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Lung Function and Airway Inflammation in Portland Cement Workers (SPUTUM)

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ClinicalTrials.gov Identifier: NCT00455377
Recruitment Status : Completed
First Posted : April 3, 2007
Last Update Posted : June 13, 2013
Sponsor:
Collaborators:
Rikshospitalet University Hospital
Helse Sor-Ost
Information provided by (Responsible Party):
Anne Kristin M. Fell, Sykehuset Telemark

Brief Summary:
The aim of the study is to examine inflammation in the airways and in peripheral blood, in workers in a cement plant i Norway.

Condition or disease
Airway Inflammation Peripheral Blood Inflammation Markers Cement Dust Exposure

Detailed Description:

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
Time Perspective: Cross-Sectional
Official Title: Airway Inflammation in Cement Dust Exposed Workers
Study Start Date : March 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : December 2008



Primary Outcome Measures :
  1. 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.

  2. 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
Induced sputum samples and blood samples


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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Workers from Norways largest cement plant
Criteria

Inclusion Criteria:

  • Cement dust exposure
  • Non-smoker or ex-smoker >3 years

Exclusion Criteria:

  • Infectious disease during the last 3 weeks
  • Chronic airway disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00455377


Locations
Norway
Sykehuset Telemark
Skien, Telemark, Norway, N-3710
Sponsors and Collaborators
Sykehuset Telemark
Rikshospitalet University Hospital
Helse Sor-Ost
Investigators
Study Chair: Johny Kongerud, MD, Phd, Department of respiratory medicine, Radiumhospitalet-Rikshospitalet Medical Centre, Oslo

Publications of Results:
Responsible Party: Anne Kristin M. Fell, MD, PhD, Sykehuset Telemark
ClinicalTrials.gov Identifier: NCT00455377     History of Changes
Other Study ID Numbers: STHF 5690.11, REK S-00166
First Posted: April 3, 2007    Key Record Dates
Last Update Posted: June 13, 2013
Last Verified: June 2013

Keywords provided by Anne Kristin M. Fell, Sykehuset Telemark:
Cement dust exposure
Induced sputum
Airway inflammation
Peripheral blood inflammation markers

Additional relevant MeSH terms:
Inflammation
Pathologic Processes