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Preventing Respiratory Health Problems in Bakery Employees

Preventing Respiratory Health Problems in Bakery Employees.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01602237
Acronym
Baker2012
Enrollment
253
Registered
2012-05-18
Start date
2012-02-29
Completion date
2015-12-31
Last updated
2017-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Lung Disease, Rhinitis

Brief 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.

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.

Interventions

None listed

Sponsors

Haukeland University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Employed in a bakery for more than 6 months * and/or participant of the investigations done in 1999-2002 in 6 bakeries

Design outcomes

Primary

MeasureTime frameDescription
Forced Exhaled Volume in one second (FEV1)Change/decline from 1999-2002 to 2012The decline in FEV1 from 1999-2002 to 2012.

Secondary

MeasureTime frameDescription
Forced Vital Capacity (FVC)Each participant will be investigated once. Anticipated recruitment time for the whole cohort (study population I and II): about 10 months.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
Inflammation markers in nasal lavageEach participant will be investigated once. Anticipated recruitment time for the whole cohort (study population I and II): about 10 months.Measurement in nasal lavage of inflammation markers (albumin, tryptase, eosinophilic cationic protein) when at work (field study)
Specific IgEEach participant will be investigated once. Anticipated recruitment time for the whole cohort (study population I and II): about 10 months.In serum measurement of specific IgE to common airborne allergens, and allergens mainly found in bakeries
Skin reaction to prick testing with allergen extractsEach participant will be investigated once. Anticipated recruitment time for the whole cohort (study population I and II): about 10 months.Skin prick test with commercially available allergen extracts (common and occupational allergens in bakeries)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026