Management of Patients With Alpha-1 Antitrypsin Deficiency Associated Emphysema

• Conditions: Alpha 1-Antitrypsin Deficiency; Emphysema

• Registration Number: NCT00700934
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

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 Timeline

• Study Start: 2005-02
• Status Verified: 2008-06
• Study First Submitted: 2008-06-18
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Last Update Submitted: 2010-12-06
• Last Update Posted: 2010-12-07
• Primary Completion: 2011-02
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Serum alpha one antitrypsin < 0.8 g/l
• Emphysema diagnosed by CT scan
• Adult
• Obstructive disorder

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Exclusion Criteria

• Liver or lung transplantation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Departement d'épidémiologie, Hôpital Bichat; 🇫🇷 Paris, France