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

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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.
    



Study Type

Observational




Condition

Alpha-1 Antitrypsin Deficiency



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



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

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Robert A Sandhaus, M.D., Ph.D., , 

Location Countries

Puerto Rico

Location Countries

Puerto Rico

Administrative Informations


NCT ID

NCT01419158

Organization ID

PFT-001


Responsible Party

Sponsor

Study Sponsor

Alpha-1 Foundation


Study Sponsor

Robert A Sandhaus, M.D., Ph.D., Principal Investigator, National Jewish Health


Verification Date

September 2011