Prevalence of Alpha-1 Antitrypsin Dysfunction in Pulmonary Emphysema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Number of patient with alpha-1 antitrypsin dysfunction
研究概览
简要总结
The main objective of this trial is to evaluate the prevalence of alpha-1 antitrypsin quantitative and functional deficiency in an adult French population presenting with pulmonary emphysema. Phenotypic and genotypic studies will be carried whenever quantitative and/or functional deficiency will be displayed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pulmonary emphysema highlighted by computed tomography
- •Ratio Forced Expiratory Volume in 1 second (FEV1) / Vital Capacity (VC) < 70% measured by lung function test
排除标准
- •Hepatic transplant
- •Patient under legal protection
- •Patient not benefiting from the French Health Insurance
结局指标
主要结局
Number of patient with alpha-1 antitrypsin dysfunction
时间窗: Samples for evaluation of alpha-1 antitrypsin dysfunction will be performed the day of the patient enrollment
Alpha-1 antitrypsin protein will be measured either on serum or plasma by standardized immunoassay. The elastase-inhibitory capacity of plasma will be evaluated by a functional test. The anti-elastase dysfunction of alpha-1 antitrypsin will be evaluated using both measurements.
次要结局
- Molecular genotyping of gene coding alpha-1 antitrypsin(Samples for molecular genotyping will be performed the day of the patient enrollment)
- Determination of alpha-1 antitrypsin protein phenotype(Samples for phenotype analysis will be performed the day of the patient enrollment)