AsthmaNCT00005549
Isocyanate Antigens and T Cells That Cause Asthma
An observational study of Asthma and Lung Diseases, run by Yale University.
Trial summary
To investigate whether isocyanate-induced asthma is dependent on isocyanate antigen-driven T-cell mediated, airway inflammation. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Asthma, Lung Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 1999to Apr 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To investigate whether isocyanate-induced asthma is dependent on isocyanate antigen-driven T-cell mediated, airway inflammation.
Read the detailed description
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.
- Conditions
- Asthma, Lung Diseases
- Medical subject headings
- Asthma, Lung Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJan 1999
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Adam Wisnewski, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005549
- Sponsor's protocol ID
- 5093
- Other IDs
- R01HL062622
- Status last verified
- Mar 2014
- First submitted
- 25 May 2000
- Last updated
- 14 Mar 2014
- Results posted
- No
Publications
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.
PubMed 11112159Wisnewski 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.
PubMed 11245633Redlich 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.
PubMed 12439874Wisnewski 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.
PubMed 12204825Liu 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.
PubMed 12772950Wisnewski 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.
PubMed 15208602Wisnewski 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.
PubMed 13679813Wisnewski 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.
PubMed 15784115
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isocyanate Antigens and T Cells That Cause Asthma
- ClinicalTrials.gov ID
- NCT00005549
- Acronym / sponsor ID
- 5093
- Conditions
- Asthma, Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 1999
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate whether isocyanate-induced asthma is dependent on isocyanate antigen-driven T-cell mediated, airway inflammation.
Detailed description
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.
Study design
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2014.
- Background: PubMed 11112159Wisnewski 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.
- Background: PubMed 11245633Wisnewski 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.
- Background: PubMed 12439874Redlich 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.
- Background: PubMed 12204825Wisnewski 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.
- Background: PubMed 12772950Liu 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.
- Background: PubMed 15208602Wisnewski 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.
- Background: PubMed 13679813Wisnewski 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.
- Background: PubMed 15784115Wisnewski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Wisnewski
Yale University
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Lung Diseases, run by Yale University.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005549, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2014.