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

Descriptive Information
Brief Title † Prevalence of Alpha-1 Antitrypsin Deficiency in Chronic Obstructive Pulmonary Disease (COPD)
Official Title † Targeted Detection of Alpha-1 Antitrypsin Deficiency in Patients Referred for Pulmonary Function Testing
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.
Detailed Description
Study Phase N/A
Study Type † Observational
Study Design † Observational Model: Case-Only, Time Perspective: Prospective
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † Alpha-1 Antitrypsin Deficiency Chronic Obstructive Pulmonary Disease
Intervention †
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status †
Estimated Enrollment † 3457
Start Date † January 2008
Completion Date January 2010
Primary Completion Date January 2010
Eligibility 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% 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.
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT01419158
Organization ID PFT-001
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Alpha-1 Foundation
Collaborators ††
Investigators † Principal Investigator: Robert A Sandhaus, M.D., Ph.D., National Jewish Health
Information Provided By
Verification Date September 2011
First Received Date † August 16, 2011
Last Updated Date January 18, 2012
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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