Lung Function and Inflammatory Markers in Cement Dust Exposed Workers: A Cross-shifts Study (LIS)

This study has been completed.
Sponsor:
Collaborators:
Rikshospitalet University Hospital
National Institute for Occupational Safety and Health (NIOSH/CDC)
Information provided by (Responsible Party):
Anne Kristin M. Fell, Sykehuset Telemark
ClinicalTrials.gov Identifier:
NCT00727714
First received: July 30, 2008
Last updated: April 13, 2016
Last verified: April 2016
  Purpose
The aim of the study is to examine possible changes in lung function, nitric oxide levels and systemic inflammatory markers in cement dust exposed workers, during one shift (6-8 hours).

Condition
Airway Obstruction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Circulating Inflammatory Markers, Exhaled NO and Lung Function in Cement Production Workers; a Cross-shifts Study

Resource links provided by NLM:


Further study details as provided by Sykehuset Telemark:

Primary Outcome Measures:
  • Changes in Lung Function Measurements During One Work Shift (6-8h) [ Time Frame: baseline and 6-8h ] [ Designated as safety issue: No ]
    Changes in lung function measurements during one work shift (6-8h), spirometry and gass diffusion capacity


Secondary Outcome Measures:
  • Changes in FeNO Measurements During One Shift (6-8h) [ Time Frame: baseline and 6-8h ] [ Designated as safety issue: No ]
  • Changes in Serum/Plasma Inflammatory Markers During One Shift (6-8h) [ Time Frame: Baseline and 6-8h ] [ Designated as safety issue: No ]
  • Changes in FeNO Measurements Between Baseline (0h) and 32 h [ Time Frame: 0-32h ] [ Designated as safety issue: No ]
  • Changes in Serum/Plasma Inflammatory Markers Between Baseline and 32 h [ Time Frame: 0-32h ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Whole blood serum

Enrollment: 95
Study Start Date: April 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVE:

Cement dust is suspected to be one of the main factors causing increased mortality among workers not only in the cement production industry, but also in the construction industry worldwide. Our aim is to examine possible changes in lung function, nitric oxide levels and systemic inflammatory markers in cement dust exposed workers, during one shift (6-8 hours).

METHODS:

All employees from Norwegian cement plants, are invited to participate. The workers will perform spirometry, single-breath determination of carbon monoxide uptake, blood samples before and after a working shift of 6-8 hours, and again after 24 hours. Information on respiratory symptoms, allergy and former respiratory disease as well as exposure information will be given on a self-reported questionnaire. Changes in lung function indices, nitric oxide levels and serum inflammatory markers will be calculated. Nitric oxide will only be measured in non-smokers. We will compare cement dust exposed workers with low-level or non-exposed workers (controls).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All employees of two Norwegian cement production plants are invited to participate.
Criteria

Inclusion Criteria:

  • Employees from a Norwegian cement production plant

Exclusion Criteria:

  • Exhaled nitric oxide measurements: smokers
  • Substantial previous work in quarry or as a miner
  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: NCT00727714

Locations
Norway
Sykehuset Telemark HF
Skien, Norway, N-3710
Sponsors and Collaborators
Sykehuset Telemark
Rikshospitalet University Hospital
National Institute for Occupational Safety and Health (NIOSH/CDC)
Investigators
Study Chair: Johny Kongerud, MD, PhD Rikshospitalet University Hospital
Study Chair: Helge Kjuus, MD, PhD National Institute of occupational Health, NIOH
Principal Investigator: Marit Skogstad, MD, PhD National Institute of occupational Health, NIOH
  More Information

Publications:

Responsible Party: Anne Kristin M. Fell, Senior physician, MD, PhD, Sykehuset Telemark
ClinicalTrials.gov Identifier: NCT00727714     History of Changes
Other Study ID Numbers: STHF 5690.11, REK S-08083a 
Study First Received: July 30, 2008
Results First Received: November 17, 2015
Last Updated: April 13, 2016
Health Authority: Norway: Norwegian Social Science Data Services
Individual Participant Data  
Plan to Share IPD: No
Plan Description: The individual data is no longer available, due to regulations in Norway requiering individual data to be deleted 5 years after the study was compleeted.

Keywords provided by Sykehuset Telemark:
Cement dust exposure
Cross-shift study
Lung function indices
Exhaled nitric oxide
Serum inflammatory markers

Additional relevant MeSH terms:
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 25, 2016