COPD MSA 3 Regions: Epidemiology and Risk Factors of COPD in Rural Environment (BM3R)

NCT03299907 | Completed

• 1 other identifier: P/2013/161
• Study Type: observational
• Target: 5,263
• Locations: 0 countries
• Sites: N/A

Brief Summary

The agricultural environment presents a unique profile in terms of epidemiology of pulmonary diseases. Certainly due to persistent exposure to organic particles, the prevalence of COPD is higher in farmers than in the general population, despite less smoking. It is likely that the risk of COPD depends on several factors, such as the type of farm, local conditions and the region where the farm is located. It is important to diagnose COPD at an early stage in order to initiate appropriate therapy, and implement secondary prevention with a view to limiting deterioration of respiratory function and reducing complications. In this context, the aims of BM3R project were: (1) to study the epidemiology of COPD in a large representative sample of French farmers, in order to identify the types of farming, working conditions and regions that are associated with the presence of COPD; and (2) to develop a score to identify patients at risk and optimise diagnosis of COPD in the context of a screening programme.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• FEV1/FVC

  At the inclusion time

Study Arms (2)

COPD

Subject with FEV1/FVC post BD \< 0.7 or LLN

Diagnostic Test: Spirometry

Non COPD

Subject with FEV1/FVC post BD \>= 0.7 or LLN

Diagnostic Test: Spirometry

Interventions

Spirometry DIAGNOSTIC_TEST

COPD; Non COPD

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data were collected between October 2012 and May 2013 in two French regions (Brittany and Franche-Comté) among affiliated members (farmers and administrative workers of both sexes) of the MSA.

You may qualify if:

• \> 40 years old and \< 75 years old
• Affiliated to the MSA

You may not qualify if:

• COPD known

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Mutualité sociale agricole: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Spirometry

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)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Bruno DEGANO, MD

  CHU Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 3, 2017
• Study Start: November 1, 2012
• Primary Completion: May 30, 2013
• Study Completion: May 30, 2014
• Last Updated: October 3, 2017

Record last verified: 2017-09