Clinical trial NCT01237145: Bronchoalveolar Immune Response Determination
Official title: Study to Determine the Immune Response From Broncho-alveolar Cells Against Pigeon Specific Antigens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extrinsic Allergic Alveolitis
Keywords: pigeon
bird fancier
extrinsic allergic alveolitis
BAL
broncho-alveolar lavage
elispot
antigen
Lead sponsor: Bossink, A.W.J.
Sponsor class: INDIV
First posted: 2010-11-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Detailed 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

Eligibility criteria: Inclusion Criteria:

* suspicion of pigeon induced extrinsic alveolitis

Exclusion Criteria:

* use of oral steroids
* unable to give informed consent
* age below 18

Primary outcomes:
measure: ELISPOT response in cells obtained from broncho-alveolar lavage
timeFrame: 2 days
Secondary outcomes:
measure: Elispot response in cells from blood
timeFrame: 2 days
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Diakonessenhuis Utrecht
Study officials:
affiliation: Diakonessenhuis, Utrecht
name: Aik Bossink, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1183/09031936.00067307. Epub 2007 Aug 22.
citation: Kosters 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.