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Isocyanate Antigens and T Cells That Cause Asthma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00005549
First received: May 25, 2000
Last updated: March 13, 2014
Last verified: March 2014

May 25, 2000
March 13, 2014
January 1999
April 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00005549 on ClinicalTrials.gov Archive Site
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Isocyanate Antigens and T Cells That Cause Asthma
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To investigate whether isocyanate-induced asthma is dependent on isocyanate antigen-driven T-cell mediated, airway inflammation.

BACKGROUND:

Isocyanates are a group of highly reactive widely used low-molecular weight chemicals, and are the most commonly reported cause of occupation asthma in developed countries. Yet, the mechanisms by which isocyanates cause asthma are not well defined.

DESIGN NARRATIVE:

The study investigates isocyanate antigen-driven T-cell responses in vitro-, following in vivo exposure using patient samples acquired through collaboration with ongoing field epidemiological and clinical studies. The study compares isocyanate antigen-reactive T-cells from primary exposure sites (skin/lung) with those from blood, to evaluate potential routes of sensitization and identify diagnostic indicators of isocyanate sensitivity/susceptibility. Specifically, the study : generates and characterizes hexamethylene diisocyanate (HDI) antigens including isocyanate metabolites, and isocyanate conjugated t normal human and foreign proteins; evaluates the T-cell antigenicity of the HDI antigens, based on blood and lung lymphocyte proliferation, cytokine production, and phenotype in order to identify the molecular form of HDI that initiates airway cytokine production in asthma patients; establishes T-cell lines from the skin, lung and peripheral blood of HDI asthma patients and characterizes the phenotype, antigen specificity, cytokine production and TCR expression of isocyanate responsive T-cells in these different compartments; compares isocyanate responsive of T-cells found in the skin, lung and blood and correlates with clinical sensitivity to determine characteristics associated with exposure and sensitization leading to clinical asthma.

The study was renewed in FY 2002 to extend follow-up and analysis through March 2007.

Observational
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  • Asthma
  • Lung Diseases
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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April 2007
April 2007   (final data collection date for primary outcome measure)

No eligibility criteria

Male
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00005549
5093, R01HL062622
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Yale University
Yale University
National Heart, Lung, and Blood Institute (NHLBI)
Investigator: Adam Wisnewski Yale University
Yale University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP