Trial record 2 of 2 for: "Alveolitis extrinsic allergic"

Previous Study | Return to List | Next Study

Bronchoalveolar Immune Response Determination (BIRD)

This study is not yet open for participant recruitment.

Verified June 2011 by Bossink, A.W.J.

Sponsor:

Information provided by:

Bossink, A.W.J.

ClinicalTrials.gov Identifier:

NCT01237145

First received: November 7, 2010

Last updated: June 14, 2011

Last verified: June 2011

History of Changes

Purpose

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.

Condition
Extrinsic Allergic Alveolitis

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Study to Determine the Immune Response From Broncho-alveolar Cells Against Pigeon Specific Antigens

Further study details as provided by Bossink, A.W.J.:

Primary Outcome Measures:

ELISPOT response in cells obtained from broncho-alveolar lavage [ Time Frame: 2 days ] [ Designated as safety issue: No ]
All elispots will be performed the same day, the end point will be available the next day

Secondary Outcome Measures:

Elispot response in cells from blood [ Time Frame: 2 days ] [ Designated as safety issue: No ]
ELispots will be performed the same day as blood collection, results will be available the next day

Biospecimen Retention: Samples Without DNA

Cells obtained from Broncho alveolar lavage and blood collection

Estimated Enrollment:	25
Study Start Date:	September 2011
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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

Criteria

Inclusion Criteria:

suspicion of pigeon induced extrinsic alveolitis

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237145

Contacts

Contact: Aik Bossink, MD PhD	+31 6 16092662	aikbossink@me.com
Contact: Melanie Dubbers, MD		m.a.dubbers@isala.nl

Locations

Netherlands
Diakonessenhuis Utrecht	Not yet recruiting
Utrecht, Netherlands, 3582 KE
Contact: Aik Bossink, MD PhD +31 6 16092662 aikbossink@me.com
Principal Investigator: Aik Bossink, MD PhD
Sub-Investigator: Melanie Dubbers, MD

Sponsors and Collaborators

Bossink, A.W.J.

Investigators

Principal Investigator:

Aik Bossink, MD PhD

Diakonessenhuis

More Information

Publications:

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. Epub 2009 Jul 9.

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.

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. Epub 2008 Jan 12.

Responsible Party:	Bossink A.W.J., Diakonessenhuis
ClinicalTrials.gov Identifier:	NCT01237145 History of Changes
Other Study ID Numbers:	BIRD01
Study First Received:	November 7, 2010
Last Updated:	June 14, 2011
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Bossink, A.W.J.:

pigeon
bird fancier
extrinsic allergic alveolitis
BAL

broncho-alveolar lavage
elispot
antigen

Additional relevant MeSH terms:

Alveolitis, Extrinsic Allergic
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013

To Top