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

Chronic Obstructive Pulmonary Disease Clinical Trial

— PFT  

Official title:

Targeted Detection of Alpha-1 Antitrypsin Deficiency in Patients Referred for Pulmonary Function Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419158
• Other study ID #: PFT-001
• Status: Completed
• Phase: N/A
• First received: August 16, 2011
• Last updated: January 18, 2012
• Start date: January 2008
• Est. completion date: January 2010

Study information

• Verified date: September 2011
• Source: Alpha-1 Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Office of Human Research Protection
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3457
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alpha 1-Antitrypsin Deficiency
• Alpha-1 Antitrypsin Deficiency
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Puerto Rico	San Juan City Hospital	Centro Medico Metropolitano
United States	Emory Crawford Long Hospital	Atlanta	Georgia
United States	Emory University	Atlanta	Georgia
United States	University of North Carolina at Chapel Hill	Chapel HIll	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Atlanta VA Medical Center	Decatur	Georgia
United States	National Jewish Medical and Research Center	Denver	Colorado
United States	University of Florida (Gainesville)	Gainesville	Florida
United States	University of Florida (Jacksonville)	Jacksonville	Florida
United States	University of California Los Angeles	Los Angeles	California
United States	Miami VA Medical Center	Miami	Florida
United States	University of Miami	Miami	Florida
United States	St. Luke's-Roosevelt Hospital Center	New York	New York
United States	Oregon Health & Science University	Portland	Oregon
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	University of Texas Health Science Center at Tyler	Tyler	Texas
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alpha-1 Foundation

Countries where clinical trial is conducted

United States,  Puerto Rico,