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

COPD Clinical Trial

— BALISTIC 2  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03468101
• Other study ID #: R/2016/53
• Status: Terminated
• Start date: September 20, 2018
• Est. completion date: September 20, 2020

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: September 20, 2020
• Est. primary completion date: September 20, 2020
• Gender: All
• Age group: 46 Years to 85 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• COPD
• Exposure Occupational

Intervention

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

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annual change in FEV1 judged by two spirometry performed on average at 6-year intervals and expressed in ml per year.	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