Management of Patients With Alpha-1 Antitrypsin Deficiency Associated Emphysema

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00700934
First received: June 18, 2008
Last updated: December 6, 2010
Last verified: June 2008
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Assistance Publique - Hôpitaux de Paris

Additional 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
Study First Received: June 18, 2008
Last Updated: December 6, 2010
Health Authority: France: Institutional Ethical Committee

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

Additional relevant MeSH terms:
Alpha 1-Antitrypsin Deficiency
Alpha 1-Antitrypsin
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
Protein C Inhibitor
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014