Prevalence of Alpha-1 Antitrypsin Deficiency in Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT01419158

Last Updated: 2012-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3457 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-01-31

Brief Summary

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Alpha-1 antitrypsin deficiency (AATD) is considered a rare genetic cause of chronic obstructive pulmonary disease (COPD) and liver disease. Recent data has suggested that AATD is not as rare as originally thought and undetected AATD may account for COPD in some patients. This study was designed to evaluate the frequency of undetected AATD in a population reporting to academic pulmonary function testing facilities who meet criteria for the diagnosis of COPD. All individuals meeting GOLD criteria for COPD will be consented and offered free testing for AATD. The results will help identify the percent of those with COPD who have undetected AATD.

Detailed Description

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Conditions

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Alpha-1 Antitrypsin Deficiency Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Male and female adults at least 18 years of age able to understand and consent to the procedures of this protocol.
* All races and ethnicities will be considered for this study.
* Post-bronchodilator values for pulmonary function tests on the day of enrollment with an FEV1 \< 80% of predicted and FEV1/FVC \< 70% (at least GOLD stage II).
* Subjects who have been tested for Alpha-1 in the past but do not know their genotype or phenotype may be included in this study.

Exclusion Criteria

* Subjects in whom post-bronchodilator spirometry is not performed.
* Subjects whose ordering physician has specifically requested that his patients not be considered for enrollment.
* Patients who have been tested for Alpha-1 in the past and know their genotype or phenotype.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alpha-1 Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert A Sandhaus, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Locations

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University of California Los Angeles

Los Angeles, California, United States

Site Status

National Jewish Medical and Research Center

Denver, Colorado, United States

Site Status

University of Florida (Gainesville)

Gainesville, Florida, United States

Site Status

University of Florida (Jacksonville)

Jacksonville, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Miami VA Medical Center

Miami, Florida, United States

Site Status

Cleveland Clinic Florida

Weston, Florida, United States

Site Status

Emory Crawford Long Hospital

Atlanta, Georgia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Atlanta VA Medical Center

Decatur, Georgia, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

St. Luke's-Roosevelt Hospital Center

New York, New York, United States

Site Status

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

University of Texas Health Science Center at Tyler

Tyler, Texas, United States

Site Status

San Juan City Hospital

Centro Medico Metropolitano, San Juan, Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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PFT-001

Identifier Type: -

Identifier Source: org_study_id

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