Management of Patients With Alpha-1 Antitrypsin Deficiency Associated Emphysema

This study is currently recruiting participants.

Verified by Assistance Publique - Hôpitaux de Paris, June 2008

First Received: June 18, 2008 Last Updated: July 2, 2008 History of Changes

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00700934

Purpose

The aim of this study is to describe the natural history of patients with alpha-1 antitrypsin associated emphysema and to figure out associated prognostic factors.

Condition
Alpha 1-Antitrypsin Deficiency Emphysema

Genetics Home Reference related topics: alpha-1 antitrypsin deficiency

MedlinePlus related topics: Alpha-1 Antitrypsin Deficiency Emphysema

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Management of Patients With Alpha-1 Antitrypsin Deficiency Associated Emphysema. A National Registry.

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	300
Study Start Date:	February 2005
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Detailed Description:

All patients who suffer from this disease are followed every 6 months during a 5 years period. FEV1 decline is the primary endpoint. Quality of life assessed using the Saint George's Respiratory Questionary is recorded too.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Emphysema associated alpha-1 antitrypsin deficiency

Criteria

Inclusion Criteria:

Serum alpha one antitrypsin < 0.8 g/l
Emphysema diagnosed by CT scan
Adult
Obstructive disorder

Exclusion Criteria:

Liver or lung transplantation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700934

Contacts

Contact: Gabriel Thabut, MD

1 40 87 57 12

g.thabut@bch.aphp.fr

Locations

France
Departement d'épidémiologie, Hôpital Bichat	Recruiting
Paris, France, 75018
Principal Investigator: Gabriel Thabut, MD

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Gabriel Thabut, MD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Responsible Party:	Assistance Publique Hopitaux de Paris ( Docteur Gabriel Thabut )
Study ID Numbers:	001
Study First Received:	June 18, 2008
Last Updated:	July 2, 2008
ClinicalTrials.gov Identifier:	NCT00700934 History of Changes
Health Authority:	France: Institutional Ethical Committee

Keywords provided by Assistance Publique - Hôpitaux de Paris:

FEV1
mortality
Quality of life

Study placed in the following topic categories:

Emphysema
Serine Proteinase Inhibitors
Quality of Life
Protease Inhibitors
Pulmonary Emphysema
Lung Diseases, Obstructive
Alpha 1-Antitrypsin

Protein C Inhibitor
Respiratory Tract Diseases
Alpha 1-Antitrypsin Deficiency
Lung Diseases
Connective Tissue Diseases
Alpha 1-antitrypsin Deficiency
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Emphysema
Serine Proteinase Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors
Pulmonary Emphysema
Lung Diseases, Obstructive

Alpha 1-Antitrypsin
Pathologic Processes
Respiratory Tract Diseases
Alpha 1-Antitrypsin Deficiency
Lung Diseases
Trypsin Inhibitors
Connective Tissue Diseases
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 07, 2009