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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00005549 |
To investigate whether isocyanate-induced asthma is dependent on isocyanate antigen-driven T-cell mediated, airway inflammation.
Study Type: | Observational |
Study Start Date: | January 1999 |
Study Completion Date: | April 2007 |
Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
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.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
No eligibility criteria
Study ID Numbers: | 5093 |
Study First Received: | May 25, 2000 |
Last Updated: | January 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00005549 History of Changes |
Health Authority: | United States: Federal Government |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Hypersensitivity Lung Diseases, Obstructive Immune System Diseases Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |