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

NCT03468101 — Terminated, 90 participants, Centre Hospitalier Universitaire de Besancon

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Registry	NCT03468101, acronym BALISTIC 2
Status	Terminated - COVID-19
Study type	Observational
Enrollment	90 (Actual)
Sponsor	Centre Hospitalier Universitaire de Besancon (Other)
Conditions	COPD, Exposure Occupational
Interventions	Pulmonary Function Testing (Other)
Dates	start 2018-09-20, primary completion 2020-09-20, completion 2020-09-20, first posted 2018-03-16, last updated 2024-02-23
Locations	1 site in France

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Dairy farmers COPD		Other: Pulmonary Function Testing
Non farmers COPD		Other: Pulmonary Function Testing

Pulmonary Function Testing (Other), also known as Cardiopulmonary exercise testing, 6 Minute walk test, Thoracic CT: Pulmonary Function Testing, Cardiopulmonary exercise testing, 6 Minute walk test, Thoracic CT

+Outcome measures

Primary outcomes

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

Sex: All, ages: 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:

\-

+Locations (1)

Facility	City	Country	Status
CHU de Besançon	Besançon	France

My Notes

Public

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