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Preventing Respiratory Health Problems in Bakery Employees (Baker2012)

This study is currently recruiting participants.
Verified May 2012 by Haukeland University Hospital
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01602237
First received: March 5, 2012
Last updated: May 16, 2012
Last verified: May 2012
History of Changes
  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:

U.S. FDA Resources

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)


Estimated Enrollment: 300
Study Start Date: February 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Bakery workers

  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 bakery has fused with one of the others)
  2. All the employees in additional 5 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602237

Contacts
Contact: Torgeir Storaas, PhD, MD 4741414726 torgeir.storaas@helse-bergen.no

Locations
Norway
Dept. of Occupational Medicine, Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Torgeir Storaas, PhD, MD     4741414726     torgeir.storaas@helse-bergen.no    
Principal Investigator: Torgeir Storaas, PhD, MD            
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: May 16, 2012
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 June 18, 2013