Development and Validation of Test for Gastro-esophageal Reflux and Aspiration
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Total cromolyn in urine collected overnight
研究概览
简要总结
The overall purpose of this project is to develop and validate a simple, non-invasive method to detect aspiration of gastro-intestinal fluid into the respiratory tract. In the inpatient setting, the investigators will compare the quantity of cromolyn detected in urine collected overnight after 4 ingestions (at 2h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium, by 5 healthy control subjects and 5 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently undergone lung transplantation) with clinical and laboratory evidence of GER (gastroesophageal reflux) with microaspiration. In the outpatient setting, the investigators will compare the quantity of cromolyn detected in urine collected overnight after 1 ingestions (at 4h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium, by 10 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently undergone lung transplantation) with clinical and laboratory evidence of GER (gastroesophageal reflux) with microaspiration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants
- •Adult non-smokers
- •Females only - negative urine pregnancy test
- •Lung transplant patients
- •Adult patients awaiting (or recently undergone) - lung transplant
- •Evidence of gastro-esophageal reflux with probable recurrent aspiration
- •Females only - negative urine pregnancy test
- •Idiopathic pulmonary fibrosis patients
- •Adult patients currently enrolled in on-going University of California, San Francisco study of prevalence of recurrent GER with aspiration in idiopathic pulmonary fibrosis
- •Evidence of gastro-esophageal reflux with probable recurrent aspiration
- •Females only - negative urine pregnancy test
- •Exclusion criteria:
- •Healthy participants
- •History of dysphagia
- •Recurrent cough
- •Pneumonia after childhood
- •Sleep impairment
- •Use of drugs or alcohol impairing consciousness
- •Impaired gag reflex on physical examination
- •Any other significant medical illness (e.g., morbid obesity, diabetes, neurologic disease, etc.) that in the opinion of the investigator could affect the clinical features measured, responses to the therapies to be given in this study, or risks of participating in the study
- •Greater than 5 pack years lifetime smoking history
- •History of intolerance or allergy to cromolyn sodium
- •Lung transplant patients
- •History of intolerance or allergy to cromolyn sodium
- •History of Nissen fundoplication
- •IPF patients
- •History of intolerance or allergy to cromolyn sodium
- •History of Nissen fundoplication
排除标准
- 未提供
研究组 & 干预措施
Gastrocrom
4 ingestions (at 2h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium (inpatient) OR 2 ingestions (at 4h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium (outpatient)
干预措施: Cromolyn Sodium (Drug)
结局指标
主要结局
Total cromolyn in urine collected overnight
时间窗: Collected overnight (6 hours)
次要结局
未报告次要终点