Chronic Obstructive Pulmonary Disease (COPD)BALISTICNCT02540408
Detection and Characterization of COPD in Dairy Farmers
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Environmental Exposure, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Environmental Exposure
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- subject aged 40-74 years
- either dairy farmer or unexposed to any occupational risk factor for COPD
Who cannot join
- COPD in GOLD stage 4
- pregnancy
- treatment with systemic corticosteroids
- established diagnosis of asthma
- established diagnosis of bronchiectasis
- established diagnosis of allergic alveolitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COPD in Dairy Farmers: Screening, Characterization and Constitution of a Cohort. The BALISTIC Study
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.
Read the detailed description
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.
- Keywords
- Occupational COPD, Pathophysiology, Exercise limitation, Pulmonary hyperinflation, Arterial stiffness
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| presence of COPD | COPD patients are defined according to the results of a spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of COPD in dairy farmers and in unexposed subjects
Measured: 3-year
Secondary outcomes (9)
comparison of smoking habits between dairy farmers with COPD and unexposed COPD
Measured: 4-year
comparison of dyspnoea between dairy farmers with COPD and unexposed COPD
, quality of life, lung function, bronchial exhaled nitric oxide, systemic inflammation, arterial stiffness and exercise capacity
Measured: 4-year
comparison of lung function between dairy farmers with COPD and unexposed COPD
Measured: 4-year
comparison of bronchial exhaled nitric oxide between dairy farmers with COPD and unexposed COPD
Measured: 4-year
comparison of systemic inflammation between dairy farmers with COPD and unexposed COPD
Measured: 4-year
comparison of arterial stiffness between dairy farmers with COPD and unexposed COPD
Measured: 4-year
comparison of exercise capacity between dairy farmers with COPD and unexposed COPD
Measured: 4-year
comparison of exposure to organic dusts between dairy farmers with and without COPD
Measured: 3-year
comparison of immunization to organic dusts between dairy farmers with and without COPD
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startNov 2011
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Degano, MD, PhD, Principal investigator, CHU BesançonJean-Charles Dalphin, MD, PhD, Study chair, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540408
- Sponsor's protocol ID
- P-2011-119
- Acronym
- BALISTIC
- Status last verified
- Sep 2015
- First submitted
- 29 Aug 2013
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23200591Veil-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.
PubMed 31208466
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPD in Dairy Farmers: Screening, Characterization and Constitution of a Cohort. The BALISTIC Study
- ClinicalTrials.gov ID
- NCT02540408
- Acronym / sponsor ID
- BALISTIC / P-2011-119
- Keywords
- Occupational COPD, Pathophysiology, Exercise limitation, Pulmonary hyperinflation, Arterial stiffness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| presence of COPD | – | –COPD patients are defined according to the results of a spirometry |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- subject aged 40-74 years
- either dairy farmer or unexposed to any occupational risk factor for COPD
Key exclusion criteria (6 listed)
- COPD in GOLD stage 4
- pregnancy
- treatment with systemic corticosteroids
- established diagnosis of asthma
- established diagnosis of bronchiectasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of COPD in dairy farmers and in unexposed subjects
Time frame: 3-year
9 secondary outcomes
comparison of smoking habits between dairy farmers with COPD and unexposed COPD
Time frame: 4-year
comparison of dyspnoea between dairy farmers with COPD and unexposed COPD
Time frame: 4-year
comparison of lung function between dairy farmers with COPD and unexposed COPD
Time frame: 4-year
comparison of bronchial exhaled nitric oxide between dairy farmers with COPD and unexposed COPD
Time frame: 4-year
comparison of systemic inflammation between dairy farmers with COPD and unexposed COPD
Time frame: 4-year
comparison of arterial stiffness between dairy farmers with COPD and unexposed COPD
Time frame: 4-year
comparison of exercise capacity between dairy farmers with COPD and unexposed COPD
Time frame: 4-year
comparison of exposure to organic dusts between dairy farmers with and without COPD
Time frame: 3-year
comparison of immunization to organic dusts between dairy farmers with and without COPD
Time frame: 3-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Background: PubMed 23200591Degano 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.
- Derived from this study: PubMed 31208466Veil-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Degano, MD, PhD principal investigator
CHU Besançon
Jean-Charles Dalphin, MD, PhD study chair
CHU Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Environmental Exposure, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of COPD in dairy farmers and in unexposed subjects (time frame: 3-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02540408, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.