Chronic Obstructive Lung DiseaseBaker2012NCT01602237
Preventing Respiratory Health Problems in Bakery Employees
An observational study of Chronic Obstructive Lung Disease and Rhinitis, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The study is a follow-up of investigations done in the years 1999-2002 in bakery employees. The main purposes are to look at the associations between flour dust exposure and respiratory disease, and to find out the best ways to reduce the flour dust levels in the working environment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Lung Disease, Rhinitis
- How many people
- 253 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2012to Dec 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. All the employees in 5 bakeries investigated in 1999-2002 (one of the original 6 bakeries has fused with one of the others) 2. All the employees in additional 2 bakeries located in the same Hordaland county, Norway, as the other 5 bakeries
Who may be able to join
- Employed in a bakery for more than 6 months
- and/or participant of the investigations done in 1999-2002 in 6 bakeries
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Dept. of Occupational Medicine, Haukeland University Hospital
Bergen, 5021
About this study
Official title: Preventing Respiratory Health Problems in Bakery Employees.
The study is a follow-up of investigations done in the years 1999-2002 in bakery employees. The main purposes are to look at the associations between flour dust exposure and respiratory disease, and to find out the best ways to reduce the flour dust levels in the working environment.
Read the detailed description
Background and Methods:
Supported by the The Confederation of Norwegian Enterprise (CNBI) Working Environment Fund a follow-up study of 184 bakery workers in 5 bakeries was done in 2012, appr. 10 years after a similar study in 1999-2002. In addition a cross-sectional study in 2 other bakeries (one 'bread-factory', and a traditional bakery with three small bake shops) was added.
Altogether 253 participants, among them 61 former bakery workers, were investigated with use of questionnaires, allergy-testing (skin prick testing, and blood samples for specific IgE and total IgE), spirometry with reversibility testing, exhaled NO-measurement, and nasal measurements.
As in 1999-2002 an extensive exposure assessment was performed including personal samples of total dust (Gelman), inhalable dust (PAS6), as well as direct reading measurements of dust (Dust Track). A Job Exposure Matrix (JEM) was created enabling each participant to be assigned an exposure value of probable mean daily flour-dust exposure based on work-tasks and bakery.
Aim of study:
- Follow-up of the participants in the 1999-2002 study, both still active bakery workers and former workers, on health-status focusing on respiratory disease, sensitization to common and occupational allergens, level of sick-leave and reasons for quitting as a baker.
- Inclusion of 'new' bakery workers into the cohort as a cross-sectional study, and to compare health-status in two cross-sectional cohorts.
- To assess personal exposure to flour-dust among workers in 7 bakeries, as part of the cross-sectional study described above.
- To identify implemented flour-dust exposure reduction measures in bakeries participating in 1999-2002, and to assess the potential impact of these measures on the exposure to flour dust.
- Conditions
- Chronic Obstructive Lung Disease, Rhinitis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bakery workers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Exhaled Volume in one second (FEV1)
The decline in FEV1 from 1999-2002 to 2012.
Measured: Change/decline from 1999-2002 to 2012
Secondary outcomes (4)
Forced Vital Capacity (FVC)
Before and after salbutamol-inhalation. Post-bronchodilatory measurements of FEV1 and FVC to measure the prevalence of chronic obstructive lung disease in a cohort of bakery workers
Measured: Each participant will be investigated once. Anticipated recruitment time for the whole cohort (study population I and II): about 10 months.
Inflammation markers in nasal lavage
Measurement in nasal lavage of inflammation markers (albumin, tryptase, eosinophilic cationic protein) when at work (field study)
Measured: Each participant will be investigated once. Anticipated recruitment time for the whole cohort (study population I and II): about 10 months.
Specific IgE
In serum measurement of specific IgE to common airborne allergens, and allergens mainly found in bakeries
Measured: Each participant will be investigated once. Anticipated recruitment time for the whole cohort (study population I and II): about 10 months.
Skin reaction to prick testing with allergen extracts
Skin prick test with commercially available allergen extracts (common and occupational allergens in bakeries)
Measured: Each participant will be investigated once. Anticipated recruitment time for the whole cohort (study population I and II): about 10 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torgeir Storaas, PhD, MD, Principal investigator, Haukeland University HospitalTor B Aasen, MD, Study director, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602237
- Sponsor's protocol ID
- 2011/2449
- Acronym
- Baker2012
- Status last verified
- Aug 2017
- First submitted
- 5 Mar 2012
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Storaas T, Irgens A, Florvaag E, Steinsvag SK, Ardal L, Do TV, Greiff L, Aasen TB. Bronchial responsiveness in bakery workers: relation to airway symptoms, IgE sensitization, nasal indices of inflammation, flour dust exposure and smoking. Clin Physiol Funct Imaging. 2007 Sep;27(5):327-34. doi: 10.1111/j.1475-097X.2007.00755.x.
PubMed 17697030Storaas T, Ardal L, Van Do T, Florvaag E, Steinsvag SK, Irgens A, Aasen TB, Greiff L. Nasal indices of eosinophilic and exudative inflammation in bakery-workers. Clin Physiol Funct Imaging. 2007 Jan;27(1):23-9. doi: 10.1111/j.1475-097X.2007.00707.x.
PubMed 17204034Storaas T, Steinsvag SK, Florvaag E, Irgens A, Aasen TB. Occupational rhinitis: diagnostic criteria, relation to lower airway symptoms and IgE sensitization in bakery workers. Acta Otolaryngol. 2005 Nov;125(11):1211-7. doi: 10.1080/00016480510044205.
PubMed 16353405Kirkeleit J, Hollund BE, Riise T, Eduard W, Bratveit M, Storaas T. Bakers' exposure to flour dust. J Occup Environ Hyg. 2017 Feb;14(2):81-91. doi: 10.1080/15459624.2016.1225156.
PubMed 27540715
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Respiratory Health Problems in Bakery Employees.
- ClinicalTrials.gov ID
- NCT01602237
- Acronym / sponsor ID
- Baker2012 / 2011/2449
- Conditions
- Chronic Obstructive Lung Disease, Rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 May 2012 (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 study is a follow-up of investigations done in the years 1999-2002 in bakery employees. The main purposes are to look at the associations between flour dust exposure and respiratory disease, and to find out the best ways to reduce the flour dust levels in the working environment.
Detailed description
Background and Methods:
Supported by the The Confederation of Norwegian Enterprise (CNBI) Working Environment Fund a follow-up study of 184 bakery workers in 5 bakeries was done in 2012, appr. 10 years after a similar study in 1999-2002. In addition a cross-sectional study in 2 other bakeries (one 'bread-factory', and a traditional bakery with three small bake shops) was added.
Altogether 253 participants, among them 61 former bakery workers, were investigated with use of questionnaires, allergy-testing (skin prick testing, and blood samples for specific IgE and total IgE), spirometry with reversibility testing, exhaled NO-measurement, and nasal measurements.
As in 1999-2002 an extensive exposure assessment was performed including personal samples of total dust (Gelman), inhalable dust (PAS6), as well as direct reading measurements of dust (Dust Track). A Job Exposure Matrix (JEM) was created enabling each participant to be assigned an exposure value of probable mean daily flour-dust exposure based on work-tasks and bakery.
Aim of study:
- Follow-up of the participants in the 1999-2002 study, both still active bakery workers and former workers, on health-status focusing on respiratory disease, sensitization to common and occupational allergens, level of sick-leave and reasons for quitting as a baker.
- Inclusion of 'new' bakery workers into the cohort as a cross-sectional study, and to compare health-status in two cross-sectional cohorts.
- To assess personal exposure to flour-dust among workers in 7 bakeries, as part of the cross-sectional study described above.
- To identify implemented flour-dust exposure reduction measures in bakeries participating in 1999-2002, and to assess the potential impact of these measures on the exposure to flour dust.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bakery workers | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. All the employees in 5 bakeries investigated in 1999-2002 (one of the original 6 bakeries has fused with one of the others) 2. All the employees in additional 2 bakeries located in the same Hordaland county, Norway, as the other 5 bakeries
Key inclusion criteria (2 listed)
- Employed in a bakery for more than 6 months
- and/or participant of the investigations done in 1999-2002 in 6 bakeries
Key exclusion criteria (0 listed)
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
Forced Exhaled Volume in one second (FEV1)
Time frame: Change/decline from 1999-2002 to 2012
The decline in FEV1 from 1999-2002 to 2012.
4 secondary outcomes
Forced Vital Capacity (FVC)
Time frame: Each participant will be investigated once. Anticipated recruitment time for the whole cohort (study population I and II): about 10 months.
Inflammation markers in nasal lavage
Time frame: Each participant will be investigated once. Anticipated recruitment time for the whole cohort (study population I and II): about 10 months.
Specific IgE
Time frame: Each participant will be investigated once. Anticipated recruitment time for the whole cohort (study population I and II): about 10 months.
Skin reaction to prick testing with allergen extracts
Time frame: Each participant will be investigated once. Anticipated recruitment time for the whole cohort (study population I and II): about 10 months.
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 14 Aug 2017.
- Background: PubMed 17697030Storaas T, Irgens A, Florvaag E, Steinsvag SK, Ardal L, Do TV, Greiff L, Aasen TB. Bronchial responsiveness in bakery workers: relation to airway symptoms, IgE sensitization, nasal indices of inflammation, flour dust exposure and smoking. Clin Physiol Funct Imaging. 2007 Sep;27(5):327-34. doi: 10.1111/j.1475-097X.2007.00755.x.
- Background: PubMed 17204034Storaas T, Ardal L, Van Do T, Florvaag E, Steinsvag SK, Irgens A, Aasen TB, Greiff L. Nasal indices of eosinophilic and exudative inflammation in bakery-workers. Clin Physiol Funct Imaging. 2007 Jan;27(1):23-9. doi: 10.1111/j.1475-097X.2007.00707.x.
- Background: PubMed 16353405Storaas T, Steinsvag SK, Florvaag E, Irgens A, Aasen TB. Occupational rhinitis: diagnostic criteria, relation to lower airway symptoms and IgE sensitization in bakery workers. Acta Otolaryngol. 2005 Nov;125(11):1211-7. doi: 10.1080/00016480510044205.
- Results publication: PubMed 27540715Kirkeleit J, Hollund BE, Riise T, Eduard W, Bratveit M, Storaas T. Bakers' exposure to flour dust. J Occup Environ Hyg. 2017 Feb;14(2):81-91. doi: 10.1080/15459624.2016.1225156.
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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.
Torgeir Storaas, PhD, MD principal investigator
Haukeland University Hospital
Tor B Aasen, MD study director
Haukeland University Hospital
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 Chronic Obstructive Lung Disease and Rhinitis, run by Haukeland University Hospital 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 0 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 14 Aug 2017. 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?
Forced Exhaled Volume in one second (FEV1) (time frame: Change/decline from 1999-2002 to 2012). 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 NCT01602237, which also lists 4 linked publications.
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 14 Aug 2017.