Comparison of Aerosolized Swallowed Fluticasone to Esomeprazole for the Treatment of Eosinophilic Esophagitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Number of Participants Who Responded
研究概览
简要总结
The purpose of this study is to assess the clinical efficacy of proton pump inhibitors in comparison to aerosolized swallowed steroids for the treatment of eosinophilic esophagitis (EE). EE is an increasingly recognized disorder that has been associated with dysphagia and food impaction. The presence of anatomical abnormalities in the esophagus such as longitudinal furrows, corrugated rings and a narrow caliber esophagus with friable mucosa are classic endoscopic findings. Diagnosis is established with the histologic finding of large numbers (> 15) of eosinophils per high power field. The underlying pathologic mechanism remains poorly understood but food allergies and aeroallergens have been implicated. It is well known that gastroesophageal reflux disease (GERD) may cause esophageal eosinophilia, but it is unclear whether a complex relationship exists between GERD and EE, as recent data suggests. Furthermore, a large number of patients with clinical presentations and endoscopic findings highly suggestive of EE which is confirmed on histology are responding favorably to proton pump inhibitors.
The aims of the study are to (1) compare the clinical efficacy of aerosolized swallowed Fluticasone to Esomeprazole for the treatment of eosinophilic esophagitis, (2) determine whether proton pump inhibitors are effective in the treatment of eosinophilic esophagitis, (3) determine the number of patients with eosinophilic esophagitis that have coexisting gastroesophageal reflux disease, and (4) correlate change in eosinophil count to improvement in symptoms before and after therapy.
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
- 否
入选标准
- •Patients with an established diagnosis of EE defined as > 20 eosinophils/HPF in the setting of dysphagia or food impaction.
- •Males and females age > 18 years of age.
- •Ability to undergo ambulatory pH monitoring.
- •DEERS (Defense Enrollment Eligibility Reporting System) eligible.
- •Willingness to take a one month holiday from a PPI or steroids if they have been prescribed this prior to enrollment.
- •Willingness to participate and have additional biopsies taken during endoscopy and answer a questionnaire.
排除标准
- •Patients < 18 years of age.
- •Inability to give consent.
- •Inability to undergo endoscopy or contraindications to endoscopy. Any medical condition or disorder (including drug allergies), which would preclude the use of conscious sedation or the ability to tolerate upper endoscopy.
- •Contraindications to proton pump inhibitors or steroids.
- •Inability to accurately fill out a short questionnaire.
- •Pregnant females. A urine beta human chorionic gonadotropin (BHCG) prior to endoscopy will be offered to all female patients of child bearing potential (exceptions include post-menopausal, hysterectomy or bilateral tubal ligation). Positive BHCG results will prevent enrollment.
- •Known coagulation abnormalities, thrombocytopenia and patients on coumadin.
研究组 & 干预措施
Swallowed fluticasone
干预措施: Swallowed fluticasone (Drug)
Esomeprazole
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Number of Participants Who Responded
时间窗: 8 weeks
Histologic resolution of esophageal eosinophilia. Response is defined as achieving \< 7 eosinophils/high power field in both the proximal and distal esophagus.
次要结局
- Symptom Score(8 weeks)
- Endoscopic Change(8 weeks)
研究者
Fouad J. Moawad
Principal Investigator
Walter Reed Army Medical Center