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
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: 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:
Emphysema
Pulmonary Emphysema
Alpha 1-Antitrypsin Deficiency
Pathologic Processes
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014