COPDBPCO AirbagNCT03654469
Bronchial Obstruction in Dairy Farmers
An observational study of COPD, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- questionnaires and electronic mini-spirometry
- How many people
- 1,247 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2012to Dec 2019
- How long will I take part?
- 3 Years
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * dairy farmers from the departments of Morbihan and Île-et-Vilaine in Brittany * control: non farmer
Who may be able to join
- dairy farmers from the departments of Morbihan and Île-et-Vilaine in Brittany
- control: non farmer
Who cannot join
- pigs or grain farmers
- Pregnant women
- oral corticosteroids or immunosuppressive drugs
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- COPD
- Being tested
- questionnaires and electronic mini-spirometry
- 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.
questionnaires and electronic mini-spirometryOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of bronchial obstruction
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
Measured: 3 years
Secondary outcomes (1)
Prevalence of occupational specific COPD in dairy farmers
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start27 Feb 2012
- Primary completion15 Feb 2017
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,247 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Jouneau, MD, PhD, Study director, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654469
- Sponsor's protocol ID
- 35RC11_8953
- Other IDs
- 2011-A01010-41
- Acronym
- BPCO Airbag
- Status last verified
- Mar 2023
- First submitted
- 13 Sep 2016
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Jouneau S, Chapron A, Ropars C, Marette S, Robert AM, Gouyet T, Belleguic C, Rochefort-Morel C, Guillot S, Mailloux C, Desrues B, Viel JF; AIRBAg research group. Prevalence and risk factors of asthma in dairy farmers: Ancillary analysis of AIRBAg. Environ Res. 2022 Nov;214(Pt 4):114145. doi: 10.1016/j.envres.2022.114145. Epub 2022 Aug 20.
PubMed 35998695
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchial Obstruction in Dairy Farmers
- ClinicalTrials.gov ID
- NCT03654469
- Acronym / sponsor ID
- BPCO Airbag / 35RC11_8953
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,247 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 27 Feb 2012 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 31 Aug 2018 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * dairy farmers from the departments of Morbihan and Île-et-Vilaine in Brittany * control: non farmer
Key inclusion criteria (2 listed)
- dairy farmers from the departments of Morbihan and Île-et-Vilaine in Brittany
- control: non farmer
Key exclusion criteria (3 listed)
- pigs or grain farmers
- Pregnant women
- oral corticosteroids or immunosuppressive drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaires and electronic mini-spirometryprospective 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 | Other | – |
Primary outcome
Level of bronchial obstruction
Time frame: 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
1 secondary outcome
Prevalence of occupational specific COPD in dairy farmers
Time frame: 3 years
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 29 Mar 2023.
- Derived from this study: PubMed 35998695Jouneau S, Chapron A, Ropars C, Marette S, Robert AM, Gouyet T, Belleguic C, Rochefort-Morel C, Guillot S, Mailloux C, Desrues B, Viel JF; AIRBAg research group. Prevalence and risk factors of asthma in dairy farmers: Ancillary analysis of AIRBAg. Environ Res. 2022 Nov;214(Pt 4):114145. doi: 10.1016/j.envres.2022.114145. Epub 2022 Aug 20.
- Individual participant dataSharing planned: Undecided
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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.
Stéphane Jouneau, MD, PhD study director
Rennes University Hospital
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 COPD, run by Rennes University Hospital 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 3 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 29 Mar 2023. 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?
Level of bronchial obstruction (time frame: 3 years). 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 NCT03654469, which also lists 1 linked publication.
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 29 Mar 2023.