Overview

This trial is active, not recruiting.

Conditions chronic obstructive lung disease, rhinitis
Sponsor Haukeland University Hospital
Start date February 2012
End date December 2012
Trial size 253 participants
Trial identifier NCT01602237, 2011/2449

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Arm

Primary Outcomes

Measure
Forced Exhaled Volume in one second (FEV1)
time frame: Change/decline from 1999-2002 to 2012

Secondary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Preventing Respiratory Health Problems in Bakery Employees.
Principal investigator Torgeir Storaas, PhD, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Haukeland University Hospital.