A Randomized Placebo-Controlled Trial of Montelukast in Maintenance Therapy of Asymptomatic Eosinophilic Esophagitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- evaluate effectiveness of oral montelukast in treatment of EE.
研究概览
简要总结
Evaluate clinical effectiveness of oral montelukast compared to placebo on prevention of dysphagia and food impaction in patients with EE.
Also evaluate tolerance and safety of oral montelukast in treatment of EE.
详细描述
We will randomize in a double blind manner 60 consecutive consenting patients being evaluated at the three Mayo Clinic Medical Centers with EE to montelukast 20mg daily or placebo daily for six months? time. Patients will be in remission after treatment with topical fluticasone therapy before enrollment. Patients will fill out a validated dysphagia and side effect questionnaire before, during, and at the end of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •> 14 eosinophils / hpf on biopsies from mid esophagus within the 6 months.
- •Abnormal dysphagia questionnaire (Question 1a yes, question 1c >/= mild and question 2 >/= less than once a week) prior to topical steroid treatment. This questionnaire has recently been validated.
- •Normal dysphagia questionnaire after topical steroid treatment (Having an answer of no to question 1a: Have you had trouble swallowing, not associated with other cold symptoms? over the past two weeks since having completed the swallowed steroid treatment).
排除标准
- 未提供
研究组 & 干预措施
Drug
20 mg montelukast daily for 6 months
干预措施: Montelukast/ Singulair (Drug)
Placebo
20 mg daily placebo
干预措施: Placebo (Drug)
结局指标
主要结局
evaluate effectiveness of oral montelukast in treatment of EE.
时间窗: 6 months
次要结局
- evaluate safety of montelukast in eosinophilic esophagitis(6 months)
研究者
Jeffrey A Alexander
Principal Investigator
Mayo Clinic