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

This study has been completed.
Sponsor:
Collaborators:
Rikshospitalet University Hospital
Helse Sor-Ost
Information provided by (Responsible Party):
Anne Kristin M. Fell, Sykehuset Telemark
ClinicalTrials.gov Identifier:
NCT00455377
First received: March 30, 2007
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

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
Airway Inflammation
Peripheral Blood Inflammation Markers
Cement Dust Exposure

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Airway Inflammation in Cement Dust Exposed Workers

Further study details as provided by Sykehuset Telemark:

Primary Outcome Measures:
  • Percentage of neutrophile cells in induced sputum [ Time Frame: Before and after a period of exposure ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Enrollment: 72
Study Start Date: March 2007
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 67 Years
Genders Eligible for Study:   Both
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
  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: 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
  More Information

Publications:
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
Study First Received: March 30, 2007
Last Updated: June 12, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Sykehuset Telemark:
Cement dust exposure
Induced sputum
Airway inflammation
Peripheral blood inflammation markers

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014