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

NCT03468101 | Terminated DMC

• 1 other identifier: R/2016/53
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Exposure Occupational

Keywords

COPD; Dairy farmers; Exposure Occupational; FEV1

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Dairy farmers COPD

Other: Pulmonary Function Testing

Non farmers COPD

Other: Pulmonary Function Testing

Interventions

Pulmonary Function Testing OTHER

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

Also known as: Cardiopulmonary exercise testing, 6 Minute walk test, Thoracic CT

Dairy farmers COPD; Non farmers COPD

Eligibility Criteria

• Age: 46 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Respiratory Physiological Phenomena; Exercise Test

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 16, 2018
• Study Start: September 20, 2018
• Primary Completion: September 20, 2020
• Study Completion: September 20, 2020
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)