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Trial record 31 of 135 for:    Emphysema: Clinical Trials

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

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ClinicalTrials.gov Identifier: NCT02382367
Recruitment Status : Completed
First Posted : March 6, 2015
Last Update Posted : December 7, 2015
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment Phase
Pulmonary Emphysema Other: Blood sampling Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : December 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arm Intervention/treatment
Experimental: Pulmonary emphysema
Blood tests (Alpha-1 antitrypsin protein measurement, elastase-inhibitory capacity of plasma measurement, phenotypic and genotypic studies)
Other: Blood sampling
Blood tests (Alpha-1 antitrypsin protein measurement, elastase-inhibitory capacity of plasma measurement, phenotypic and genotypic studies)




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Determination of alpha-1 antitrypsin protein phenotype [ Time Frame: Samples for phenotype analysis will be performed the day of the patient enrollment ]
    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.

  2. Molecular genotyping of gene coding alpha-1 antitrypsin [ Time Frame: Samples for molecular genotyping will be performed the day of the patient enrollment ]
    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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02382367


Locations
France
Hôpital Louis Pradel - service de pneumologie
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02382367     History of Changes
Other Study ID Numbers: 2013.835
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Alpha 1-Antitrypsin
Protein C Inhibitor
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action