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NCT Number: NCT04252781

Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)

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.

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Key information

Conditions

Smokers Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Henri MONDOR

Créteil, Île-de-France Region, 94000, France

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

of smokers with spirometry (pre-inclusion)

  • Age> 35 years
  • Smoking > 20 PA
  • Active smoking (cessation < 1 month)
  • 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
  • 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

Treatment and study plan

Exhaustive exploration

Other
  • clinical investigations
  • imagery
  • blood assessment
  • functional respiratory investigations
  • muscle function / skeletal muscle index

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Laurent BOYER, MD

CONTACT

[email protected]

(0) 1 49 81 26 90 ext. + 33

Lila KACI

CONTACT

[email protected]

(0) 1 49 81 36 24 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: ICONIC

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Feb 5, 2020
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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