NCT00455377

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 3, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 13, 2013

Status Verified

June 1, 2013

Enrollment Period

1.6 years

First QC Date

March 30, 2007

Last Update Submit

June 12, 2013

Conditions

Airway InflammationPeripheral Blood Inflammation MarkersCement Dust Exposure

Keywords

Cement dust exposureInduced sputumAirway inflammationPeripheral blood inflammation markers

Outcome Measures

Primary Outcomes (2)

  • Percentage of neutrophile cells in induced sputum

    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

    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

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Workers from Norways largest cement plant

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sykehuset Telemark

Skien, Telemark, N-3710, Norway

Location

Related Publications (1)

  • Fell AK, Sikkeland LI, Svendsen MV, Kongerud J. Airway inflammation in cement production workers. Occup Environ Med. 2010 Jun;67(6):395-400. doi: 10.1136/oem.2009.047852. Epub 2009 Oct 22.

    PMID: 19854695RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Induced sputum samples and blood samples

Study Officials

  • Johny Kongerud, MD, Phd,

    Department of respiratory medicine, Radiumhospitalet-Rikshospitalet Medical Centre, Oslo

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 30, 2007

First Posted

April 3, 2007

Study Start

March 1, 2007

Primary Completion

October 1, 2008

Study Completion

December 1, 2008

Last Updated

June 13, 2013

Record last verified: 2013-06

Locations

NO(1)