Prevalence of Alpha-1 Antitrypsin Dysfunction in Pulmonary Emphysema

Pulmonary Emphysema Clinical Trial

— DysA  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382367
• Other study ID #: 2013.835
• Status: Completed
• Phase: N/A
• First received: December 4, 2014
• Last updated: December 4, 2015
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

Other:
• Blood sampling
Blood tests (Alpha-1 antitrypsin protein measurement, elastase-inhibitory capacity of plasma measurement, phenotypic and genotypic studies)

Locations

Country	Name	City	State
France	Hôpital Louis Pradel - service de pneumologie	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patient with alpha-1 antitrypsin dysfunction	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.	Samples for evaluation of alpha-1 antitrypsin dysfunction will be performed the day of the patient enrollment	No
Secondary	Determination of alpha-1 antitrypsin protein phenotype	The determination of the alpha-1 antitrypsin protein phenotype may highlight genotype variants. The different known phenotypes are: Pi MM, Pi Z; Pi S, Pi SS, Pi SZ, Pi ZZ.	Samples for phenotype analysis will be performed the day of the patient enrollment	No
Secondary	Molecular genotyping of gene coding alpha-1 antitrypsin	For those patients who presented with either a functional or a quantitative dysfunction, we will look for genetic mutations in the gene coding the alpha-1 antitrypsin allowing the identification of specific genotype such as MM, MZ, MS, SS and SZ	Samples for molecular genotyping will be performed the day of the patient enrollment	No