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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01419158
Other study ID # PFT-001
Secondary ID
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


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, 

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