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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252781
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Smokers Chronic Obstructive Pulmonary Disease Other: Exhaustive exploration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Exhaustive exploration
Exhaustive exploration of newly diagnosed COPD patients (pulmonary pathology and associated comorbidities)
Other: Exhaustive exploration
  • clinical investigations
  • imagery
  • blood assessment
  • functional respiratory investigations
  • muscle function / skeletal muscle index




Primary Outcome Measures :
  1. 1-year adverse evolution [ Time Frame: at 12 Months ]

    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 :
  1. Adverse evolution [ Time Frame: at 3 Months and 6 Months ]

    - 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


  2. Exacerbation [ Time Frame: at 3 Months, 6 Months and 12 Months ]
    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

  3. Number of steps [ Time Frame: at 3 Months, 6 Months and 12 Months ]
    Number of steps in the month preceding the visit evaluated by a pedometer

  4. Forced Expiratory Volume in one second (FEV1) [ Time Frame: at 3 Months, 6 Months and 12 Months ]
    Forced Expiratory Volume in one second (FEV1)

  5. Hospital Anxiety and Depression scale [ Time Frame: at 3 Months, 6 Months and 12 Months ]
    Anxious symptoms or depressions

  6. FEV 1 / Respiratory function parameters [ Time Frame: at 12 Months ]
    Respiratory function parameters with FEV 1

  7. DLCO / Respiratory function parameters [ Time Frame: at 12 Months ]
    Respiratory function parameters with DLCO

  8. Residual volume / Respiratory function parameters [ Time Frame: at 12 Months ]
    Respiratory function parameters with residual volume

  9. Total lung capacity / Respiratory function parameters [ Time Frame: at 12 Months ]
    Respiratory function parameters with total lung capacity

  10. Arterial stiffness [ Time Frame: at 12 Months ]
    Arterial stiffness measured by the pulse wave velocity (Complior)

  11. LVEF / Echocardiography [ Time Frame: at 12 Months ]
    LVEF measured by echocardiography

  12. Diastolic dysfunction / Echocardiography [ Time Frame: at 12 Months ]
    diastolic dysfunction measured by echocardiography

  13. PAPS / Echocardiography [ Time Frame: at 12 Months ]
    PAPS measured by echocardiography

  14. Skeletal muscle index [ Time Frame: at 12 Months ]
    Skeletal muscle index evaluated by IDEXA

  15. Muscle function [ Time Frame: at 12 Months ]
    Muscle strength by grip and pinch

  16. Hospital Anxiety and Depression scale [ Time Frame: at 12 Months ]
    Measurement of anxiety symptoms or depression via the Hospital Anxiety and Depression scale.

  17. Numbers of deaths [ Time Frame: at 12 Months ]
    Numbers of deaths



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   After screening, an equal number of men and women COPD will be included (150 men and 150 women).
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252781


Contacts
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Contact: Laurent BOYER, MD (0) 1 49 81 26 90 ext + 33 laurent.boyer@aphp.fr
Contact: David SCHMITZ (0) 1 49 81 36 24 ext +33 david.schmitz@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Laurent BOYER, MD Assistance Publique Hôpitaux de Paris (AP-HP)
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04252781    
Other Study ID Numbers: K180305J
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Incident Chronic Obstructive Pulmonary Disease
comorbidities
trajectories
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases