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

Circulating Inflammatory Markers, Exhaled NO and Lung Function in Cement Production Workers; a Cross-shifts Study

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).

Study Overview

• Status: Completed
• Conditions: Airway Obstruction

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).

• Study Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• Norway
  • Skien, Norway, N-3710
    • Sykehuset Telemark HF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All employees of two Norwegian cement production plants are invited to participate.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Lung Function Measurements During One Work Shift (6-8h)	Changes in lung function measurements during one work shift (6-8h), spirometry and gass diffusion capacity	baseline and 6-8h

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in FeNO Measurements During One Shift (6-8h)	baseline and 6-8h
Changes in Serum/Plasma Inflammatory Markers During One Shift (6-8h)	Baseline and 6-8h
Changes in FeNO Measurements Between Baseline (0h) and 32 h	0-32h
Changes in Serum/Plasma Inflammatory Markers Between Baseline and 32 h	0-32h

Collaborators and Investigators

• Sponsor: Sykehuset Telemark
• Collaborators: National Institute for Occupational Safety and Health (NIOSH/CDC); Rikshospitalet University Hospital
• 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

Publications and helpful links

General Publications

• Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
• American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30. doi: 10.1164/rccm.200406-710ST. No abstract available.
• Macintyre N, Crapo RO, Viegi G, Johnson DC, van der Grinten CP, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, Gustafsson P, Hankinson J, Jensen R, McKay R, Miller MR, Navajas D, Pedersen OF, Pellegrino R, Wanger J. Standardisation of the single-breath determination of carbon monoxide uptake in the lung. Eur Respir J. 2005 Oct;26(4):720-35. doi: 10.1183/09031936.05.00034905. No abstract available.
• Abrons HL, Petersen MR, Sanderson WT, Engelberg AL, Harber P. Symptoms, ventilatory function, and environmental exposures in Portland cement workers. Br J Ind Med. 1988 Jun;45(6):368-75. doi: 10.1136/oem.45.6.368. Erratum In: Br J Ind Med 1988 Oct;45(10):720.
• Fell AK, Thomassen TR, Kristensen P, Egeland T, Kongerud J. Respiratory symptoms and ventilatory function in workers exposed to portland cement dust. J Occup Environ Med. 2003 Sep;45(9):1008-14. doi: 10.1097/01.jom.0000083036.56116.9d.
• Ali BA, Ballal SG, Albar AA, Ahmed HO. Post-shift changes in pulmonary function in a cement factory in eastern Saudi Arabia. Occup Med (Lond). 1998 Nov;48(8):519-22. doi: 10.1093/occmed/48.8.519.
• Larsson K. Aspects on pathophysiological mechanisms in COPD. J Intern Med. 2007 Sep;262(3):311-40. doi: 10.1111/j.1365-2796.2007.01837.x.
• Raulf-Heimsoth M, Pesch B, Schott K, Kappler M, Preuss R, Marczynski B, Angerer J, Rihs HP, Hahn JU, Merget R, Bruning T. Irritative effects of fumes and aerosols of bitumen on the airways: results of a cross-shift study. Arch Toxicol. 2007 Jan;81(1):35-44. doi: 10.1007/s00204-006-0115-z. Epub 2006 May 19.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: July 30, 2008
• First Submitted That Met QC Criteria: August 1, 2008
• First Posted (Estimate): August 4, 2008

Study Record Updates

• Last Update Posted (Estimate): May 20, 2016
• Last Update Submitted That Met QC Criteria: April 13, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Exhaled nitric oxide; Cement dust exposure; Cross-shift study; Lung function indices; Serum inflammatory markers
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction
• Other Study ID Numbers: STHF 5690.11, REK S-08083a

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.