Bronchial Obstruction in Dairy Farmers

Completed

• Conditions: COPD

• Registration Number: NCT03654469
• Lead Sponsor: Rennes University Hospital

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a major public health problem and is expected to become the 3rd leading cause of death globally by 2020.

The main risk factor is tobacco. Tobacco poisoning is found in 80 to 90% of patients with COPD. However, non-smoking COPD is also described, with increasing prevalence figures, particularly related to occupational exposure, especially among farmers.

Detailed Description

A prospective screening study based on questionnaires and electronic mini-spirometry (Néo-6®) that includes a representative sample of dairy farmers from the departments of Morbihan and Île-et-Vilaine in Brittany.

The dairy farmers had an occupational medicine appointment and, if they demonstrated at least one marker of possible bronchial obstruction (chronic cough, chronic bronchitis, dyspnoea, wheezing, spirometry), they were referred to a pulmonologist.

Study Timeline

• Study Start: 2012-02-27
• Study First Submitted: 2016-09-13
• Primary Completion: 2017-02-15
• Study First Submitted QC: 2018-08-28
• Study First Posted: 2018-08-31
• Study Completion: 2019-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1247

Inclusion Criteria

• dairy farmers from the departments of Morbihan and Île-et-Vilaine in Brittany
• control: non farmer

Exclusion Criteria

• pigs or grain farmers
• Pregnant women
• oral corticosteroids or immunosuppressive drugs

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Level of bronchial obstruction	3 years	Respiratory specific indices are extracted from a screening spirometry : Forced expiratory volume in one second (FEV1) Forced Vital Capacity (FVC); Bronchial obstruction is stated with a ratio FEV1 / FVC \< 0.8

Secondary Outcome Measures

Name	Time	Method
Prevalence of occupational specific COPD in dairy farmers	3 years	Occupational specific COPD is defined as a ratio FEV1 / FVC \< 0.8 associated to a clinical situation : * non reversibility after β2-agonists or corticoids administration,; * no personal nor familial allergic conditions,; * smoking history \< 1 cigarettes package per year.

Trial Locations

Locations (1)

Rennes University Hospital - Service de Pneumologie; 🇫🇷 Rennes, France