Skip to main content
OpenTrials
Completed

NCT Number: NCT02540408

Detection and Characterization of COPD in Dairy Farmers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Environmental Exposure Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Jean Minjoz

Besançon, 25030, France

About this study

2000 dairy workers and 2000 subjects without any occupational exposure, all aged 40 to 74 years, will take part to a COPD screening program (spirometry and bronchodilation test) between September 2011 and October 2014.

Subjects with COPD and healthy matched controls will attend a second visit. If needed, COPD subjects will be asked to stop any respiratory related medication such as short and long acting bronchodilators 72 hours prior to the visit. All subjects will complete several questionnaires (quality of life, respiratory symptoms, smoking habits,…). A complete medical history will be collected, and a blood sample will be taken. Subjects thereafter will complete arterial stiffness measurement, exhaled nitric oxide and pulmonary function testing pre- and 30-min post-bronchodilator. A symptom-limited incremental cycle exercise test will be performed on the same day, at least 6 hours after the bronchodilator test and at least 4 hours after the meal.

Exposure to organic dusts will be quantified through analyze of electrostatic wipes left at subjects' homes for 10 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. prevalence of COPD in dairy farmers and in unexposed subjects

    Time frame: 3-year

Secondary outcomes

  1. comparison of smoking habits between dairy farmers with COPD and unexposed COPD

    Time frame: 4-year

  2. comparison of dyspnoea between dairy farmers with COPD and unexposed COPD

    Time frame: 4-year

    , quality of life, lung function, bronchial exhaled nitric oxide, systemic inflammation, arterial stiffness and exercise capacity

  3. comparison of lung function between dairy farmers with COPD and unexposed COPD

    Time frame: 4-year

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

    Time frame: 4-year

  5. comparison of systemic inflammation between dairy farmers with COPD and unexposed COPD

    Time frame: 4-year

  6. comparison of arterial stiffness between dairy farmers with COPD and unexposed COPD

    Time frame: 4-year

  7. comparison of exercise capacity between dairy farmers with COPD and unexposed COPD

    Time frame: 4-year

  8. comparison of exposure to organic dusts between dairy farmers with and without COPD

    Time frame: 3-year

  9. comparison of immunization to organic dusts between dairy farmers with and without COPD

    Time frame: 3-year

Other outcomes

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

    Time frame: 2-year

    the magnitude of their perceived breathing discomfort at rest, at the middle of warm up, every 2-minute during exercise, and at peak exercise is rated by pointing to the 10-point Borg scale

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

    Time frame: 2-year

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

    Time frame: 2-year

    In the relationship between tidal volume (VT) and ventilation (V'E), there is an inflection point beyond which almost no further change in VT is possible despite a continued increase in V'E. This inflection in the VT response marks the point were dyspnoea sharply raises because of mechanical constraints on VT expansion. This inflection point is determined for each patient by analyzing individual Hey plot.

  4. cardiovascular risk in COPD patients either never-smokers or current/former smokers

    Time frame: 3-year

    comparison of pulse wave velocity between smoking and non-smoking COPD

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

COPD in Dairy Farmers: Screening, Characterization and Constitution of a Cohort. The BALISTIC Study

Acronym: BALISTIC

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Sep 4, 2015
Registry last updated
Feb 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.