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Management of Patients With Alpha-1 Antitrypsin Deficiency Associated Emphysema

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ClinicalTrials.gov Identifier: NCT00700934
Recruitment Status : Unknown
Verified June 2008 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : June 19, 2008
Last Update Posted : December 7, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease
Alpha 1-Antitrypsin Deficiency Emphysema

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.

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Management of Patients With Alpha-1 Antitrypsin Deficiency Associated Emphysema. A National Registry.
Study Start Date : February 2005
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : February 2012


Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Docteur Gabriel Thabut, Assistance Publique Hopitaux de Paris
ClinicalTrials.gov Identifier: NCT00700934     History of Changes
Other Study ID Numbers: 001
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: December 7, 2010
Last Verified: June 2008

Keywords provided by Assistance Publique - Hôpitaux de Paris:
FEV1
mortality
Quality of life

Additional relevant MeSH terms:
Alpha 1-Antitrypsin Deficiency
Alpha 1-Antitrypsin
Protein C Inhibitor
Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Liver Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Subcutaneous Emphysema
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action