Pulmonary Disease, Chronic ObstructiveBM3RNCT03299907
COPD MSA 3 Regions: Epidemiology and Risk Factors of COPD in Rural Environment (BM3R)
An observational study of Pulmonary Disease, Chronic Obstructive, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
The agricultural environment presents a unique profile in terms of epidemiology of pulmonary diseases. Certainly due to persistent exposure to organic particles, the prevalence of COPD is higher in farmers than in the general population, despite less smoking. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Spirometry
- How many people
- 5,263 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2012to 30 May 2014
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Data were collected between October 2012 and May 2013 in two French regions (Brittany and Franche-Comté) among affiliated members (farmers and administrative workers of both sexes) of the MSA.
Who may be able to join
- > 40 years old and < 75 years old
- Affiliated to the MSA
Who cannot join
- COPD known
About this study
Official title: COPD MSA 3 Regions: Epidemiology and Risk Factors of COPD in Rural Environment (BPCO MSA 3Régions : épidémiologie et Facteurs de Risque de la BPCO en Milieu Rural)
The agricultural environment presents a unique profile in terms of epidemiology of pulmonary diseases. Certainly due to persistent exposure to organic particles, the prevalence of COPD is higher in farmers than in the general population, despite less smoking. It is likely that the risk of COPD depends on several factors, such as the type of farm, local conditions and the region where the farm is located. It is important to diagnose COPD at an early stage in order to initiate appropriate therapy, and implement secondary prevention with a view to limiting deterioration of respiratory function and reducing complications. In this context, the aims of BM3R project were: (1) to study the epidemiology of COPD in a large representative sample of French farmers, in order to identify the types of farming, working conditions and regions that are associated with the presence of COPD; and (2) to develop a score to identify patients at risk and optimise diagnosis of COPD in the context of a screening programme.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- 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.
SpirometryDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| COPD | Subject with FEV1/FVC post BD < 0.7 or LLN Receives: Diagnostic Test: Spirometry | |
| Non COPD | Subject with FEV1/FVC post BD >= 0.7 or LLN Receives: Diagnostic Test: Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1/FVC
Measured: At the inclusion time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start1 Nov 2012
- Primary completion30 May 2013
- Study completion30 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 5,263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Mutualité sociale agricole
- Responsible party
- Sponsor
- Investigators
- Bruno DEGANO, MD, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299907
- Sponsor's protocol ID
- P/2013/161
- Acronym
- BM3R
- Status last verified
- Sep 2017
- First submitted
- 28 Sep 2017
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPD MSA 3 Regions: Epidemiology and Risk Factors of COPD in Rural Environment (BPCO MSA 3Régions : épidémiologie et Facteurs de Risque de la BPCO en Milieu Rural)
- ClinicalTrials.gov ID
- NCT03299907
- Acronym / sponsor ID
- BM3R / P/2013/161
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,263 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Mutualité sociale agricole
- Study start
- 1 Nov 2012 (actual)
- Primary completion
- 30 May 2013 (actual)
- Study completion
- 30 May 2014 (actual)
- First posted
- 3 Oct 2017 (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.
The agricultural environment presents a unique profile in terms of epidemiology of pulmonary diseases. Certainly due to persistent exposure to organic particles, the prevalence of COPD is higher in farmers than in the general population, despite less smoking. It is likely that the risk of COPD depends on several factors, such as the type of farm, local conditions and the region where the farm is located. It is important to diagnose COPD at an early stage in order to initiate appropriate therapy, and implement secondary prevention with a view to limiting deterioration of respiratory function and reducing complications. In this context, the aims of BM3R project were: (1) to study the epidemiology of COPD in a large representative sample of French farmers, in order to identify the types of farming, working conditions and regions that are associated with the presence of COPD; and (2) to develop a score to identify patients at risk and optimise diagnosis of COPD in the context of a screening programme.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD | – | Diagnostic Test: SpirometrySubject with FEV1/FVC post BD < 0.7 or LLN |
| Non COPD | – | Diagnostic Test: SpirometrySubject with FEV1/FVC post BD >= 0.7 or LLN |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Data were collected between October 2012 and May 2013 in two French regions (Brittany and Franche-Comté) among affiliated members (farmers and administrative workers of both sexes) of the MSA.
Key inclusion criteria (2 listed)
- > 40 years old and < 75 years old
- Affiliated to the MSA
Key exclusion criteria (1 listed)
- COPD known
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 |
|---|---|---|
| Spirometry | Diagnostic test | COPD, Non COPD |
Primary outcome
FEV1/FVC
Time frame: At the inclusion time
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 3 Oct 2017.
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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 principal investigator
CHU Besançon
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by Centre Hospitalier Universitaire de Besancon.
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 1 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 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
FEV1/FVC (time frame: At the inclusion time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2017.