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

Completed

• Conditions: Airway Obstruction

• Registration Number: NCT00727714
• Lead Sponsor: Sykehuset Telemark

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).

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 Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-08-01
• Study First Posted: 2008-08-04
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Results First Submitted: 2015-11-17
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-13
• Last Update Submitted: 2016-04-13
• Results First Posted: 2016-05-20
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 Serum/Plasma Inflammatory Markers Between Baseline and 32 h	0-32h
Changes in FeNO Measurements Between Baseline (0h) and 32 h	0-32h

Trial Locations

Locations (1)

Sykehuset Telemark HF; 🇳🇴 Skien, Norway