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% 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.
Gender	Both
Ages	18 Years - N/A
Accepts Healthy Volunteers	No
Contacts ^††	, , , ,
Location Countries ^†	Puerto Rico, United States,
Administrative Information
NCT ID ^†	NCT01419158
Organization ID	PFT-001
Secondary IDs ^††
Responsible Party	,
Study Sponsor ^†	Alpha-1 Foundation
Collaborators ^††
Investigators ^†	Principal Investigator: Robert A Sandhaus, M.D., Ph.D., National Jewish Health
Information Provided By	Alpha-1 Foundation
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.