Lung Function and Airway Inflammation in Portland Cement Workers (SPUTUM)
|ClinicalTrials.gov Identifier: NCT00455377|
Recruitment Status : Completed
First Posted : April 3, 2007
Last Update Posted : June 13, 2013
|Condition or disease|
|Airway Inflammation Peripheral Blood Inflammation Markers Cement Dust Exposure|
OBJECTIVE: Former studies have presented conflicting data on the association between exposure to Portland cement dust and respiratory effects. Our goal is to examine inflammation in the airways and in peripheral blood in subjects exposed to cement-dust.
METHODS: All non smoking, dust exposed, workers from one department in the largest cement plant in Norway, are invited to participate. The workers will perform spirometry and induced sputum (IS) after a period of regular work with cement dust exposure, and again after a minimum of 5 days without exposure. Information on respiratory symptoms, allergy and former respiratory disease will be given on a self-reported questionnaire. IS was performed and processed as described by Pin et al. Differential cell counts will be carried out. Inflammatory markers in induced sputum and in peripheral blood will be measured. We want to use a crossover design were the cases are used as their own controls, but we will also include external controls.
|Study Type :||Observational|
|Actual Enrollment :||72 participants|
|Observational Model:||Case Control|
|Official Title:||Airway Inflammation in Cement Dust Exposed Workers|
|Study Start Date :||March 2007|
|Primary Completion Date :||October 2008|
|Study Completion Date :||December 2008|
- Percentage of neutrophile cells in induced sputum [ Time Frame: Before and after a period of exposure ]A significantly higher percentage of neutrophils was observed in induced sputum samples from cement production workers collected during an exposed period compared with a nonexposed period and compared with external controls.
- Concentration of Interleukin 1beta in induced sputum [ Time Frame: Before and after a period of exposure to cement production dust ]The concentration of Interleukin 1beta was higher in the sputum of workers during an exposed period than that of the office workers or the external controls.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00455377
|Skien, Telemark, Norway, N-3710|
|Study Chair:||Johny Kongerud, MD, Phd,||Department of respiratory medicine, Radiumhospitalet-Rikshospitalet Medical Centre, Oslo|