Airway InflammationSPUTUMNCT00455377
Lung Function and Airway Inflammation in Portland Cement Workers
An observational study of Airway Inflammation and Peripheral Blood Inflammation Markers, run by Sykehuset Telemark at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Inflammation, Peripheral Blood Inflammation Markers, Cement Dust Exposure
- How many people
- 72 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2007to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Workers from Norways largest cement plant
Who may be able to join
- Cement dust exposure
- Non-smoker or ex-smoker >3 years
Who cannot join
- Infectious disease during the last 3 weeks
- Chronic airway disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- Cement dust exposure, Induced sputum, Airway inflammation, Peripheral blood inflammation markers
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before and after a period of exposure to cement production dust
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Telemark
- Sponsor type
- Other government
- Collaborators
- Rikshospitalet University Hospital, Helse Sor-Ost
- Responsible party
- Principal investigator, Anne Kristin M. Fell, Sykehuset Telemark
- Investigators
- Johny Kongerud, MD, Phd,, Study chair, Department of respiratory medicine, Radiumhospitalet-Rikshospitalet Medical Centre, Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455377
- Sponsor's protocol ID
- STHF 5690.11, REK S-00166
- Acronym
- SPUTUM
- Status last verified
- Jun 2013
- First submitted
- 30 Mar 2007
- Last updated
- 13 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19854695
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Inflammation in Cement Dust Exposed Workers
- ClinicalTrials.gov ID
- NCT00455377
- Acronym / sponsor ID
- SPUTUM / STHF 5690.11, REK S-00166
- Keywords
- Cement dust exposure, Induced sputum, Airway inflammation, Peripheral blood inflammation markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Sykehuset TelemarkOther government
- Collaborators
- Rikshospitalet University Hospital, Helse Sor-Ost
- Study start
- Mar 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 3 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to examine inflammation in the airways and in peripheral blood, in workers in a cement plant i Norway.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Workers from Norways largest cement plant
Key inclusion criteria (2 listed)
- Cement dust exposure
- Non-smoker or ex-smoker >3 years
Key exclusion criteria (2 listed)
- Infectious disease during the last 3 weeks
- Chronic airway disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2013.
- Results publication: PubMed 19854695Fell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johny Kongerud, MD, Phd, study chair
Department of respiratory medicine, Radiumhospitalet-Rikshospitalet Medical Centre, Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Inflammation and Peripheral Blood Inflammation Markers, run by Sykehuset Telemark at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of neutrophile cells in induced sputum (time frame: Before and after a period of exposure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00455377, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2013.