NCT01419158

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,457

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Geographic Reach
2 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2011

Completed
Last Updated

January 19, 2012

Status Verified

September 1, 2011

Enrollment Period

2 years

First QC Date

August 16, 2011

Last Update Submit

January 18, 2012

Conditions

Alpha-1 Antitrypsin DeficiencyChronic Obstructive Pulmonary Disease

Keywords

Alpha-1 antitrypsinAlpha-1 antitrypsin deficiencyChronic obstructive pulmonary disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals reporting for pulmonary function testing who meet criteria for the diagnosis of chronic obstructive pulmonary disease

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

University of Florida (Gainesville)

Gainesville, Florida, 32610, United States

Location

University of Florida (Jacksonville)

Jacksonville, Florida, 32209, United States

Location

University of Miami

Miami, Florida, 33101, United States

Location

Miami VA Medical Center

Miami, Florida, 33125, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33332, United States

Location

Emory Crawford Long Hospital

Atlanta, Georgia, 30308, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

St. Luke's-Roosevelt Hospital Center

New York, New York, 10025, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Texas Health Science Center at Tyler

Tyler, Texas, 75708, United States

Location

San Juan City Hospital

Centro Medico Metropolitano, San Juan, 09036, Puerto Rico

Location

MeSH Terms

Conditions

alpha 1-Antitrypsin DeficiencyPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSubcutaneous EmphysemaEmphysemaPathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveChronic DiseaseDisease Attributes

Study Officials

  • Robert A Sandhaus, M.D., Ph.D.

    National Jewish Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2011

First Posted

August 18, 2011

Study Start

January 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

January 19, 2012

Record last verified: 2011-09

Locations

US(18)PR(1)