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Management of Patients With Alpha-1 Antitrypsin Deficiency Associated Emphysema

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00700934
First Posted: June 19, 2008
Last Update Posted: December 7, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assistance Publique - Hôpitaux de Paris
  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

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

Resource links provided by NLM:


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

Estimated Enrollment: 300
Study Start Date: February 2005
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2011 (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

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 Submitted: June 18, 2008
First Posted: June 19, 2008
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:
Emphysema
Pulmonary Emphysema
Alpha 1-Antitrypsin Deficiency
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Liver Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Subcutaneous Emphysema
Alpha 1-Antitrypsin
Protein C Inhibitor
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action