Preventing Respiratory Health Problems in Bakery Employees (Baker2012)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01602237
First received: March 5, 2012
Last updated: January 5, 2014
Last verified: January 2014
  Purpose

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.


Condition
Chronic Obstructive Lung Disease
Rhinitis

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Preventing Respiratory Health Problems in Bakery Employees.

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Forced Exhaled Volume in one second (FEV1) [ Time Frame: Change/decline from 1999-2002 to 2012 ] [ Designated as safety issue: No ]
    The decline in FEV1 from 1999-2002 to 2012.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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 lavage [ Time Frame: Each participant will be investigated once. Anticipated recruitment time for the whole cohort (study population I and II): about 10 months. ] [ Designated as safety issue: No ]
    Measurement in nasal lavage of inflammation markers (albumin, tryptase, eosinophilic cationic protein) when at work (field study)

  • 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. ] [ Designated as safety issue: No ]
    In serum measurement of specific IgE to common airborne allergens, and allergens mainly found in bakeries

  • 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. ] [ Designated as safety issue: No ]
    Skin prick test with commercially available allergen extracts (common and occupational allergens in bakeries)


Biospecimen Retention:   Samples Without DNA

Serum, Nasal lavage fluid (without cells)


Enrollment: 253
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Bakery workers

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
Criteria

Inclusion Criteria:

  • Employed in a bakery for more than 6 months
  • and/or participant of the investigations done in 1999-2002 in 6 bakeries
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602237

Locations
Norway
Dept. of Occupational Medicine, Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Torgeir Storaas, PhD, MD Haukeland University Hospital
Study Director: Tor B Aasen, MD Haukeland University Hospital
  More Information

Publications:
Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01602237     History of Changes
Other Study ID Numbers: 2011/2449
Study First Received: March 5, 2012
Last Updated: January 5, 2014
Health Authority: Norway: Regional Ethics Commitee

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Rhinitis
Lung Diseases, Obstructive
Respiratory Tract Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 22, 2014