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Completed

NCT Number: NCT01602237

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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

  2. 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.

    Measurement in nasal lavage of inflammation markers (albumin, tryptase, eosinophilic cationic protein) when at work (field study)

  3. 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.

    In serum measurement of specific IgE to common airborne allergens, and allergens mainly found in bakeries

  4. 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.

    Skin prick test with commercially available allergen extracts (common and occupational allergens in bakeries)

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

Preventing Respiratory Health Problems in Bakery Employees.

Acronym: Baker2012

Important dates

Study start
2012
Primary completion
2012
Study completion
2015
First posted
May 18, 2012
Registry last updated
Aug 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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