NCT01237145

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

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2010

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

November 7, 2010

Last Update Submit

January 17, 2018

Conditions

Keywords

pigeonbird fancierextrinsic allergic alveolitisBALbroncho-alveolar lavageelispotantigen

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

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

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

Study Sites (1)

Diakonessenhuis Utrecht

Utrecht, 3582 KE, Netherlands

Location

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: 19590020BACKGROUND
  • 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.

    PMID: 17715165BACKGROUND
  • 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.

    PMID: 18193383BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cells obtained from Broncho alveolar lavage and blood collection

MeSH Terms

Conditions

Alveolitis, Extrinsic Allergic

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Aik Bossink, MD PhD

    Diakonessenhuis, Utrecht

    PRINCIPAL INVESTIGATOR

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

Locations