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

Systemic Inflammation Clinical Trial

— LIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00727714
• Other study ID #: STHF 5690.11, REK S-08083a
• Status: Completed
• Phase: N/A
• First received: July 30, 2008
• Last updated: April 9, 2010
• Start date: April 2008
• Est. completion date: January 2009

Study information

• Verified date: April 2010
• Source: Sykehuset Telemark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Airway Inflammation
• Cement Dust Exposure
• Inflammation
• Systemic Inflammation

Locations

Country	Name	City	State
Norway	Sykehuset Telemark HF	Skien

Sponsors (3)

Lead Sponsor	Collaborator
Sykehuset Telemark	National Institute for Occupational Safety and Health (NIOSH/CDC), Rikshospitalet University Hospital

Country where clinical trial is conducted

Norway, 

References & 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. Erratum in: Br J Ind Med 1988 Oct;45(10):720. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in lung function measurements during one work shift (6-8h)	Spirometry and gass diffusion	cross-shift 6-8h	No
Secondary	Changes in FeNO measurements during one shift (6-8h)		cross-shift 6-8h	No
Secondary	Changes in serum/plasma inflammatory markers during one shift (6-8h)		Cross shift: 6-8h	No
Secondary	Changes in FeNO measurements between baseline (0h) and 32 h		0-32h	No
Secondary	Changes in serum/plasma inflammatory markers between baseline and 32 h		0-32h	No