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临床试验/ISRCTN80875207
ISRCTN80875207已完成不适用

Evaluation of the relative severity of pulmonary neutrophilic inflammation and therapeutic modification with intravenous prolastin by means of 18 fluoro-2-deoxyglucose (18FDG) positron emission tomography (PET)/computerised tomography (CT) scanning in subjects with usual chronic obstructive pulmonary disease (COPD) and alpha 1-antitrypsin deficiency

niversity Hospitals Birmingham NHS Foundation Trust (UK)0 个研究点目标入组 30 人开始时间: 2008年10月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • Healthy controls:
  • 1. Healthy subjects
  • 2. Both males and females, aged 50 - 70 years
  • 3. Those who have never smoked regularly for more than 3 months
  • 4. No evidence of lung disease
  • 5. Forced expiratory volume in 1 second (FEV1) greater than 75% predicted, FEV1/forced vital capacity (FVC) greater than 70% predicted
  • 6. No relevant medical or mental disorder
  • 7. Able to give informed consent
  • COPD patients:
  • 1. Emphysema with no other active lung disease
  • 2. FEV1 less than 75% predicted, FEV1/FVC less than 70% predicted, carbon monoxide transfer coefficient (KCO) less than 80% predicted (or known emphysema on previous CT scan)
  • 3. Fewer than two acute exacerbations in the previous 12 months and no recent exacerbations (within 2 months)
  • 4. No other relvant medical or mental disorder
  • 5. Able to give informed consent
  • Patients with alpha 1-antitrypsin deficiency:
  • 1. PiZ phenotype
  • 2. Emphysema with no other active lung disease
  • 3. FEV1 less than 75% predicted, FEV1/FVC less than 70% predicted, KCO less than 80% predicted (or known emphysema on previous CT scan)
  • 4. Fewer than two acute exacerbations in the previous 12 months and no recent exacerbations (within 2 months)
  • 5. No other relvant medical or mental disorder
  • 6. Able to give informed consent

排除标准

  • Does not comply with the above inclusion criteria

研究者

发起方
niversity Hospitals Birmingham NHS Foundation Trust (UK)

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Evaluation of the relative severity of pulmonary neutrophilic inflammation and therapeutic modification with IV Prolastin by means of 18 FDG PET/CT scanning in subjects with alpha1-antitrypsin deficiency. - ECLIPSE AATDThe medical condition is emphysema and will be investigated in subjects with alpha 1-antitrypsin deficiency.MedDRA version: 9.1 Level: LLT Classification code 10001811 Term: Alpha-1 proteinase inhibitor deficiencyMedDRA version: 9.1 Level: LLT Classification code 10014563 Term: Emphysema pulmonaryMedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPDMedDRA version: 9.1 Level: LLT Classification code 10006458 Term: Bronchitis chronic
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