Trial record 2 of 4 for:    "Alveolitis extrinsic allergic"

Bronchoalveolar Immune Response Determination (BIRD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Bossink, A.W.J..
Recruitment status was  Not yet recruiting
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
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Utrecht
  More Information

Publications:
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
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Interstitial
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 22, 2014