NCT00700934

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

December 7, 2010

Status Verified

June 1, 2008

Enrollment Period

6 years

First QC Date

June 18, 2008

Last Update Submit

December 6, 2010

Conditions

Alpha 1-Antitrypsin DeficiencyEmphysema

Keywords

FEV1mortalityQuality of life

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Emphysema associated alpha-1 antitrypsin deficiency

You may qualify if:

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

You may not qualify if:

  • Liver or lung transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement d'épidémiologie, Hôpital Bichat

Paris, 75018, France

RECRUITING

Related Publications (2)

  • 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.

    PMID: 25938292DERIVED

  • 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.

    PMID: 24525449DERIVED

MeSH Terms

Conditions

alpha 1-Antitrypsin DeficiencyEmphysema

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSubcutaneous EmphysemaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gabriel Thabut, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Thabut, MD

CONTACT

1 40 87 57 12g.thabut@bch.aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 18, 2008

First Posted

June 19, 2008

Study Start

February 1, 2005

Primary Completion

February 1, 2011

Study Completion

February 1, 2012

Last Updated

December 7, 2010

Record last verified: 2008-06

Locations

FR(1)