaire. They will then undergo a repeat endoscopy to evaluate endoscopic and histologic response.
详细描述
Eosinophilic esophagitis is an allergic condition of the esophagus with an incidence that is on the rise, and has limited treatment options. Current gold standard of treatment is with topical steroids (swallowed fluticasone). There is preliminary data that oral montelukast may prove to be effective in inducing and maintaining symptomatic along with histologic remission of this disease. Investigators will be comparing the effectiveness of singulair to swallowed fluticasone in inducing and maintaining histologic and symptomatic remission of eosinophilic esophagitis.
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
- Single (Investigator)
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
- •Patients with a confirmed diagnosis of EoE on biopsy
- •with >15 eos per HPF
- •ages >18
- •Both male and Female.
- •Not pregnant
排除标准
- •pregnancy
- •patients receiving ongoing medical therapy for EoE
- •patients who underwent dilation in the last 12 weeks with improvement in symptoms
- •LA grade B or worse erosive esophagitis.
- •age < 18
- •nursing mothers
- •use of prohibited concomitant medications : budesonide-oral compounded liquid, fluticasone or montelukast.
研究组 & 干预措施
Montelukast
patients will receive 10 mg po montelukast daily for 12 weeks.
干预措施: Montelukast (Drug)
Fluticasone
patients will receive 440mcg fluticasone po bid for 12 weeks
干预措施: Fluticasone (Drug)
结局指标
主要结局
Improvement in Dysphagia symptom score
时间窗: 3 month
次要结局
- Improvement in esophageal histology counts of eosinophils/hpf(3 month)