Airway Inflammation Among Workers in the Silicon Carbide Processing Industry

This study has been withdrawn prior to enrollment.
(The industry plant from which we should recruit was closed down.)
Sponsor:
Collaborators:
Oslo University Hospital
National Institute of Occupational Health, Norway
University of North Carolina
Information provided by (Responsible Party):
Anne Kristin M. Fell, Sykehuset Telemark
ClinicalTrials.gov Identifier:
NCT01337180
First received: April 15, 2011
Last updated: June 12, 2013
Last verified: June 2013
  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

Further study details as provided by Sykehuset Telemark:

Biospecimen Retention:   Samples With DNA

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.


Enrollment: 0
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
Study Population

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337180

Locations
Norway
Sykehuset Telemark
Skien, Telemark, Norway, 3710
Sponsors and Collaborators
Sykehuset Telemark
Oslo University Hospital
National Institute of Occupational Health, Norway
University of North Carolina
Investigators
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: Anne Kristin M. Fell, Consultant, Sykehuset Telemark
ClinicalTrials.gov Identifier: NCT01337180     History of Changes
Other Study ID Numbers: 5690.14
Study First Received: April 15, 2011
Last Updated: June 12, 2013
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 October 23, 2014