跳至主要内容
临床试验/NCT00523367
NCT00523367终止不适用

COPD Patients Diagnosed With Gastro Esophageal Reflux Disease Have Decreased Rates of COPD Exacerbations After Treatment With High Dose Proton Pump Inhibitor Therapy (Esomeprazole or Lansoprazole)

University of Florida2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2007年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
25
试验地点
2
主要终点
Number of Participants With Gastro Esophageal Reflux Disease One Year After Treatment.

研究概览

简要总结

The purpose of this study is to determine which COPD patients have GERD and if COPD patients with GERD treated with high dose lansoprazole for 1 year decreases the frequency of COPD exacerbations compared to the previous year without treatment.

详细描述

Gastroesophageal reflux disease (GERD) is a common esophageal disorder with 40% of the US adult population experiencing symptoms monthly. Pulmonary diseases associated with GERD may include pneumonia, pulmonary fibrosis, asthma, or chronic bronchitis. The latter may be a manifestation of chronic obstructive pulmonary disease (COPD), suggesting GERD as a risk factor for acute exacerbation of COPD. Acute exacerbations of COPD are a major cause of morbidity and mortality in patients with the disease. Recent work suggests that COPD patients with a minimum of weekly reflux symptoms have an increased number of COPD exacerbations that those who are either asymptomatic or have GERD symptoms less than once a week. On this basis, we theorized that in patients with COPD, who also have gastro esophageal reflux disease are at increase risk for acute exacerbations of COPD. To test this question, we will determine which COPD patients have GERD by 24 hour pH testing, treat their GERD with esomeprazole or lansoprazole for 1 year, and compare the number of COPD exacerbations during the treatment period to the previous year.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of COPD
  • forced expiratory volume/forced vital capacity ratio (FEV1/FVC) of < 70% on pulmonary function testing
  • age > 40 years
  • >20 pack year history of smoking

排除标准

  • presence of the following disorders: respiratory disorders other than COPD, known esophageal disease such as cancer, achalasia, stricture, active peptic ulcer disease, Zollinger-Ellison syndrome, mastocytosis, scleroderma, or current abuse of alcohol defined as greater than three alcoholic drinks per day.

结局指标

主要结局

Number of Participants With Gastro Esophageal Reflux Disease One Year After Treatment.

时间窗: 1 year

The number of participants who have Gastro Esophageal Reflux Disease after one year of treatment.

次要结局

  • COPD/GERD Patients Treated With High Dose Esomeprazole(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验