NCT01419158已完成不适用
Targeted Detection of Alpha-1 Antitrypsin Deficiency in Patients Referred for Pulmonary Function Testing
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,457
- 试验地点
- 19
研究概览
简要总结
Alpha-1 antitrypsin deficiency (AATD) is considered a rare genetic cause of chronic obstructive pulmonary disease (COPD) and liver disease. Recent data has suggested that AATD is not as rare as originally thought and undetected AATD may account for COPD in some patients. This study was designed to evaluate the frequency of undetected AATD in a population reporting to academic pulmonary function testing facilities who meet criteria for the diagnosis of COPD. All individuals meeting GOLD criteria for COPD will be consented and offered free testing for AATD. The results will help identify the percent of those with COPD who have undetected AATD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults at least 18 years of age able to understand and consent to the procedures of this protocol.
- •All races and ethnicities will be considered for this study.
- •Post-bronchodilator values for pulmonary function tests on the day of enrollment with an FEV1 < 80% of predicted and FEV1/FVC < 70% (at least GOLD stage II).
- •Subjects who have been tested for Alpha-1 in the past but do not know their genotype or phenotype may be included in this study.
- •Note: For the inclusion criteria the investigators will use the patient's GOLD status, based on percent predicted (FEV1 < 80% of predicted); however, after sending the absolute value of FEV1 to the Data Coordinating Center (DCC) the DCC will calculate the percent predicted using a standardized formula (NHANES III). For sites that do not use this predicted formula, the results obtained at the DCC may differ from those used for subject enrollment. (For example, a subject found to have an FEV1 of <80% at the study site could have an FEV1 > 80% when the DCC recalculates it). Enrollment will be based on the percent predicted at each study site. If necessary, the data from this small number of outliers will be analyzed separately.
排除标准
- •Subjects in whom post-bronchodilator spirometry is not performed.
- •Subjects whose ordering physician has specifically requested that his patients not be considered for enrollment.
- •Patients who have been tested for Alpha-1 in the past and know their genotype or phenotype.
研究者
研究点 (19)
Loading locations...
相似试验
进行中（未招募）
不适用
Alpha-1 Antitrypsin Disease Cohort: Longitudinal Biomarker Study of DiseaseAlpha 1-Antitrypsin DeficiencyGenetic DiseaseNCT05297812Columbia University286
招募中
不适用
PiMZ Longitudinal Cohort (PiMZ Logic)Alpha 1-Antitrypsin DeficiencyEmphysema or COPDNCT06505603Columbia University80
已完成
不适用
Alpha1-antitrypsin deficiency, respiratory infections and airway inflammation: the role of epithelial cellsCOPD10006436emphysemaNL-OMON35677eids Universitair Medisch Centrum60
已完成
不适用
The Use of High Resolution Chest Computed Tomography in Alpha-1 Antitrypsin DeficiencyAlpha-1 Antitrypsin DeficiencyNCT00532805Medical University of South Carolina49
招募中
不适用
Czech AATD RegistryAlpha-1-antitrypsin DeficiencyNCT05178277Thomayer University Hospital300