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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03468101
Acronym
BALISTIC 2
Enrollment
90
Registered
2018-03-16
Start date
2018-09-20
Completion date
2020-09-20
Last updated
2024-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Exposure Occupational

Keywords

COPD, Dairy farmers, Exposure Occupational, FEV1

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.

Interventions

Pulmonary Function Testing, Cardiopulmonary exercise testing, 6 Minute walk test, Thoracic CT

Sponsors

Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
46 Years to 85 Years

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

\-

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026