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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01096537
Other study ID # 2008-A00622-53
Secondary ID
Status Completed
Phase N/A
First received March 10, 2010
Last updated July 4, 2016
Start date December 2008
Est. completion date June 2010

Study information

Verified date March 2016
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority France: French Data Protection Authority
Study type Observational

Clinical Trial Summary

Background: Occupational exposures are thought to be responsible for 10-15% of new-onset asthma cases in adults, with disparities across sectors. Because most of the data are derived from registries and cross-sectional studies, little is known about incidence of occupational asthma (OA) during the first years after inception of exposure. This study focuses on this early asthma onset period among young workers in the bakery, pastry making and hairdressing sectors in order to assess early incidence of OA in these "at risk" occupations according to exposure duration, and to identify risk factors of OA.

Methods: This study is a longitudinal retrospective study with a nested case-control to identify risk factors of OA. The assessment of incidence evolution is made by exploring a series of promotions (or retrospective cohorts) with increasing duration since at work. The study population is composed of subjects who graduated between 2001 and 2006 in sectors where they experience exposure to organic or inorganic allergenic or irritant compounds (with an objective of 150 subjects by year) and 250 young workers with no specific occupational exposure.

This study is a descriptive, monocentric, longitudinal and retrospective study with cross-sectional measurements.


Recruitment information / eligibility

Status Completed
Enrollment 866
Est. completion date June 2010
Est. primary completion date January 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- for the exposed group: to be graduated between 2001 and 2006 from nine vocational schools in Lorraine, North-Eastern France

- for the "non-exposed" group: to be graduated in 2001 in the sale or the food sectors (butcher, pork butcher, caterer, cook job,…) from the same vocational schools

Exclusion Criteria:

- asthma diagnosed before apprenticeship

- for the "non-exposed" group: to have worked previously or later in a sector at risk with OA

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU Nancy Nancy

Sponsors (3)

Lead Sponsor Collaborator
Central Hospital, Nancy, France Institut National de la Santé Et de la Recherche Médicale, France, University of Nancy

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary The early incidence of OA among young workers according to their sector of activity and exposure duration. 3-6 months after tle last inclusion No
Secondary The identification of risk factors of OA. 3-6 months after the last inclusion No
See also
  Status Clinical Trial Phase
Terminated NCT01783873 - Comparative Study of Pathophysiological Mechanisms and Bronchial Response in Occupational Asthma to Wheat Flour and Quaternary Ammonium Compounds During Standardized Bronchial Provocation Tests N/A
Recruiting NCT03568305 - Characterization of Phenotypes of Occupational Asthma