NCT02540408|CompletedDMC
Detection and Characterization of COPD in Dairy Farmers
BALISTIC
COPD in Dairy Farmers: Screening, Characterization and Constitution of a Cohort. The BALISTIC Study
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BALISTIC
COPD in Dairy Farmers: Screening, Characterization and Constitution of a Cohort. The BALISTIC Study
Sponsor study identifier
observational
400
1 country
1
Study Start
November 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2015
Actual (reported)Study Completion
November 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2011
Date type not reportedThis date has not been verified as actual or estimated.
August 29, 2013
Actual (reported)September 4, 2015
Actual (reported)November 2015
Actual (reported)November 2015
Actual (reported)prevalence of COPD in dairy farmers and in unexposed subjects
3-year
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
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
COPD patients are defined according to the results of a spirometry
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.
CHU Jean Minjoz
Besançon, 25030, France
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.
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.
Serum for further analyses
Bruno Degano, MD, PhD
CHU Besançon
Jean-Charles Dalphin, MD, PhD
CHU Besançon
400 participants (actual enrollment reported by the registry).
First Submitted
August 29, 2013
First Posted
September 4, 2015
Study Start
November 2011
Date type not reportedThis date has not been verified as actual or estimated.
Antioxidants and Pulmonary Rehabilitation in COPD Patients
Contact the study team to confirm eligibility.
Primary Completion
November 2015
Actual (reported)Study Completion
November 2015
Actual (reported)Last Updated
February 8, 2016
Record last verified: 2015-09
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