Prevalence of Alpha-1 Antitrypsin Dysfunction in Pulmonary Emphysema
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 190
- Locations
- 2
- Primary Endpoint
- Number of patient with alpha-1 antitrypsin dysfunction
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pulmonary emphysema highlighted by computed tomography
- •Ratio Forced Expiratory Volume in 1 second (FEV1) / Vital Capacity (VC) < 70% measured by lung function test
Exclusion Criteria
- •Hepatic transplant
- •Patient under legal protection
- •Patient not benefiting from the French Health Insurance
Outcomes
Primary Outcomes
Number of patient with alpha-1 antitrypsin dysfunction
Time Frame: 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.
Secondary Outcomes
- 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)