A Phase II, Randomized, Placebo-controlled Study Evaluating the Efficacy of Antihistamines in the Treatment of Eosinophilic Esophagitis (the ATEE Study)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
Researchers are assessing the safety and effectiveness of antihistamines in the treatment of eosinophilic esophagitis.
详细描述
The purpose of this research is to determine if antihistamines are safe and effective for the treatment of eosinophilic esophagitis. Antihistamines are frequently used for the treatment of gastroesophageal reflux disease and allergic disorders, and we hypothesize they will be effective in the treatment of eosinophilic esophagitis as well. The two antihistamines used in this study are loratadine and famotidine.
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 (Participant)
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
- •Patients over the age of 18, male and female.
- •Patients who carry the diagnosis of Eosinophilic Esophagitis (EoE) based on esophageal biopsies obtained within 6 months prior to enrollment (>15 eosinophils per hpf on at least 2 esophageal levels)
- •Subjects must be able to give appropriate informed consent
排除标准
- •Not willing or able to sign consent.
- •Patients who have used topical or systemic corticosteroid therapy for any reason in the previous 6 weeks.
- •Patients who have been treated with acid-suppressing medications (PPI or H2 receptor antagonists) in the previous 6 weeks.
- •Patients on immunosuppressive or immunomodulating medications in the previous 6 weeks.
- •Patients with known allergies or hypersensitivity to anti-histamines.
- •Patients who have contraindications to the procurement of esophageal biopsies including patients who have known bleeding disorders, a history of bleeding diathesis, or who are currently using warfarin or clopidogrel.
- •Patients who have a contraindication to the performance of an esophagogastroduodenoscopy (EGD) including previous cardiopulmonary arrest during an endoscopic procedure.
- •Patients who are pregnant.
研究组 & 干预措施
Treatment Group
Participants receive Famotidine 40 mg tab twice daily by mouth and Loratadine 10 mg tab once daily by mouth for 12 weeks.
干预措施: Famotidine (Drug)
Treatment Group
Participants receive Famotidine 40 mg tab twice daily by mouth and Loratadine 10 mg tab once daily by mouth for 12 weeks.
干预措施: Loratadine (Drug)
Placebo Group
Participants receive Famotidine placebo tablet matching Famotidine orally twice daily for 12 weeks, and Loratadine placebo tablet matching Loratadine orally daily for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse Events
时间窗: 12 weeks
Number of adverse events reported
Change in Maximum Eosinophil Count
时间窗: 12 weeks
Calculated by maximum eosinophils per esophagogastroduodenoscopy (EGD) high-power field (eos/hpf) after therapy with antihistamines. As measured by the percentage of change in maximum eosinophil count from baseline to 12 weeks.
次要结局
- Change in Symptoms of Eosinophilic Esophagitis, as Measured by Dysphagia Symptom Questionnaire(12 weeks)
- Change in Endoscopic Response, as Measured by the Endoscopic Reference Score(12 weeks)
- Change in Histologic Response(12 weeks)