Prevalence of Alpha-1 Antitrypsin Dysfunction in Pulmonary Emphysema

NCT02382367 | Completed

• 1 other identifier: 2013.835
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Emphysema

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Determination of alpha-1 antitrypsin protein phenotype

  Samples for phenotype analysis will be performed the day of the patient enrollment

• Molecular genotyping of gene coding alpha-1 antitrypsin

  Samples for molecular genotyping will be performed the day of the patient enrollment

Study Arms (1)

Pulmonary emphysema

EXPERIMENTAL

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

Other: Blood sampling

Interventions

Blood sampling OTHER

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

Pulmonary emphysema

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pulmonary emphysema highlighted by computed tomography
• Ratio Forced Expiratory Volume in 1 second (FEV1) / Vital Capacity (VC) \< 70% measured by lung function test

You may not qualify if:

• Hepatic transplant
• Patient under legal protection
• Patient not benefiting from the French Health Insurance

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Louis Pradel - service de pneumologie

Bron, 69677, France

Location

MeSH Terms

Conditions

Pulmonary Emphysema

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: March 6, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 7, 2015

Record last verified: 2015-12

Locations

FR (1)