Alpha-1 Foundation Research Registry

NCT ID: NCT00499941

Last Updated: 2021-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6655 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-04-30

Study Completion Date

2021-01-31

Brief Summary

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The Alpha-1 Foundation Research Registry is a confidential database made up of individuals diagnosed with severe alpha-1 antitrypsin deficiency (Alpha-1) or the carrier state.

Detailed Description

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The Registry was established in 1997 by the Alpha-1 Foundation to facilitate research initiatives and promote the development of improved treatments and a cure for Alpha-1. Located at the Medical University of South Carolina (MUSC) in Charleston, the Registry employs procedures that ensure the most stringent confidentiality of participants. The Registry operates under the direction of the Alpha-1 Foundation Board of Directors and is guided by an Advisory Committee comprised of leaders in the medical, ethical, scientific and Alpha communities. Individuals enrolled in the Registry have the ongoing opportunity to participate directly in clinical trials of new therapeutic approaches in addition to other research opportunities.

Conditions

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Alpha 1-Antitrypsin Deficiency

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Individuals of all ages who are diagnosed with severe alpha-1 antitrypsin deficiency or the carrier state
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alpha-1 Foundation

OTHER

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Charlie Strange

Professor of Pulmonary and Critical Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charlie Strange, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical University of South Carolina. Division of Pulmonary and Critical Care Medicine

Charleston, South Carolina, United States

Site Status

Countries

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United States

References

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Williams PH, Shore L, Sineath M, Quill J, Warner B, Keith J, Walker D, Wienke S, Flavin S, Strange C. Genetics' influence on patient experiences with a rare chronic disorder: a photovoice study of living with alpha-1 antitrypsin deficiency. Nurs Clin North Am. 2013 Dec;48(4):627-36. doi: 10.1016/j.cnur.2013.09.008.

Reference Type BACKGROUND
PMID: 24295190 (View on PubMed)

Smith RA, Wienke S, Coffman DL. Alpha-1 couples: interpersonal and intrapersonal predictors of spousal communication and stress. J Genet Couns. 2014 Apr;23(2):212-20. doi: 10.1007/s10897-013-9639-6. Epub 2013 Aug 11.

Reference Type BACKGROUND
PMID: 23934327 (View on PubMed)

Smith RA, Wienke SE, Baker MK. Classifying married adults diagnosed with alpha-1 antitrypsin deficiency based on spousal communication patterns using latent class analysis: insights for intervention. J Genet Couns. 2014 Jun;23(3):299-310. doi: 10.1007/s10897-013-9661-8. Epub 2013 Nov 1.

Reference Type BACKGROUND
PMID: 24177906 (View on PubMed)

Holm KE, Wamboldt FS, Ford DW, Sandhaus RA, Strand M, Strange C, Hoth KF. The prospective association of perceived criticism with dyspnea in chronic lung disease. J Psychosom Res. 2013 May;74(5):450-3. doi: 10.1016/j.jpsychores.2013.02.001. Epub 2013 Feb 28.

Reference Type BACKGROUND
PMID: 23597335 (View on PubMed)

Holm KE, Borson S, Sandhaus RA, Ford DW, Strange C, Bowler RP, Make BJ, Wamboldt FS. Differences in adjustment between individuals with alpha-1 antitrypsin deficiency (AATD)-associated COPD and non-AATD COPD. COPD. 2013 Apr;10(2):226-34. doi: 10.3109/15412555.2012.719049.

Reference Type BACKGROUND
PMID: 23547634 (View on PubMed)

Hoth KF, Wamboldt FS, Strand M, Ford DW, Sandhaus RA, Strange C, Bekelman DB, Holm KE. Prospective impact of illness uncertainty on outcomes in chronic lung disease. Health Psychol. 2013 Nov;32(11):1170-4. doi: 10.1037/a0032721. Epub 2013 Jun 17.

Reference Type BACKGROUND
PMID: 23772888 (View on PubMed)

Hoth KF, Ford DW, Sandhaus RA, Strange C, Wamboldt FS, Holm KE. Alcohol use predicts ER visits in individuals with alpha-1 antitrypsin deficiency (AATD) associated COPD. COPD. 2012 Aug;9(4):417-25. doi: 10.3109/15412555.2012.684414. Epub 2012 May 31.

Reference Type BACKGROUND
PMID: 22651849 (View on PubMed)

Stoller JK, Brantly M, Fleming LE, Bean JA, Walsh J. Formation and current results of a patient-organized registry for alpha(1)-antitrypsin deficiency. Chest. 2000 Sep;118(3):843-8. doi: 10.1378/chest.118.3.843.

Reference Type RESULT
PMID: 10988213 (View on PubMed)

Bowlus CL, Willner I, Zern MA, Reuben A, Chen P, Holladay B, Xie L, Woolson RF, Strange C. Factors associated with advanced liver disease in adults with alpha1-antitrypsin deficiency. Clin Gastroenterol Hepatol. 2005 Apr;3(4):390-6. doi: 10.1016/s1542-3565(05)00082-0.

Reference Type RESULT
PMID: 15822045 (View on PubMed)

Eden E, Strange C, Holladay B, Xie L. Asthma and allergy in alpha-1 antitrypsin deficiency. Respir Med. 2006 Aug;100(8):1384-91. doi: 10.1016/j.rmed.2005.11.017. Epub 2006 Jan 5.

Reference Type RESULT
PMID: 16403617 (View on PubMed)

McGee D, Strange C, McClure R, Schwarz L, Erven M. The Alpha-1 Association Genetic Counseling Program: an innovative approach to service. J Genet Couns. 2011 Aug;20(4):330-6. doi: 10.1007/s10897-011-9355-z. Epub 2011 Mar 19.

Reference Type RESULT
PMID: 21424325 (View on PubMed)

Related Links

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http://www.alphaoneregistry.org

Alpha-1 Foundation Research Registry Website

Other Identifiers

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HR 9059

Identifier Type: -

Identifier Source: org_study_id

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