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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alpha-1 Foundation
ClinicalTrials.gov Identifier:
NCT01419158
First received: August 16, 2011
Last updated: January 18, 2012
Last verified: September 2011
  Purpose

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.


Condition
Alpha-1 Antitrypsin Deficiency
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Targeted Detection of Alpha-1 Antitrypsin Deficiency in Patients Referred for Pulmonary Function Testing

Resource links provided by NLM:


Further study details as provided by Alpha-1 Foundation:

Enrollment: 3457
Study Start Date: January 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.

Note: For the inclusion criteria the investigators will use the patient's GOLD status, based on percent predicted (FEV1 < 80% of predicted); however, after sending the absolute value of FEV1 to the Data Coordinating Center (DCC) the DCC will calculate the percent predicted using a standardized formula (NHANES III). For sites that do not use this predicted formula, the results obtained at the DCC may differ from those used for subject enrollment. (For example, a subject found to have an FEV1 of <80% at the study site could have an FEV1 > 80% when the DCC recalculates it). Enrollment will be based on the percent predicted at each study site. If necessary, the data from this small number of outliers will be analyzed separately.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419158

Locations
United States, California
University of California Los Angeles
Los Angeles, California, United States, 90095
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
United States, Florida
University of Florida (Gainesville)
Gainesville, Florida, United States, 32610
University of Florida (Jacksonville)
Jacksonville, Florida, United States, 32209
Miami VA Medical Center
Miami, Florida, United States, 33125
University of Miami
Miami, Florida, United States, 33101
Cleveland Clinic Florida
Weston, Florida, United States, 33332
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Emory Crawford Long Hospital
Atlanta, Georgia, United States, 30308
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, New York
St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10025
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel HIll, North Carolina, United States, 27599
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
University of Texas Health Science Center at Tyler
Tyler, Texas, United States, 75708
Puerto Rico
San Juan City Hospital
Centro Medico Metropolitano, Puerto Rico, 09036
Sponsors and Collaborators
Alpha-1 Foundation
Investigators
Principal Investigator: Robert A Sandhaus, M.D., Ph.D. National Jewish Health
  More Information

No publications provided

Responsible Party: Alpha-1 Foundation
ClinicalTrials.gov Identifier: NCT01419158     History of Changes
Other Study ID Numbers: PFT-001
Study First Received: August 16, 2011
Last Updated: January 18, 2012
Health Authority: United States: Office of Human Research Protection

Keywords provided by Alpha-1 Foundation:
Alpha-1 antitrypsin
Alpha-1 antitrypsin deficiency
Chronic obstructive pulmonary disease

Additional relevant MeSH terms:
Alpha 1-Antitrypsin Deficiency
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Liver Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Subcutaneous Emphysema
Emphysema
Pathologic Processes
Alpha 1-Antitrypsin
Protein C Inhibitor
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014