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Role of Systemic Inflammation in Increase of Cardio-vascular Risk in Chronic Obstructive Pulmonary Disease (BPCO)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Questionnaires about food habits and tobacco
Spirometry
Carotid echography
Blood sample
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease focused on measuring systemic inflammation

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Actual or past active smoking of at least 20 packets/year
  • FEV1/FVC < 70%

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    COPD

    Arm Description

    Outcomes

    Primary Outcome Measures

    Mortality

    Secondary Outcome Measures

    Full Information

    First Posted
    August 31, 2016
    Last Updated
    August 31, 2016
    Sponsor
    Central Hospital, Nancy, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02888886
    Brief Title
    Role of Systemic Inflammation in Increase of Cardio-vascular Risk in Chronic Obstructive Pulmonary Disease
    Acronym
    BPCO
    Official Title
    Role of Systemic Inflammation in Increase of Cardio-vascular Risk in Chronic Obstructive Pulmonary Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2007 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Central Hospital, Nancy, France

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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: 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease
    Keywords
    systemic inflammation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    89 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    COPD
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Questionnaires about food habits and tobacco
    Intervention Type
    Other
    Intervention Name(s)
    Spirometry
    Intervention Type
    Other
    Intervention Name(s)
    Carotid echography
    Intervention Type
    Other
    Intervention Name(s)
    Blood sample
    Intervention Description
    for genetic polymorphism analysis, CRP, homocysteine and cytokine tests, glycemia and dyslipidemia analyses
    Primary Outcome Measure Information:
    Title
    Mortality
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Actual or past active smoking of at least 20 packets/year FEV1/FVC < 70% Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ari CHAOUAT, Pr
    Organizational Affiliation
    Service des Maladies Respiratoires et Réanimation Respiratoire- Hôpital de Brabois- CHRU de Nancy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Role of Systemic Inflammation in Increase of Cardio-vascular Risk in Chronic Obstructive Pulmonary Disease

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