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

Terminated

• Conditions: Exposure Occupational; COPD
• Interventions: Other: Pulmonary Function Testing

• Registration Number: NCT03468101
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-16
• Study Start: 2018-09-20
• Primary Completion: 2020-09-20
• Study Completion: 2020-09-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non farmers COPD	Pulmonary Function Testing	-
Dairy farmers COPD	Pulmonary Function Testing	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

CHU de Besançon; 🇫🇷 Besançon, France