Evaluating Treatment Response in Laryngo-Pharyngeal Reflux
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Ability of Restech to predict LPR symptom improvement after treatment with Dexlansoprazole.
研究概览
简要总结
Although laryno-pharyngeal reflux (LPR) and gastroesophageal reflux disease (GERD) differ in symptoms and treatment, they are diagnosed by the same standard 24-hour pH monitoring system which measures liquid reflux in the esophagus. The investigators are evaluating a new 24-hour pharyngeal pH monitoring system by Restech which can measure acid exposure in the airway and can be used specifically for LPR diagnosis. The purpose of this study is to determine whether the Restech device is more effective than standard pH monitoring in predicting the response to proton pump inhibitor (PPI) acid suppression therapy using Dexlansoprazole in patients with symptoms and/or manifestations of LPR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age 18 years old or above
- •Have a clinical diagnosis of LPR
- •Able and willing to provide consent
排除标准
- •History of any previous anti-reflux operation or procedure
- •History of pharyngeal or laryngeal surgery
- •History of larngeal or hypolaryngeal neoplasm
- •Allergy or significant adverse reaction to PPI
- •Patient on PPI therapy within 4 weeks prior to enrollment
- •A cumulative history of PPI therapy equal to or greater than 3 months
- •History of noncompliance with medication or study protocols
- •Enrolled in another clinical trial using investigational medications
结局指标
主要结局
Ability of Restech to predict LPR symptom improvement after treatment with Dexlansoprazole.
时间窗: 3 months
Successful LPR symptom improvement will be defined as a 25% improvement in Reflux Symptom Index (RSI)after 3 months of Dexlansoprazole.
次要结局
- Comparison between standard pH data and Restech data (normal vs.abnormal acid exposure, using established normative data values) before and after treatment with Dexlansoprazole.(3 months)
- Correlation between Restech acid exposure events and standard pH monitoring acid exposure events.(3 months)
- Laryngoscopic findings pre and post Dexlansoprazole treatment.(3 months)
- Differences between RSI and general GERD symptom questionnaire scores on and off Dexlansoprazole.(3 months)
- Correlation of RSI and general GERD symptom questionnaire scores with Restecha dn standard pH values.(3 months)