Airway Inflammation Among Workers in the Silicon Carbide Processing Industry
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Purpose
Exposure to noxious gases and particles is associated with an increased prevalence of respiratory and cardiovascular diseases. Thus, investigation of possible airway inflammation and/or systemic inflammation in workers exposed to high levels of dust is important. Silicon Carbide (SiC) Processing Inc. provides cutting fluid (slurry) for the production of solar cells and is at present the largest provider of slurry to the solar industry worldwide. In the production process, the recyclable materials (SiC), polyethylene glycol (PEG)) of the used slurry are recovered. The airborne exposure consists mainly of SiC (dust particles) and evaporation from the recycling of PEG. High levels of dust have been measured and, seventeen per cent of the measurements in the processing hall were equal to or higher than the Norwegian occupational exposure limit. Thus, assessment of possible systemic and airway effects of this exposure is of interest. A prospective design will be applied and the effects studied by means of registration of respiratory symptoms, spirometry, nitric oxide (NO) in exhaled air, induced sputum and blood sampling over a 3 year period. Exposed subjects will also be compare with non- or low exposed subjects (administrative/office workers). Efforts will be made to include all eligible subjects and to avoid drop-outs. If early signs of airway or systemic inflammation in workers or in cells are demonstrated in the study, it will be necessary to implement measures to reduce the exposure levels.
The primary aim of the present study of workers exposed to Silicon Carbide dust in the workplace is to determine whether this exposure is associated with inflammatory changes in the lungs.
The secondary aims are: - to examine possible changes in systemic inflammatory markers and - to examine changes in lung function among Silicon Carbide processing workers during a period of 3 years. Possible changes in lung function will be monitored by spirometry and gas diffusion measurements (study A). Airway inflammatory responses and changes in circulating inflammatory markers will be assessed by examination of the induced sputum samples and blood samples every 6th month in a subgroup of workers (study B).
| Condition |
|---|
|
Obstructive Lung Disease Inflammation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Exposure to Aerosols and Airway Inflammation Among Workers in the Silicon Carbide Processing Industry |
Induced sputum, serum, citrate- plasma, EDTA-plasma, whole blood and a PaxGene sample for DNA isolation. Cell isolation, RNA isolation and gene expression analysis. Fluid phase analyses.
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Main study group
Inclusion criteria: Employment at one of the plants (SiC I) and (SiC II) in Porsgrunn. Both administrative/office workers and workers in the production and maintenance departments will be invited to participate. Non-smokers and smokers and male and female workers will be included in the main study group (study A). Sputum part of study: nonsmokers. |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Employment at one of the plants (SiC I) and (SiC II) in Porsgrunn. Both administrative/office workers in the production and maintenance departments will be invited to participate. Non- smokers and smokers and male and female workers will be included in the main study group. Only non- smokers will be included in the sputum part of the study.
Inclusion Criteria:
- Employment at SiC plant in Porsgrunn;
Exclusion Criteria for sputum study:
- smoking
- active airway infection or less then 3 weeks after recovery
- active allergy
Contacts and Locations| Contact: Svitlana Shkabura, Physician | +47 35003109 | svitlana.shkabura@sthf.no |
| Contact: Anne K Møller Fell, Senior physician | +47 35003106 | anne.kristin.fell@sthf.no |
| Norway | |
| Sykehuset Telemark | Recruiting |
| Skien, Telemark, Norway, 3710 | |
| Contact: Svitlana Shkabura, Physician +4735003109 svitlana.shkabura@sthf.no | |
| Study Director: | Johny Kongerud, professor | Oslo University; Oslo University Hospital |
| Principal Investigator: | Berit Bakke, PhD | National Institute of Occupational Health |
| Principal Investigator: | Anne Kristin M Fell, MD | Sykehuset Telemark |
More Information
Publications:
| Responsible Party: | Henrik Høyvik, Head of Clinic, Sykehuset Telemark, Clinic for Medical Services |
| ClinicalTrials.gov Identifier: | NCT01337180 History of Changes |
| Other Study ID Numbers: | 5690.14 |
| Study First Received: | April 15, 2011 |
| Last Updated: | April 28, 2011 |
| Health Authority: | Norway: Regional Ethics Commitee |
Keywords provided by Sykehuset Telemark:
|
lung function respiratory symptoms dust inflammation prospective |
Additional relevant MeSH terms:
|
Inflammation Lung Diseases Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 22, 2013