Characterization of Professional COPD Related to Exposure to Organic Dust - Mean Follow up at 6 Years (BALISTIC 2)

February 22, 2024 updated by: Centre Hospitalier Universitaire de Besancon

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25000
        • CHU de Besancon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dairy farmers COPD
Other: Pulmonary Function Testing
Pulmonary Function Testing, Cardiopulmonary exercise testing, 6 Minute walk test, Thoracic CT
Other Names:
  • Cardiopulmonary exercise testing
  • 6 Minute walk test
  • Thoracic CT
Non farmers COPD
Other: Pulmonary Function Testing
Pulmonary Function Testing, Cardiopulmonary exercise testing, 6 Minute walk test, Thoracic CT
Other Names:
  • Cardiopulmonary exercise testing
  • 6 Minute walk test
  • Thoracic CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annual change in FEV1 judged by two spirometry performed on average at 6-year intervals and expressed in ml per year.
Time Frame: 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.
two spirometry performed on average at 6-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2018

Primary Completion (Actual)

September 20, 2020

Study Completion (Actual)

September 20, 2020

Study Registration Dates

First Submitted

March 12, 2018

First Submitted That Met QC Criteria

March 12, 2018

First Posted (Actual)

March 16, 2018

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R/2016/53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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