Which Supraesophageal Reflux Symptoms Reliably Respond to PPI Therapy: A Large Simple Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- To determine which symptom(s) are predictive of SER based on a complete response to PPI therapy
研究概览
简要总结
The investigators hypothesize that persons with the particular cluster of symptoms that are due to supraesophageal reflux (SER) will have complete resolution of those symptoms with adequate acid suppression when a PPI is administered for 6 months.
详细描述
Estimates suggest that up to 50% of Voice Clinic patients and 10% of ENT and Pulmonology outpatients seek medical care for chronic laryngopharyngeal symptoms resulting from supraesophageal reflux (SER). While many anecdotal and uncontrolled studies have shown significant clinical benefit with Proton Pump Inhibitors (PPIs), this conclusion has not been supported in small, randomized, placebo-controlled studies. The recent negative Vaezi trial (unpublished) was limited by bias introduced in the patient enrollment process due to reliance on physician diagnosis of SER. This bias became clear during conduction of the Supraesophageal Reflux Questionnaire (SRQ) Validation Study (Mayo, in press), which demonstrated that Otolaryngologists vary in their threshold for considering the diagnosis of SER. This project aims to remove selection bias from the study design.
Hypotheses/Questions: Our underlying assumptions are as follows: SER is due to the passage of gastric contents into the esophagus; and with adequate acid suppression provided by a PPI, there is less overall volume available to reflux, which should improve SER. We hypothesize that persons with the particular cluster of symptoms that are due to SER will have complete resolution of those symptoms with adequate acid suppression when PPI is administered for an adequate duration of time.
Primary Aim:
- To determine which symptom(s) (chronic cough, hoarseness, sore throat, globus sensation, or throat clearing) are completely ameliorated with PPI therapy and hence reflective of SER.
Secondary Aims:
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
- Triple (Participant, Care Provider, 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
- 是
入选标准
- •Primary complaint includes one of the following symptoms: chronic cough (dry, hacking, or nocturnal), hoarseness, sore throat, globus sensation, or throat clearing. These symptoms will be identified by a yes response to SRQ (Appendix 7) items 2, 3, 4, 5, 6, and
- •Furthermore, symptom(s) must be chronic (present for at least 1 month), and recurrent (at least twice per week). These criteria correspond to SRQ columns on page 3-
- •The first column asks: When in your life did you first notice this symptom? A response with either number 2, 3, 4, or 5 meets criteria for chronic. The second column asks: How frequently have you noticed the symptom? A response with either number 3, 4, or 5 meets criteria for recurrent.
排除标准
- •History of head and neck cancer/radiation/surgery (SRQ items 15, 16, 17)
- •History of esophagus/stomach surgery (SRQ item 22)
- •Peptic or duodenal ulcer disease; stomach or gastric ulcer disease; history of esophageal stricture, or Barrett's esophagus, or esophagitis, or tumor of the esophagus or stomach (SRQ item 23 and review of electronic surgical records of Mayo Clinic patients)
- •Presence of alarm symptoms (hemoptysis, unexplained loss of 10 or more pounds in the past 3 months), obtained from Appendix 5 for Community Subjects, medical record for clinic subjects. History of dysphagia, defined as a yes answer to SRQ item
- •PPI use within 4 weeks, obtained from Appendix 5 for Community Subjects, medical record for clinic subjects
- •Use of warfarin or digoxin, obtained from Appendix 5 for Community Subjects, medical record for clinic subjects
- •Pregnancy at the time of enrollment, based on urine pregnancy test
- •Inability to understand or read English at a 6th grade level
- •Residence outside of the United States of America (USA)
- •Age younger than 18 years old
研究组 & 干预措施
Sugar pill
干预措施: Sugar Pill (Drug)
Active Comparator
干预措施: Nexium (Drug)
结局指标
主要结局
To determine which symptom(s) are predictive of SER based on a complete response to PPI therapy
时间窗: 1 month
次要结局
- To determine which symptoms demonstrate partial response with PPI therapy(1 month)
- To determine which features of a patient's history are predictive of a positive response to PPI therapy(1 month)
- To determine which features of a patient's history are predictive of a lack of response to PPI therapy(1 month)
- To develop a scoring system for the Supraesophageal Reflux Questionnaire (SRQ) that would predict a diagnosis of SER(1 year)