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Completed

NCT Number: NCT02382367

Prevalence of Alpha-1 Antitrypsin Dysfunction in Pulmonary Emphysema

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.

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Key information

Conditions

Pulmonary Emphysema Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Louis Pradel - service de pneumologie

Bron, 69677, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: DysA

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 6, 2015
Registry last updated
Dec 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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