AsthmaNCT00005552
Isocyanate Dermal Exposures in Autobody Shops
An observational study of Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To characterize the skin route of exposure to the allergen hexamethylene diisocyanate (HDI) in the auto body industry. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Asthma, Lung Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 1999to Dec 2001
- 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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To characterize the skin route of exposure to the allergen hexamethylene diisocyanate (HDI) in the auto body industry.
Read the detailed description
BACKGROUND:
Isocyanates account for the highest number of reported cases of occupational asthma in the United States and developed countries. Prevention, however is limited by inadequate knowledge of isocyanate routes of exposure, exposure patterns, mechanisms of sensitization and other causal factors. The Survey of Painters and Repairers of Auto Bodies by Yale (SPRAY), a five-year cross-sectional epidemiologic survey of painters and repairers of autobodies at Yale was therefore initiated to address these questions. At the outset of Spray, it was not known how frequent skin contact among the painters might be. Moreover, there is new and exciting data from animal studies demonstrating that dermal rather than respiratory contact may be crucial to immune sensitization leading to asthma. Little is known, so far, about dermal exposure in autobody shops and its modifiers, especially the effectiveness of personal protective equipment (PPE) in preventing workers from skin contamination by isocyanates.
DESIGN NARRATIVE:
The study was ancillary to the SPRAY study and was integrated into it. The overall design was a cross-sectional investigation of 20 shops with 120 workers. This would allow a better understanding of the complex basis for asthma risk in these workers, and better recommendations to autobody shops and workers on protective measures for isocyanate dermal exposures.
Specific aims included: 1) Qualitatively and quantitatively assessing surface and skin contamination of HDI; 2) Identifying modifiers that affected surface and skin contamination, and specifically evaluating the effectiveness of personal protective equipment in protecting the skin from isocyanate contamination; 3) Exploring the relationships of dermal exposure with airborne exposure, biomarkers of systemic absorption and skin sensitization, and asthma-developing risk.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- 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
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- Sponsor type
- US National Institutes of Health
- Investigators
- Mark Cullen, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005552
- Sponsor's protocol ID
- 5096
- Other IDs
- R01HL062932
- Status last verified
- Aug 2004
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Liu Y, Sparer J, Woskie SR, Cullen MR, Chung JS, Holm CT, Redlich CA. Qualitative assessment of isocyanate skin exposure in auto body shops: a pilot study. Am J Ind Med. 2000 Mar;37(3):265-74. doi: 10.1002/(sici)1097-0274(200003)37:33.0.co;2-o.
PubMed 10642416
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isocyanate Dermal Exposures in Autobody Shops
- ClinicalTrials.gov ID
- NCT00005552
- Acronym / sponsor ID
- 5096
- Conditions
- Asthma, Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jan 1999
- Study completion
- Dec 2001 (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 characterize the skin route of exposure to the allergen hexamethylene diisocyanate (HDI) in the auto body industry.
Detailed description
BACKGROUND:
Isocyanates account for the highest number of reported cases of occupational asthma in the United States and developed countries. Prevention, however is limited by inadequate knowledge of isocyanate routes of exposure, exposure patterns, mechanisms of sensitization and other causal factors. The Survey of Painters and Repairers of Auto Bodies by Yale (SPRAY), a five-year cross-sectional epidemiologic survey of painters and repairers of autobodies at Yale was therefore initiated to address these questions. At the outset of Spray, it was not known how frequent skin contact among the painters might be. Moreover, there is new and exciting data from animal studies demonstrating that dermal rather than respiratory contact may be crucial to immune sensitization leading to asthma. Little is known, so far, about dermal exposure in autobody shops and its modifiers, especially the effectiveness of personal protective equipment (PPE) in preventing workers from skin contamination by isocyanates.
DESIGN NARRATIVE:
The study was ancillary to the SPRAY study and was integrated into it. The overall design was a cross-sectional investigation of 20 shops with 120 workers. This would allow a better understanding of the complex basis for asthma risk in these workers, and better recommendations to autobody shops and workers on protective measures for isocyanate dermal exposures.
Specific aims included: 1) Qualitatively and quantitatively assessing surface and skin contamination of HDI; 2) Identifying modifiers that affected surface and skin contamination, and specifically evaluating the effectiveness of personal protective equipment in protecting the skin from isocyanate contamination; 3) Exploring the relationships of dermal exposure with airborne exposure, biomarkers of systemic absorption and skin sensitization, and asthma-developing risk.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- 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 13 May 2016.
- Background: PubMed 10642416Liu Y, Sparer J, Woskie SR, Cullen MR, Chung JS, Holm CT, Redlich CA. Qualitative assessment of isocyanate skin exposure in auto body shops: a pilot study. Am J Ind Med. 2000 Mar;37(3):265-74. doi: 10.1002/(sici)1097-0274(200003)37:33.0.co;2-o.
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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.
Mark Cullen
Yale University
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. 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 NCT00005552, which also lists 1 linked publication.
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 13 May 2016.