NCT03812575已完成不适用
The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年1月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Fractionated exhaled nitric oxide (FeNO) level
研究概览
简要总结
The purpose of the study is to evaluate of the relationships between fractionated exhaled nitric oxide, disease activity, and symptom severity in patients with eosinophilic esophagitis compared to those without eosinophilic esophagitis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patient who will undergo esophagogastroduodenoscopy with biopsies at Children's Memorial Hermann Hospital, as part of the standard of care in the evaluation of EoE
- •Able to perform the single-breath exhalation for the hand-held analyzer, NIOX MINO (Aerocrine, Sweden)
- •Signed informed consent by a parent or legal guardian
- •Signed assent form by the child/adolescent subjects 7-18 years of age
排除标准
- •Past medical history of asthma, allergic rhinitis, IBD, parasitic infection, hay fever and any exposure to smoking (including secondhand smoke) because these disorders are known to affect the FeNO levels
- •Active respiratory tract infections at the time of FeNO evaluation because this can affect the result of the FeNO as well
- •Asthma questionnaire and/or Spirometry test consistent with asthma
结局指标
主要结局
Fractionated exhaled nitric oxide (FeNO) level
时间窗: at about 4-12 weeks (day of second endoscopy)
The FeNO measurement will be performed using a hand-held analyzer, the NIOX MINO (Aerocrine, Sweden). During this non-invasive procedure the patient is asked to perform a 4-6 second single-breath exhalation into the NIOX MINO, which measures FeNO in 100s with an electrochemical sensor.
次要结局
- Serum eosinophil counts as assessed by complete blood count (CBC)(baseline (day of first endoscopy))
- Esophageal eosinophil counts as assessed by biopsy(at about 4-12 weeks (day of second endoscopy))
- Disease-related symptoms severity as assessed by Pediatric Eosinophilic Esophagitis Symptom Severity (PEESS) version 2.0 questionnaire(at about 4-12 weeks (day of second endoscopy))
研究者
Tu Thanh Mai
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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