Bronchoalveolar Immune Response Determination
BIRD
Study to Determine the Immune Response From Broncho-alveolar Cells Against Pigeon Specific Antigens
1 other identifier
observational
10
1 country
1
Brief Summary
The purpose of this study is to establish if cells present in lung tissue during extrinsic allergic alveolitis (EAA) are able to elicit an immune response against specific antigens. The hypothesis is: cells in BAL lavage fluid from patients with EAA will be responsive to specific antigens and this response can be measured using ELISPOT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2010
CompletedFirst Posted
Study publicly available on registry
November 9, 2010
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJanuary 19, 2018
January 1, 2018
1 year
November 7, 2010
January 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ELISPOT response in cells obtained from broncho-alveolar lavage
All elispots will be performed the same day, the end point will be available the next day
2 days
Secondary Outcomes (1)
Elispot response in cells from blood
2 days
Study Arms (2)
non-EAA, pigeon
subject with BAL because of diseases not suspected to be EAA
EAA, pigeon
Bird fanciers with a typical clinical presentation suspected for pigeon induced EAA
Eligibility Criteria
Patients suspected to have pigeon induced extrinsic allergic alveolitis will be recruited by advertisment in bird fanciers journals. Controls will be patients at the department of pulmonology and tuberculosis needing examination for other reasons
You may qualify if:
- suspicion of pigeon induced extrinsic alveolitis
You may not qualify if:
- use of oral steroids
- unable to give informed consent
- age below 18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bossink, A.W.J.lead
Study Sites (1)
Diakonessenhuis Utrecht
Utrecht, 3582 KE, Netherlands
Related Publications (3)
Jafari C, Thijsen S, Sotgiu G, Goletti D, Dominguez Benitez JA, Losi M, Eberhardt R, Kirsten D, Kalsdorf B, Bossink A, Latorre I, Migliori GB, Strassburg A, Winteroll S, Greinert U, Richeldi L, Ernst M, Lange C; Tuberculosis Network European Trialsgroup. Bronchoalveolar lavage enzyme-linked immunospot for a rapid diagnosis of tuberculosis: a Tuberculosis Network European Trialsgroup study. Am J Respir Crit Care Med. 2009 Oct 1;180(7):666-73. doi: 10.1164/rccm.200904-0557OC. Epub 2009 Jul 9.
PMID: 19590020BACKGROUNDLosi M, Bossink A, Codecasa L, Jafari C, Ernst M, Thijsen S, Cirillo D, Ferrarese M, Greinert U, Fabbri LM, Richeldi L, Lange C; European Tuberculosis Network TBNET. Use of a T-cell interferon-gamma release assay for the diagnosis of tuberculous pleurisy. Eur Respir J. 2007 Dec;30(6):1173-9. doi: 10.1183/09031936.00067307. Epub 2007 Aug 22.
PMID: 17715165BACKGROUNDKosters K, Nau R, Bossink A, Greiffendorf I, Jentsch M, Ernst M, Thijsen S, Hinks T, Lalvani A, Lange C. Rapid diagnosis of CNS tuberculosis by a T-cell interferon-gamma release assay on cerebrospinal fluid mononuclear cells. Infection. 2008 Dec;36(6):597-600. doi: 10.1007/s15010-007-7316-0. Epub 2008 Jan 12.
PMID: 18193383BACKGROUND
Biospecimen
Cells obtained from Broncho alveolar lavage and blood collection
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aik Bossink, MD PhD
Diakonessenhuis, Utrecht
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDIV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
November 7, 2010
First Posted
November 9, 2010
Study Start
September 1, 2011
Primary Completion
September 1, 2012
Study Completion
December 1, 2012
Last Updated
January 19, 2018
Record last verified: 2018-01