Management of Patients With Alpha-1 Antitrypsin Deficiency Associated Emphysema

Emphysema Clinical Trial

Official title:

Management of Patients With Alpha-1 Antitrypsin Deficiency Associated Emphysema. A National Registry.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00700934
• Other study ID #: 001
• Status: Recruiting
• Phase: N/A
• First received: June 18, 2008
• Last updated: December 6, 2010
• Start date: February 2005
• Est. completion date: February 2012

Study information

• Verified date: June 2008
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Gabriel Thabut, MD
• Phone: 1 40 87 57 12
• Email: g.thabut[@]bch.aphp.fr
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Serum alpha one antitrypsin < 0.8 g/l

• Emphysema diagnosed by CT scan

• Adult

• Obstructive disorder

Exclusion Criteria:

• Liver or lung transplantation

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alpha 1-Antitrypsin Deficiency
• Emphysema
• Pulmonary Emphysema

Locations

Country	Name	City	State
France	Departement d'épidémiologie, Hôpital Bichat	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France,