Longitudinal Study of Children With a Chronic Cough and the Impact of Gastroesophageal Reflux
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- No primary outcome measure.
研究概览
简要总结
Cough is both an important physiologic component of lung defense and a cardinal indicator of disease. For those with chronic cough, defined as cough lasting for more than 3 weeks, the differential diagnosis is broad, including self-limited, persistent, and chronic diseases. The success of a given treatment depends upon a proper diagnosis, yet this is often not obvious. Gastroesophageal reflux (GER) has been proposed as one possible etiology of a chronic cough in a number of studies in the adult literature; nevertheless a clear cause and effect remains to be confirmed as there continues to be no gold standard test definitively to identify pathologic GER. Each year, billions of dollars are directed towards diagnosing and treating GER as it relates to adults and children with a chronic cough but without solid proof of effect.
We propose to test the null hypothesis that there is no causative role of GER with regards to the etiology of chronic cough in children. If the null hypothesis proves true, this has important medical and economic ramifications, as it would suggest that treatment of acid reflux for chronic cough in a child is unwarranted. With this conclusion, health care costs would be reduced and children spared inappropriate medication.
详细描述
Introduction
1.1. Cough
Cough is both an important physiologic component of lung defense and a cardinal indicator of disease. It is the second most common reason for medical visits during childhood. The metamorphosis of coughing from a normal to a pathologic event occurs along a gradient that includes frequency, character and duration.1 When considered with the age of the child, each of these characteristics informs decisions about diagnosis and management. For those with chronic cough, defined as cough lasting for more than 3 weeks2, the differential diagnosis is broad, including self-limited, persistent, and chronic diseases. An isolated cough in an otherwise healthy child may be secondary to recurrent viral bronchiolitis, post-infectious etiology, pertussis, cough variant asthma, post-nasal drip, or may be psychogenic in origin. Possible significant underlying causes of cough include cystic fibrosis, primary ciliary dyskinesia, immune deficiencies, chronic bronchitis, retained foreign bodies, airway lesions, tracheomalacia, or extrinsic compression of the airway3. Gastroesophageal reflux (GER) is also included in the differential diagnosis of chronic cough in children.
Specific Aims
- To conduct a randomized , placebo controlled trial to test the null hypothesis that treatment of children with a chronic cough of more than 3 weeks' duration is not effected by medicine designed specifically to treat gastroesophageal reflux (GER) and its extraesophageal manifestations.
- To utilize the "gold standard population"(identified through the protocol outlined in specific aim number 1) to use logistic regression analysis to identify which tests currently employed to identify GER can be employed within a statistically sound predictive model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children 2-18 years of age
- •Male and female children
- •Children of any race or ethnicity
- •Cough lasting longer than three weeks* * If a child has been placed on PPI or other antacid therapy for presumed but not documented extra-esophageal manifestations of GER, then these children will stop taking their antacid therapy after recruitment for the two-week interval between recruitment and the endoscopy, as is the standard protocol at MEEI to allow time for adequate "wash-out" prior to endoscopy and pH probe placement.
排除标准
- •The presence of a chronic respiratory, neurological or gastrointestinal disease and/or anomaly
- •An abnormal barium swallow study indicating vascular compression
- •Allergy with respiratory component,
- •Gross erosive esophagitis defined by EGD findings where patients will automatically be placed on PPI therapy without randomization
研究组 & 干预措施
Proton Pump Inhibitor
To compare the cough reduction rate using either PPI or placebo in children with a chronic cough.
干预措施: Proton Pump Inhibitor (Drug)
Sugar Pill
To compare the cough reduction rate using either PPI or placebo in children with a chronic cough
干预措施: Placebo (Drug)
结局指标
主要结局
No primary outcome measure.
时间窗: No timeframe.
There is no primary outcome measure as this study was not activated. Therefore, no data was collected to measure or analyze.
次要结局
未报告次要终点
