Clincosm LogoSign in Get a demo

BALISTIC 2: Characterization of Professional COPD Related to Exposure to Organic Dust - Mean Follow up at 6 Years

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03468101
Collaborator
(none)
200
Enrollment
1
Location
50.4
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of the BALISTIC research program is to characterize COPD related to organic particles (of which the model is agricultural COPD) in comparison with tobacco-related COPD, at the clinical, functional (at rest and exercise), inflammatory and physiopathological level.

The cross-sectional step BALISTIC 1 made it possible to include 400 patients between 2011 and 2015, and to identify approximately 100 dairy farmers COPD and 100 non-dairy farmers COPD (tobacco COPD). Preliminary results, as well as those of an ancillary study that included a group of subjects exposed to mineral dust and fumes, suggest that agricultural COPD is a predominantly non-emphysematous or essentially bronchial disease with IgE-mediated allergic mechanisms.

The current project BALISTIC 2 proposes to conduct a comparative study at + 6 years on average of the two groups of COPD subjects identified in BALISTIC 1 in order to specify the phenotype of COPD in dairy farmers by, in particular, the study of the rate of decline of resting and exercise respiratory function parameters, its computed tomography presentation and its genetic and epigenetic profile.

The prospects of this work are to improve the management of COPD in any cause by setting up preventive and curative therapeutic approaches in order to provide answers to the progression of a disease that makes part of the few major public health problems of the 21st century.

Condition or Disease Intervention/Treatment Phase
  • Other: Pulmonary Function Testing

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Characterization of Professional COPD Related to Exposure to Organic Dust - Mean Follow up at 6 Years
Actual Study Start Date :
Sep 20, 2018
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Dairy farmers COPD

Other: Pulmonary Function Testing
Pulmonary Function Testing, Cardiopulmonary exercise testing, 6 Minute walk test, Thoracic CT
Other Names:
  • Cardiopulmonary exercise testing
  • 6 Minute walk test
  • Thoracic CT

    		•
    Non farmers COPD

    Other: Pulmonary Function Testing
    Pulmonary Function Testing, Cardiopulmonary exercise testing, 6 Minute walk test, Thoracic CT
    Other Names:
  • Cardiopulmonary exercise testing
  • 6 Minute walk test
  • Thoracic CT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Annual change in FEV1 judged by two spirometry performed on average at 6-year intervals and expressed in ml per year. [two spirometry performed on average at 6-year]

      Annual change in FEV1 judged by two spirometry performed on average at 6-year intervals and expressed in ml per year.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    46 Years to 85 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Patients who participated to BALISTIC 1 and who had been diagnosed with COPD, belonging to either the "dairy farmers COPD" group or the "non farmers COPD" group.
    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Besançon Besançon France 25000

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Besancon

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Besancon
    ClinicalTrials.gov Identifier:
    NCT03468101
    Other Study ID Numbers:
    • R/2016/53
    First Posted:
    Mar 16, 2018
    Last Update Posted:
    Aug 3, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire de Besancon
    COPD
    Dairy farmers
    Exposure Occupational
    FEV1

    Study Results

    No Results Posted as of Aug 3, 2021