Chronic Obstructive Pulmonary DiseaseBPCONCT02888886
Role of Systemic Inflammation in Increase of Cardio-vascular Risk in Chronic Obstructive Pulmonary Disease
A study testing Questionnaires about food habits and tobacco, Spirometry and Carotid echography in people with Chronic Obstructive Pulmonary Disease, run by Central Hospital, Nancy, France.
Trial summary
The purpose is to study the correlation between systemic inflammation (serum levels of CRP, IL-1beta, IL-6 and TNF-alpha) or hyperhomocysteinemia and the increase of mortality, in a representative cohort of patients with chronic obstructive pulmonary disease (COPD). Secondary purposes are: 1. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Questionnaires about food habits and tobacco, Spirometry and Carotid echography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Nov 2015
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Actual or past active smoking of at least 20 packets/year
- FEV1/FVC < 70%
Who cannot join
- Co-morbidity except essential arterial hypertension controlled by treatment, stable coronary disease, type 2 diabetes and/or degenerative arthropathy (non-inflammatory rheumatic disorder)
- Acute disorder during 8 weeks before inclusion, especially COPD worsening
- Long-term corticosteroid or non-steroid anti-inflammatory treatment
About this study
The purpose is to study the correlation between systemic inflammation (serum levels of CRP, IL-1beta, IL-6 and TNF-alpha) or hyperhomocysteinemia and the increase of mortality, in a representative cohort of patients with chronic obstructive pulmonary disease (COPD).
Secondary purposes are:
- To confirm the increase of cardiovascular mortality and the importance of cardiovascular morbidity in patients with COPD,
- To establish the role of various genetic polymorphisms in the correlation between systemic inflammation and cardiovascular disorders observed in COPD,
- To search for acceleration of aging of cardiovascular system evaluated with carotid intima-media thickness when systemic inflammation markers are increased,
- To study the correlation between COPD risk factors (tobacco and other food factors), change of respiratory functional data and cardiovascular morbi-mortality. In this study cardiovascular morbi-mortality is defined by following disorders: ischemic cardiopathy, left-sided heart failure, cardiac arrhythmia and cerebrovascular accident. Diagnosis is confirmed with standard techniques and independently of this study. Results of clinical examination, ECG, echocardiography and /or brain scanner will be collected.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Questionnaires about food habits and tobacco, Spirometry, Carotid echography, Blood sample
- Keywords
- systemic inflammation
- 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 about food habits and tobaccoOther
SpirometryOther
Carotid echographyOther
Blood sampleOther
for genetic polymorphism analysis, CRP, homocysteine and cytokine tests, glycemia and dyslipidemia analyses
| Study group | Role | What they receive |
|---|---|---|
| COPD | Experimental | Not described Receives: Other: Questionnaires about food habits and tobacco; Other: Spirometry; Other: Carotid echography; Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startJul 2007
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ari CHAOUAT, Pr, Principal investigator, Service des Maladies Respiratoires et Réanimation Respiratoire- Hôpital de Brabois- CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888886
- Sponsor's protocol ID
- 2006-A00053-48
- Acronym
- BPCO
- Status last verified
- Aug 2016
- First submitted
- 31 Aug 2016
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Systemic Inflammation in Increase of Cardio-vascular Risk in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02888886
- Acronym / sponsor ID
- BPCO / 2006-A00053-48
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- systemic inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 5 Sep 2016 (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.
The purpose is to study the correlation between systemic inflammation (serum levels of CRP, IL-1beta, IL-6 and TNF-alpha) or hyperhomocysteinemia and the increase of mortality, in a representative cohort of patients with chronic obstructive pulmonary disease (COPD).
Secondary purposes are:
- To confirm the increase of cardiovascular mortality and the importance of cardiovascular morbidity in patients with COPD,
- To establish the role of various genetic polymorphisms in the correlation between systemic inflammation and cardiovascular disorders observed in COPD,
- To search for acceleration of aging of cardiovascular system evaluated with carotid intima-media thickness when systemic inflammation markers are increased,
- To study the correlation between COPD risk factors (tobacco and other food factors), change of respiratory functional data and cardiovascular morbi-mortality. In this study cardiovascular morbi-mortality is defined by following disorders: ischemic cardiopathy, left-sided heart failure, cardiac arrhythmia and cerebrovascular accident. Diagnosis is confirmed with standard techniques and independently of this study. Results of clinical examination, ECG, echocardiography and /or brain scanner will be collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD | Experimental | Other: Questionnaires about food habits and tobacco, Other: Spirometry, Other: Carotid echography, Other: Blood sample |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Actual or past active smoking of at least 20 packets/year
- FEV1/FVC < 70%
Key exclusion criteria (3 listed)
- Co-morbidity except essential arterial hypertension controlled by treatment, stable coronary disease, type 2 diabetes and/or degenerative arthropathy (non-inflammatory rheumatic disorder)
- Acute disorder during 8 weeks before inclusion, especially COPD worsening
- Long-term corticosteroid or non-steroid anti-inflammatory treatment
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 about food habits and tobacco | Other | COPD |
| Spirometry | Other | COPD |
| Carotid echography | Other | COPD |
| Blood samplefor genetic polymorphism analysis, CRP, homocysteine and cytokine tests, glycemia and dyslipidemia analyses | Other | COPD |
Primary outcome
Mortality
Time frame: 5 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 5 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Ari CHAOUAT, Pr principal investigator
Service des Maladies Respiratoires et Réanimation Respiratoire- Hôpital de Brabois- CHRU de Nancy
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires about food habits and tobacco, Spirometry and Carotid echography in people with Chronic Obstructive Pulmonary Disease, run by Central Hospital, Nancy, 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 5 Sep 2016. 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?
Mortality (time frame: 5 years). 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 5 Sep 2016; AzTrials last refreshed its copy on 8 Nov 2026.