Management of Patients With Alpha-1 Antitrypsin Deficiency Associated Emphysema - Full Text View

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

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

Responsible Party:	Assistance Publique Hopitaux de Paris ( Docteur Gabriel Thabut )
Study ID Numbers:	001
First Received:	June 18, 2008
Last Updated:	July 2, 2008
ClinicalTrials.gov Identifier:	NCT00700934
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:

Pulmonary Emphysema

Emphysema

Protein C Inhibitor

Alpha 1-Antitrypsin

Lung Diseases, Obstructive

Respiratory Tract Diseases

Alpha 1-Antitrypsin Deficiency

Lung Diseases

Alpha 1-antitrypsin deficiency

Connective Tissue Diseases

Quality of Life

Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Serine Proteinase Inhibitors

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Trypsin Inhibitors

Enzyme Inhibitors

Pharmacologic Actions

Protease Inhibitors

ClinicalTrials.gov processed this record on October 24, 2008