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临床试验/EUCTR2007-004869-18-GB
EUCTR2007-004869-18-GB进行中(未招募)1 期

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 AATD

HB NHS Foundation Trust0 个研究点目标入组 26 人开始时间: 2008年4月4日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
26

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • Three subject groups of individuals over the age of 50 years will be studied.
  • Healthy never smokers age 50-70 years, no evidence of lung disease, FEV1>75% predicted, FEV1/VC>70%, no relevant medical or mental disorder, able to give informed consent.
  • Patients with an emphysema COPD phenotype (and normal alpha 1-antitrypsin phenotype), no other active lung disease, FEV1<75% predicted, FEV1/VC<70%, KCO<80% predicted (or known emphysema on previous CT scan), fewer than two acute exacerbation in the previous 12 months and no recent exacerbations, no smoking history within the preceding 12 months, no other relevant medical or mental disorder, able to give informed consent.
  • Patients with an emphysema COPD phenotype (PiZ alpha 1-antitrypsin phenotype, no other active lung disease, FEV1<75% predicted, FEV1/VC<70%, KCO<80% predicted (or known emphysema on previous CT scan), fewer than two acute exacerbation in the previous 12 months and no recent exacerbations, no smoking history within the preceding 12 months, no other relevant medical or mental disorder, able to give informed consent.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Age <50 or >80
  • Continued smoking
  • Frequent or recent acute exacerbations of COPD
  • Other lung disorder
  • Relevant medical or mental illness

研究者

发起方
HB NHS Foundation Trust

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