CClinicalTrials.gg
CompletedNCT01419158PFTUpdated Jan 19, 2012

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

An observational study in Alpha-1 Antitrypsin Deficiency and Chronic Obstructive Pulmonary Disease, sponsored by Alpha-1 Foundation. Completed at 19 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-19.

Sponsored by Alpha-1 Foundation · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
3,457
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Alpha-1 Antitrypsin Deficiency
  • Chronic Obstructive Pulmonary Disease

Keywords

  • Alpha-1 antitrypsin
  • Alpha-1 antitrypsin deficiency
  • Chronic obstructive pulmonary disease
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Individuals reporting for pulmonary function testing who meet criteria for the diagnosis of chronic obstructive pulmonary disease

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

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.
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
3,457 participants (actual)
05

Study locations

19 sites
  • University of California Los Angeles
    Los Angeles, California 90095, United States
  • National Jewish Medical and Research Center
    Denver, Colorado 80206, United States
  • University of Florida (Gainesville)
    Gainesville, Florida 32610, United States
  • University of Florida (Jacksonville)
    Jacksonville, Florida 32209, United States
  • University of Miami
    Miami, Florida 33101, United States
  • Miami VA Medical Center
    Miami, Florida 33125, United States
  • Cleveland Clinic Florida
    Weston, Florida 33332, United States
  • Emory Crawford Long Hospital
    Atlanta, Georgia 30308, United States
  • Emory University
    Atlanta, Georgia 30322, United States
  • Atlanta VA Medical Center
    Decatur, Georgia 30033, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Mayo Clinic Rochester
    Rochester, Minnesota 55905, United States
  • St. Luke's-Roosevelt Hospital Center
    New York, New York 10025, United States
  • University of North Carolina at Chapel Hill
    Chapel HIll, North Carolina 27599, United States
  • The Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • University of Texas Health Science Center at Tyler
    Tyler, Texas 75708, United States
  • San Juan City Hospital
    Centro Medico Metropolitano, 09036, Puerto Rico
06

Registry details

Key details

Study ID
NCT01419158
Lead sponsor
Alpha-1 Foundation
Responsible party
Sponsor
First posted
Aug 18, 2011
Start date
Jan 2008
Primary completion
Jan 2010
Completion
Jan 2010
Last update
Jan 19, 2012

Study contacts

Robert A Sandhaus, M.D., Ph.D.
principal investigator · National Jewish Health

Oversight

Data monitoring committee
No
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