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Prevalence of Alpha-1 Antitrypsin Dysfunction in Pulmonary Emphysema (DysA)

Primary Purpose

Pulmonary Emphysema

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Emphysema

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Louis Pradel - service de pneumologie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pulmonary emphysema

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
December 4, 2014
Last Updated
December 4, 2015
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02382367
Brief Title
Prevalence of Alpha-1 Antitrypsin Dysfunction in Pulmonary Emphysema
Acronym
DysA
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Emphysema

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary emphysema
Arm Type
Experimental
Arm Description
Blood tests (Alpha-1 antitrypsin protein measurement, elastase-inhibitory capacity of plasma measurement, phenotypic and genotypic studies)
Intervention Type
Other
Intervention Name(s)
Blood sampling
Intervention Description
Blood tests (Alpha-1 antitrypsin protein measurement, elastase-inhibitory capacity of plasma measurement, phenotypic and genotypic studies)
Primary Outcome Measure Information:
Title
Number of patient with alpha-1 antitrypsin dysfunction
Description
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.
Time Frame
Samples for evaluation of alpha-1 antitrypsin dysfunction will be performed the day of the patient enrollment
Secondary Outcome Measure Information:
Title
Determination of alpha-1 antitrypsin protein phenotype
Description
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.
Time Frame
Samples for phenotype analysis will be performed the day of the patient enrollment
Title
Molecular genotyping of gene coding alpha-1 antitrypsin
Description
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
Time Frame
Samples for molecular genotyping will be performed the day of the patient enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hôpital Louis Pradel - service de pneumologie
City
Bron
ZIP/Postal Code
69677
Country
France

12. IPD Sharing Statement

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Prevalence of Alpha-1 Antitrypsin Dysfunction in Pulmonary Emphysema

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