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Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC) (ICONIC)

Primary Purpose

Smokers, Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exhaustive exploration
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Smokers focused on measuring Incident Chronic Obstructive Pulmonary Disease, comorbidities, trajectories

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Inclusion criteria of smokers with spirometry (pre-inclusion)

  • Age> 35 years
  • Smoking > 20 PA
  • Signature of consent to participate in Phase I of the study

Inclusion criteria for patients with incidental COPD

  • FEV1 / FVC <70% of the theoretical value and / or <LLN (Lower limit of normal)
  • Signature of consent to participate in Phase II of the study

Exclusion Criteria:

  • Known COPD
  • Chronic inflammatory disease or cancer being treated
  • No affiliation to the social security or other social protection scheme
  • Pregnant or lactating woman
  • Patient deprived of liberty or under legal protection (under tutorship or curatorship

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Exhaustive exploration

    Arm Description

    Exhaustive exploration of newly diagnosed COPD patients (pulmonary pathology and associated comorbidities)

    Outcomes

    Primary Outcome Measures

    1-year adverse evolution
    1-year adverse evolution defined by a composite criterion associating: - Occurrence of an additional exacerbation defined by any event requiring the use of the care system (visit to the doctor, emergencies, or hospitalization, for respiratory aggravation) with prescription of antibiotics or systemic steroids AND/OR - Increased dyspnea by 1 point on the MMRC dyspnea score AND/OR - CAT> 10 or 2 points increase on CAT symptom scores

    Secondary Outcome Measures

    Adverse evolution
    - Occurrence of an additional exacerbation defined by any event requiring the use of the care system (visit to the doctor, emergencies, or hospitalization, for respiratory aggravation) with prescription of antibiotics or systemic steroids AND/OR - Increased dyspnea by 1 point on the MMRC dyspnea score AND/OR - CAT> 10 or 2 points increase on CAT symptom scores
    Exacerbation
    Occurrence of an additional exacerbation defined by any event requiring the use of the care system (visit to the doctor, emergencies, or hospitalization, for respiratory aggravation) with prescription of antibiotics or systemic steroids
    Number of steps
    Number of steps in the month preceding the visit evaluated by a pedometer
    Forced Expiratory Volume in one second (FEV1)
    Forced Expiratory Volume in one second (FEV1)
    Hospital Anxiety and Depression scale
    Anxious symptoms or depressions
    FEV 1 / Respiratory function parameters
    Respiratory function parameters with FEV 1
    DLCO / Respiratory function parameters
    Respiratory function parameters with DLCO
    Residual volume / Respiratory function parameters
    Respiratory function parameters with residual volume
    Total lung capacity / Respiratory function parameters
    Respiratory function parameters with total lung capacity
    Arterial stiffness
    Arterial stiffness measured by the pulse wave velocity (Complior)
    LVEF / Echocardiography
    LVEF measured by echocardiography
    Diastolic dysfunction / Echocardiography
    diastolic dysfunction measured by echocardiography
    PAPS / Echocardiography
    PAPS measured by echocardiography
    Skeletal muscle index
    Skeletal muscle index evaluated by IDEXA
    Muscle function
    Muscle strength by grip and pinch
    Hospital Anxiety and Depression scale
    Measurement of anxiety symptoms or depression via the Hospital Anxiety and Depression scale.
    Numbers of deaths
    Numbers of deaths

    Full Information

    First Posted
    January 6, 2020
    Last Updated
    January 31, 2020
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04252781
    Brief Title
    Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)
    Acronym
    ICONIC
    Official Title
    Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2020 (Anticipated)
    Primary Completion Date
    February 2023 (Anticipated)
    Study Completion Date
    February 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Chronic Obstructive Pulmonary Disease (COPD), , secondary to smoking, is a major public health issue with very high direct and indirect costs. The impact on the health system of undiagnosed patients, up to 70% of patients, is increasingly documented. However, systematic spirometry screening remains controversial among smokers in the absence of data to link the detection of new patients with improved management and clinical events and health goals. More generally, there is little data on the evolution of patients in real life once they have entered the care system. The premise is that with systematic screening in general medicine, it is possible to identify the evolution of newly diagnosed COPD patients, to distinguish the different possible evolutions according to the initial phenotype and the management.
    Detailed Description
    A description of the population from which the groups or cohorts will be selected Smokers who have a screening spirometry for COPD, either in general medicine, at a pulmonologist or in the CHIC or Henri Mondor hospital respiratory function tests department. After screening, an equal number of men and women COPD will be included (150 men and 150 women). 1500 smokers will be included to reach 300 smokers with COPD.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Smokers, Chronic Obstructive Pulmonary Disease
    Keywords
    Incident Chronic Obstructive Pulmonary Disease, comorbidities, trajectories

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Exhaustive exploration
    Arm Type
    Other
    Arm Description
    Exhaustive exploration of newly diagnosed COPD patients (pulmonary pathology and associated comorbidities)
    Intervention Type
    Other
    Intervention Name(s)
    Exhaustive exploration
    Intervention Description
    clinical investigations imagery blood assessment functional respiratory investigations muscle function / skeletal muscle index
    Primary Outcome Measure Information:
    Title
    1-year adverse evolution
    Description
    1-year adverse evolution defined by a composite criterion associating: - Occurrence of an additional exacerbation defined by any event requiring the use of the care system (visit to the doctor, emergencies, or hospitalization, for respiratory aggravation) with prescription of antibiotics or systemic steroids AND/OR - Increased dyspnea by 1 point on the MMRC dyspnea score AND/OR - CAT> 10 or 2 points increase on CAT symptom scores
    Time Frame
    at 12 Months
    Secondary Outcome Measure Information:
    Title
    Adverse evolution
    Description
    - Occurrence of an additional exacerbation defined by any event requiring the use of the care system (visit to the doctor, emergencies, or hospitalization, for respiratory aggravation) with prescription of antibiotics or systemic steroids AND/OR - Increased dyspnea by 1 point on the MMRC dyspnea score AND/OR - CAT> 10 or 2 points increase on CAT symptom scores
    Time Frame
    at 3 Months and 6 Months
    Title
    Exacerbation
    Description
    Occurrence of an additional exacerbation defined by any event requiring the use of the care system (visit to the doctor, emergencies, or hospitalization, for respiratory aggravation) with prescription of antibiotics or systemic steroids
    Time Frame
    at 3 Months, 6 Months and 12 Months
    Title
    Number of steps
    Description
    Number of steps in the month preceding the visit evaluated by a pedometer
    Time Frame
    at 3 Months, 6 Months and 12 Months
    Title
    Forced Expiratory Volume in one second (FEV1)
    Description
    Forced Expiratory Volume in one second (FEV1)
    Time Frame
    at 3 Months, 6 Months and 12 Months
    Title
    Hospital Anxiety and Depression scale
    Description
    Anxious symptoms or depressions
    Time Frame
    at 3 Months, 6 Months and 12 Months
    Title
    FEV 1 / Respiratory function parameters
    Description
    Respiratory function parameters with FEV 1
    Time Frame
    at 12 Months
    Title
    DLCO / Respiratory function parameters
    Description
    Respiratory function parameters with DLCO
    Time Frame
    at 12 Months
    Title
    Residual volume / Respiratory function parameters
    Description
    Respiratory function parameters with residual volume
    Time Frame
    at 12 Months
    Title
    Total lung capacity / Respiratory function parameters
    Description
    Respiratory function parameters with total lung capacity
    Time Frame
    at 12 Months
    Title
    Arterial stiffness
    Description
    Arterial stiffness measured by the pulse wave velocity (Complior)
    Time Frame
    at 12 Months
    Title
    LVEF / Echocardiography
    Description
    LVEF measured by echocardiography
    Time Frame
    at 12 Months
    Title
    Diastolic dysfunction / Echocardiography
    Description
    diastolic dysfunction measured by echocardiography
    Time Frame
    at 12 Months
    Title
    PAPS / Echocardiography
    Description
    PAPS measured by echocardiography
    Time Frame
    at 12 Months
    Title
    Skeletal muscle index
    Description
    Skeletal muscle index evaluated by IDEXA
    Time Frame
    at 12 Months
    Title
    Muscle function
    Description
    Muscle strength by grip and pinch
    Time Frame
    at 12 Months
    Title
    Hospital Anxiety and Depression scale
    Description
    Measurement of anxiety symptoms or depression via the Hospital Anxiety and Depression scale.
    Time Frame
    at 12 Months
    Title
    Numbers of deaths
    Description
    Numbers of deaths
    Time Frame
    at 12 Months

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    After screening, an equal number of men and women COPD will be included (150 men and 150 women).
    Minimum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Inclusion criteria of smokers with spirometry (pre-inclusion) Age> 35 years Smoking > 20 PA Signature of consent to participate in Phase I of the study Inclusion criteria for patients with incidental COPD FEV1 / FVC <70% of the theoretical value and / or <LLN (Lower limit of normal) Signature of consent to participate in Phase II of the study Exclusion Criteria: Known COPD Chronic inflammatory disease or cancer being treated No affiliation to the social security or other social protection scheme Pregnant or lactating woman Patient deprived of liberty or under legal protection (under tutorship or curatorship
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Laurent BOYER, MD
    Phone
    (0) 1 49 81 26 90
    Ext
    + 33
    Email
    laurent.boyer@aphp.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    David SCHMITZ
    Phone
    (0) 1 49 81 36 24
    Ext
    +33
    Email
    david.schmitz@aphp.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Laurent BOYER, MD
    Organizational Affiliation
    Assistance Publique Hôpitaux de Paris (AP-HP)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)

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