Lung Function and Airway Inflammation in Portland Cement Workers (SPUTUM)

June 12, 2013 updated by: Anne Kristin M. Fell, Sykehuset Telemark

Airway Inflammation in Cement Dust Exposed Workers

The aim of the study is to examine inflammation in the airways and in peripheral blood, in workers in a cement plant i Norway.

Study Overview

Status

Completed

Conditions

Detailed Description

OBJECTIVE: Former studies have presented conflicting data on the association between exposure to Portland cement dust and respiratory effects. Our goal is to examine inflammation in the airways and in peripheral blood in subjects exposed to cement-dust.

METHODS: All non smoking, dust exposed, workers from one department in the largest cement plant in Norway, are invited to participate. The workers will perform spirometry and induced sputum (IS) after a period of regular work with cement dust exposure, and again after a minimum of 5 days without exposure. Information on respiratory symptoms, allergy and former respiratory disease will be given on a self-reported questionnaire. IS was performed and processed as described by Pin et al. Differential cell counts will be carried out. Inflammatory markers in induced sputum and in peripheral blood will be measured. We want to use a crossover design were the cases are used as their own controls, but we will also include external controls.

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Workers from Norways largest cement plant

Description

Inclusion Criteria:

  • Cement dust exposure
  • Non-smoker or ex-smoker >3 years

Exclusion Criteria:

  • Infectious disease during the last 3 weeks
  • Chronic airway disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of neutrophile cells in induced sputum
Time Frame: Before and after a period of exposure
A significantly higher percentage of neutrophils was observed in induced sputum samples from cement production workers collected during an exposed period compared with a nonexposed period and compared with external controls.
Before and after a period of exposure
Concentration of Interleukin 1beta in induced sputum
Time Frame: Before and after a period of exposure to cement production dust
The concentration of Interleukin 1beta was higher in the sputum of workers during an exposed period than that of the office workers or the external controls.
Before and after a period of exposure to cement production dust

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sykehuset Telemark

Collaborators

Rikshospitalet University Hospital
Helse Sor-Ost

Investigators

  • Study Chair: Johny Kongerud, MD, Phd,, Department of respiratory medicine, Radiumhospitalet-Rikshospitalet Medical Centre, Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

March 30, 2007

First Submitted That Met QC Criteria

April 2, 2007

First Posted (Estimate)

April 3, 2007

Study Record Updates

Last Update Posted (Estimate)

June 13, 2013

Last Update Submitted That Met QC Criteria

June 12, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STHF 5690.11, REK S-00166

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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