跳至主要内容
临床试验/NCT01888549
NCT01888549已完成不适用

Efficacy of Proton Pump Inhibitor for Chronic Cough Caused by Gastroesophageal Reflux; Double-blind, Placebo-controlled, Randomized Clinical Trial

Yonsei University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
change in LCQ score and cough VAS, comparing PPI-treated group to placebo

研究概览

简要总结

Efficacy of proton pump inhibitor for chronic cough caused by gastroesophageal reflux; double-blind, placebo-controlled, randomized clinical trial

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
Double (Participant, Investigator)

入排标准

年龄范围
19 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ages of 18 and 70 years had chronic cough of >8 weeks in duration

排除标准

  • abnormal chest X ray, PNS view
  • previous surgical or endoscopic antireflux procedure
  • previous aerodigestive malignancy or Barrett's oesophagus
  • current smokers or ex-smok-ers (defined as those who quit smoking <3 months prior to study enrolment or those who have quit, but have a 20 pack year smoking history)
  • Malignancy History (lung cancer, esophageal cancer etc.)
  • upper respiratory infection within 8 weeks of study enrolment
  • currently using a PPI, H2 blocker, beta-blocker, angiotensin-converting enzyme inhibitor, corticosteroid, methylxanthine, inhaled beta-agonist, anti-inflammatory agent or anticholinesterase drug at time of enrolment

研究组 & 干预措施

arm1-High dose PPI

Experimental

干预措施: High-dose PPI (Drug)

arm2-standard dose PPI

Active Comparator

干预措施: standard PPI (Drug)

arm3-placebo

Placebo Comparator

Esomeprazole placebo

干预措施: placebo (Drug)

结局指标

主要结局

change in LCQ score and cough VAS, comparing PPI-treated group to placebo

时间窗: change in LCQ score after 4 weeks and 8 weeks

次要结局

  • change in LCQ score and cough VAS, comparing PPI-treated group to placebo(change in cough VAS after 4weeks and 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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