Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
OBSERVATIONAL
1999-01-31
2007-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Role of T-Cells in Asthma
NCT00001408
Endotoxin and Bronchial Inflammation in Asthma
NCT00005550
Longitudinal Study of Asthma From Birth to Adulthood
NCT00005475
Community Based Study of Adult Onset Asthma
NCT00005544
Inflammatory Processes in the Airway of Asthmatics With Persistent Bronchial Hyperreactivity
NCT00217854
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Yale University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Adam Wisnewski
Role:
Yale University
References
Explore related publications, articles, or registry entries linked to this study.
Wisnewski AV, Srivastava R, Herick C, Xu L, Lemus R, Cain H, Magoski NM, Karol MH, Bottomly K, Redlich CA. Identification of human lung and skin proteins conjugated with hexamethylene diisocyanate in vitro and in vivo. Am J Respir Crit Care Med. 2000 Dec;162(6):2330-6. doi: 10.1164/ajrccm.162.6.2002086.
Wisnewski AV, Cain H, Magoski N, Wang H, Holm CT, Redlich CA. Human gamma/delta T-cell lines derived from airway biopsies. Am J Respir Cell Mol Biol. 2001 Mar;24(3):332-8. doi: 10.1165/ajrcmb.24.3.4325.
Redlich CA, Stowe MH, Coren BA, Wisnewski AV, Holm CT, Cullen MR. Diisocyanate-exposed auto body shop workers: a one-year follow-up. Am J Ind Med. 2002 Dec;42(6):511-8. doi: 10.1002/ajim.10143.
Wisnewski AV, Liu Q, Miller JJ, Magoski N, Redlich CA. Effects of hexamethylene diisocyanate exposure on human airway epithelial cells: in vitro cellular and molecular studies. Environ Health Perspect. 2002 Sep;110(9):901-7. doi: 10.1289/ehp.02110901.
Liu Q, Wisnewski AV. Recent developments in diisocyanate asthma. Ann Allergy Asthma Immunol. 2003 May;90(5 Suppl 2):35-41. doi: 10.1016/s1081-1206(10)61647-x.
Wisnewski AV, Stowe MH, Cartier A, Liu Q, Liu J, Chen L, Redlich CA. Isocyanate vapor-induced antigenicity of human albumin. J Allergy Clin Immunol. 2004 Jun;113(6):1178-84. doi: 10.1016/j.jaci.2004.03.009.
Wisnewski AV, Herrick CA, Liu Q, Chen L, Bottomly K, Redlich CA. Human gamma/delta T-cell proliferation and IFN-gamma production induced by hexamethylene diisocyanate. J Allergy Clin Immunol. 2003 Sep;112(3):538-46. doi: 10.1016/s0091-6749(03)01865-7.
Wisnewski AV, Liu Q, Liu J, Redlich CA. Glutathione protects human airway proteins and epithelial cells from isocyanates. Clin Exp Allergy. 2005 Mar;35(3):352-7. doi: 10.1111/j.1365-2222.2005.02185.x.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
5093
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.