Detection and Characterization of COPD in Dairy Farmers

NCT02540408 | Completed DMC

• 1 other identifier: P-2011-119
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

A pilot study from the investigators group suggests that the prevalence of chronic obstructive pulmonary disease (COPD) among dairy farmers is higher than in the general population. Most characteristics of COPD in dairy farmers (smoking habits, dyspnoea, quality of life, lung function, bronchial exhaled nitric oxide, systemic inflammation, arterial stiffness and exercise capacity) are largely unknown. Although immunization against organic dusts is suspected, the pathophysiology of COPD in dairy farmers is also unknown. This study therefore aims at (i) comparing the prevalence of COPD in dairy farmers and in subjects without any occupational exposure (control arm) through a vast COPD detection program in the Franche-Comté region; (ii) comparing several characteristics (smoking habits, dyspnoea, quality of life, lung function, bronchial exhaled nitric oxide, systemic inflammation, arterial stiffness and exercise capacity) between dairy farmers with COPD and patients with COPD without any occupational exposure; (iv) identifying etiological factors of COPD in dairy farmers (comparison of exposure and specific immunoglobulin E between dairy farmers with COPD and dairy farmers with normal pulmonary function tests); and (v) constituting a cohort of COPD patients and control subjects for further longitudinal studies. Data from selected patients (either current or former smokers) with mild COPD and from matched controls will also be analyzed in an ancillary study which objectives are to compare exercise tolerance, ventilatory constraints on tidal volume expansion and dyspnoea between asymptomatic mild COPD subjects, symptomatic mild COPD and healthy controls.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Environmental Exposure

Keywords

Occupational COPD; Pathophysiology; Exercise limitation; Pulmonary hyperinflation; Arterial stiffness

Outcome Measures

Primary Outcomes (1)

• prevalence of COPD in dairy farmers and in unexposed subjects

  3-year

Secondary Outcomes (9)

• comparison of smoking habits between dairy farmers with COPD and unexposed COPD

  4-year

• comparison of dyspnoea between dairy farmers with COPD and unexposed COPD

  4-year

• comparison of lung function between dairy farmers with COPD and unexposed COPD

  4-year

• comparison of bronchial exhaled nitric oxide between dairy farmers with COPD and unexposed COPD

  4-year

• comparison of systemic inflammation between dairy farmers with COPD and unexposed COPD

  4-year

Other Outcomes (4)

• comparison of dyspnoea between asymptomatic mild COPD subjects, symptomatic mild COPD and healthy controls

  2-year

• comparison of exercise tolerance dyspnoea between asymptomatic mild COPD subjects, symptomatic mild COPD and healthy controls

  2-year

• comparison of ventilatory constraints on tidal volume expansion between asymptomatic mild COPD subjects, symptomatic mild COPD and healthy controls

  2-year

Study Arms (1)

presence of COPD

COPD patients are defined according to the results of a spirometry

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

COPD patients will be defined according to the GOLD criteria (post-bronchodilator FEV1/FVC ratio\<70%). Healthy subjects must have pre-bronchodilator FEV1/FVC ratio \>75% and pre-bronchodilator FEV1 \>95% of predicted value.

You may qualify if:

• subject aged 40-74 years
• either dairy farmer or unexposed to any occupational risk factor for COPD

You may not qualify if:

• COPD in GOLD stage 4
• pregnancy
• treatment with systemic corticosteroids
• established diagnosis of asthma
• established diagnosis of bronchiectasis
• established diagnosis of allergic alveolitis

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU Jean Minjoz

Besançon, 25030, France

Location

Related Publications (2)

• Degano B, Bouhaddi M, Laplante JJ, Botebol M, Annesi-Maesano I, Marescaux A, Roux P, Thaon I, Wolf JP, Regnard J, Dalphin JC. [COPD in dairy farmers: screening, characterization and constitution of a cohort. The BALISTIC study]. Rev Mal Respir. 2012 Nov;29(9):1149-56. doi: 10.1016/j.rmr.2012.08.007. Epub 2012 Oct 15. French.

  PMID: 23200591 BACKGROUND

• Veil-Picard M, Soumagne T, Vongthilath R, Annesi-Maesano I, Guillien A, Laurent L, Andujar P, Roche N, Jouneau S, Cypriani B, Laplante JJ, Degano B, Dalphin JC. Is atopy a risk indicator of chronic obstructive pulmonary disease in dairy farmers? Respir Res. 2019 Jun 17;20(1):124. doi: 10.1186/s12931-019-1082-2.

  PMID: 31208466 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum for further analyses

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Bruno Degano, MD, PhD

  CHU Besançon

  PRINCIPAL INVESTIGATOR

• Jean-Charles Dalphin, MD, PhD

  CHU Besançon

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: September 4, 2015
• Study Start: November 1, 2011
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 8, 2016

Record last verified: 2015-09

Locations

FR (1)