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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01237145
Other study ID # BIRD01
Secondary ID
Status Completed
Phase N/A
First received November 7, 2010
Last updated January 17, 2018
Start date September 2011
Est. completion date December 2012

Study information

Verified date January 2018
Source Bossink, A.W.J.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Subjects suffering from extrinsic allergic alveolitis caused by pigeons will undergo a broncho alveolar lavage. Cells obtained from this BAL will be used for ELISPOT technique with pigeon specific antigens


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- suspicion of pigeon induced extrinsic alveolitis

Exclusion Criteria:

- use of oral steroids

- unable to give informed consent

- age below 18

Study Design


Locations

Country Name City State
Netherlands Diakonessenhuis Utrecht Utrecht

Sponsors (1)

Lead Sponsor Collaborator
Bossink, A.W.J.

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Jafari C, Thijsen S, Sotgiu G, Goletti D, Domínguez Benítez 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. — View Citation

Kösters 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. — View Citation

Losi 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. Epub 2007 Aug 22. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Elispot response in cells from blood ELispots will be performed the same day as blood collection, results will be available the next day 2 days
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