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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00727714

Recruitment Status : Completed

First Posted : August 4, 2008

Results First Posted : May 20, 2016

Last Update Posted : May 20, 2016

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

Study Description

Brief Summary:

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 or disease
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 Design

Layout table for study information

Study Type :	Observational
Actual Enrollment :	95 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Circulating Inflammatory Markers, Exhaled NO and Lung Function in Cement Production Workers; a Cross-shifts Study
Study Start Date :	April 2008
Actual Primary Completion Date :	January 2009
Actual Study Completion Date :	January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Choking

Genetic and Rare Diseases Information Center resources: Oculocerebral Syndrome With Hypopigmentation

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Changes in Lung Function Measurements During One Work Shift (6-8h) [ Time Frame: baseline and 6-8h ]
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 ]
Changes in Serum/Plasma Inflammatory Markers During One Shift (6-8h) [ Time Frame: Baseline and 6-8h ]
Changes in FeNO Measurements Between Baseline (0h) and 32 h [ Time Frame: 0-32h ]
Changes in Serum/Plasma Inflammatory Markers Between Baseline and 32 h [ Time Frame: 0-32h ]

Biospecimen Retention: Samples With DNA

Whole blood serum

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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): NCT00727714

Locations

Layout table for location information

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

Layout table for investigator information

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:

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. 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.

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.

Larsson K. Aspects on pathophysiological mechanisms in COPD. J Intern Med. 2007 Sep;262(3):311-40. Review.

Raulf-Heimsoth M, Pesch B, Schott K, Kappler M, Preuss R, Marczynski B, Angerer J, Rihs HP, Hahn JU, Merget R, Brüning 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. Epub 2006 May 19.

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.

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.

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.

Layout table for additonal information

Responsible Party:	Anne Kristin M. Fell, Senior physician, MD, PhD, Sykehuset Telemark
ClinicalTrials.gov Identifier:	NCT00727714
Other Study ID Numbers:	STHF 5690.11, REK S-08083a
First Posted:	August 4, 2008 Key Record Dates
Results First Posted:	May 20, 2016
Last Update Posted:	May 20, 2016
Last Verified:	April 2016
Individual Participant Data (IPD) Sharing Statement:
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 Anne Kristin M. Fell, Sykehuset Telemark:


Cement dust exposure Cross-shift study Lung function indices Exhaled nitric oxide Serum inflammatory markers

Additional relevant MeSH terms:

Layout table for MeSH terms

Airway Obstruction Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases

To Top