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

Sponsor

Alpha-1 Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT01419158

Collaborator

(none)

3,457

Enrollment

Locations

Duration (Months)

181.9

Patients Per Site

7.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alpha-1 Antitrypsin Deficiency Chronic Obstructive Pulmonary Disease

Study Design

Study Type:

Observational

Actual Enrollment :

3457 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2010

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of California Los Angeles	Los Angeles	California	United States	90095
2	National Jewish Medical and Research Center	Denver	Colorado	United States	80206
3	University of Florida (Gainesville)	Gainesville	Florida	United States	32610
4	University of Florida (Jacksonville)	Jacksonville	Florida	United States	32209
5	University of Miami	Miami	Florida	United States	33101
6	Miami VA Medical Center	Miami	Florida	United States	33125
7	Cleveland Clinic Florida	Weston	Florida	United States	33332
8	Emory Crawford Long Hospital	Atlanta	Georgia	United States	30308
9	Emory University	Atlanta	Georgia	United States	30322
10	Atlanta VA Medical Center	Decatur	Georgia	United States	30033
11	University of Chicago	Chicago	Illinois	United States	60637
12	Mayo Clinic Rochester	Rochester	Minnesota	United States	55905
13	St. Luke's-Roosevelt Hospital Center	New York	New York	United States	10025
14	University of North Carolina at Chapel Hill	Chapel HIll	North Carolina	United States	27599
15	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
16	Oregon Health & Science University	Portland	Oregon	United States	97239
17	Medical University of South Carolina	Charleston	South Carolina	United States	29425
18	University of Texas Health Science Center at Tyler	Tyler	Texas	United States	75708
19	San Juan City Hospital	Centro Medico Metropolitano		Puerto Rico	09036