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

NCT00727714 | Completed Results

• 1 other identifier: STHF 5690.11, REK S-08083a
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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).

Conditions

Airway Obstruction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Employees from a Norwegian cement production plant

You may not qualify if:

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

Sponsors & Collaborators

• Sykehuset Telemark: lead
• Rikshospitalet University Hospital: collaborator
• National Institute for Occupational Safety and Health (NIOSH/CDC): collaborator

Study Sites (1)

Sykehuset Telemark HF

Skien, N-3710, Norway

Location

Related Publications (8)

• 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.

  PMID: 3260798 BACKGROUND

• 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.

  PMID: 14506344 BACKGROUND

• 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.

  PMID: 10024727 BACKGROUND

• 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.

  PMID: 17697154 BACKGROUND

• 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.

  PMID: 16710697 BACKGROUND

• 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.

  PMID: 16055882 BACKGROUND

• 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.

  PMID: 16204605 BACKGROUND

• 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.

  PMID: 15817806 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood serum

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Anne Kristin M. Fell, MD, PhD
• Organization: Telemark Hospital

annfel@sthf.no

+4735003106

Study Officials

• Johny Kongerud, MD, PhD

  Rikshospitalet University Hospital

  STUDY CHAIR

• Helge Kjuus, MD, PhD

  National Institute of occupational Health, NIOH

  STUDY CHAIR

• Marit Skogstad, MD, PhD

  National Institute of occupational Health, NIOH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician, MD, PhD

Study Record Dates

• First Submitted: July 30, 2008
• First Posted: August 4, 2008
• Study Start: April 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: May 20, 2016
• Results First Posted: May 20, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)