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临床试验/NCT03639727
NCT03639727已完成不适用

Cough in Eastern and Central Finland

Kuopio University Hospital2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2018年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
61
试验地点
2
主要终点
Receiver operator characteristic curves of the citric acid and the mannitol aerosol bronchial challenges

研究概览

简要总结

Comparison of citric acid and mannitol cough provocation tests among subjects with chronic cough and healthy volunteers.

详细描述

35 subjects with chronic cough plus 25 subjects without any cough will be asked to participate. The study consists of two visits in the outpatient clinic of Kuopio University Hospital, department of respiratory medicine, 2 - 7 days apart. They will fill in the Leicester Cough Questionnaire and undergo two different cough provocation tests, in random order: Mannitol test and citric acid test. If a chest x-ray has not been taken within 6 months, it will be taken.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
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

入选标准

  • , Chronic cough patients:
  • (both criteria must be fulfilled)
  • presence of current chronic cough (> 8 weeks)
  • Leicester Cough Questionnaire total score < 17
  • Inclusion criteria, healthy volunteers
  • absence of any form of cough

排除标准

  • age < 18 years
  • any disability which would challenge the subject's ability to understand the purpose and methods of the study
  • pregnancy
  • breastfeeding
  • current smoking or ex smoking more than 10 pack years
  • any thoracic x-ray finding indicating urgent mediacal interventions

研究组 & 干预措施

Citric acid aerosol bronchial challenge

Active Comparator

Inhaled citric acid aerosol. This study investigates the diagnostic accuracy of two cough provocation tests, one of which is citric acid aerosol challenge.

干预措施: Citric acid aerosol bronchial challenge (Diagnostic Test)

Mannitol aerosol bronchial challenge

Active Comparator

Inhaled mannitol aerosol. This study investigates the diagnostic accuracy of two cough provocation tests, one of which is mannitol aerosol challenge.

干预措施: Mannitol aerosol bronchial challenge (Diagnostic Test)

结局指标

主要结局

Receiver operator characteristic curves of the citric acid and the mannitol aerosol bronchial challenges

时间窗: Within one week from the start of the study in each individual

Receiver operator characteristic curve describes the ability of the bronchial challenge to separate the cough patients from healthy volunteers

次要结局

  • Leicester Cough Questionnaire total score(The first study day)

研究者

发起方
Kuopio University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Heikki Koskela

Professor

Kuopio University Hospital

研究点 (2)

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