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Management of Patients With Alpha-1 Antitrypsin Deficiency Associated Emphysema

NCT ID: NCT00700934

Last Updated: 2010-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-02-28

Study Completion Date

2012-02-29

Brief Summary

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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

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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.

Conditions

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Alpha 1-Antitrypsin Deficiency Emphysema

Keywords

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FEV1 mortality Quality of life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Liver or lung transplantation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Assistance Publique Hopitaux de Paris

Principal Investigators

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Gabriel Thabut, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Departement d'épidémiologie, Hôpital Bichat

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Gabriel Thabut, MD

Role: CONTACT

Phone: 1 40 87 57 12

Email: [email protected]

References

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Gauvain C, Mornex JF, Pison C, Cuvelier A, Balduyck M, Pujazon MC, Fournier M, AitIlalne B, Thabut G. Health-related quality of life in patients with alpha-1 antitrypsin deficiency: the French experience. COPD. 2015 May;12 Suppl 1:46-51. doi: 10.3109/15412555.2015.1022645.

Reference Type DERIVED
PMID: 25938292 (View on PubMed)

Thabut G, Mornex JF, Pison C, Cuvelier A, Balduyck M, Pujazon MC, Fournier M, AitIlalne B, Porcher R. Performance of the BODE index in patients with alpha1-antitrypsin deficiency-related COPD. Eur Respir J. 2014 Jul;44(1):78-86. doi: 10.1183/09031936.00168113. Epub 2014 Feb 13.

Reference Type DERIVED
PMID: 24525449 (View on PubMed)

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id