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临床试验/NCT02069054
NCT02069054已完成不适用

Relationship Between Airway Inflammation and Remodeling in Asthma and COPD Patients.

Medical University of Warsaw1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
Inflammatory markers

研究概览

简要总结

Asthma and chronic obstructive pulmonary disease (COPD) are inflammatory airway diseases. Although the clinical features of asthma and COPD may be similar, the pathogenesis of these diseases differs in many aspects.

The aim of this study is:

  • to evaluate airway inflammation in asthma and COPD,
  • to evaluate airway remodeling in asthma and COPD as compared to healthy subjects,
  • to assess the relationship between markers of airway inflammation and airway remodeling in asthma and COPD patients.

Material and methods:

  • mild to moderate asthma patients diagnosed in accordance with Global Initiative for Asthma (GINA) guidelines,
  • mild to moderate COPD patients diagnosed in accordance with Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines,
  • healthy subjects as controls.

Airway inflammation is assessed in induced sputum (IS), exhaled breath condensate (EBC), bronchoalveolar lavage fluid (BALF) and specimens from endobronchial forceps biopsy. Airway wall thickness is evaluated in high resolution computed tomography (HRCT), endobronchial ultrasound (EBUS) and basement membrane thickness (BMT) in biopsy specimens.

We plan to compare airway inflammation and features of airway remodeling in asthma and COPD patients.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • a clinical diagnosis of asthma or COPD in accordance with GINA or GOLD, respectively
  • control group - healthy volunteers without any history of lung disease

排除标准

  • age below 18 years
  • exacerbation in the past 6 weeks
  • inhaled corticosteroid therapy at least 6 weeks prior to study enrollment
  • significant co-morbidities

结局指标

主要结局

Inflammatory markers

时间窗: Approximately 1-2 months after completion of study procedures (bronchoscopy, induced sputum, etc.) in all patients (probably January 2015)

Inflammatory markers in exhaled breath condensate and induced sputum in healthy subjects, COPD and asthma patients.

Airway wall thickness

时间窗: Approximately 1-2 months after completion of study procedures (bronchoscopy with EBUS, HRCT) in all patients (probably January 2015)

Airway wall thickness in healthy subject, COPD and asthma patients assessed by HRCT and EBUS

次要结局

未报告次要终点

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Sponsor

研究点 (1)

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