Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Smokers, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Exhaustive exploration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Exhaustive exploration<br>Exhaustive exploration of newly diagnosed COPD patients (pulmonary pathology and associated comorbidities) | Other: Exhaustive exploration<br>* clinical investigations imagery blood assessment functional respiratory investigations muscle function / skeletal muscle index<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at 3 Months and 6 Months | 
| 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 | at 3 Months, 6 Months and 12 Months | 
| Number of steps | Number of steps in the month preceding the visit evaluated by a pedometer | at 3 Months, 6 Months and 12 Months | 
| Forced Expiratory Volume in one second (FEV1) | Forced Expiratory Volume in one second (FEV1) | at 3 Months, 6 Months and 12 Months | 
| Hospital Anxiety and Depression scale | Anxious symptoms or depressions | at 3 Months, 6 Months and 12 Months | 
| FEV 1 / Respiratory function parameters | Respiratory function parameters with FEV 1 | at 12 Months | 
| DLCO / Respiratory function parameters | Respiratory function parameters with DLCO | at 12 Months | 
| Residual volume / Respiratory function parameters | Respiratory function parameters with residual volume | at 12 Months | 
| Total lung capacity / Respiratory function parameters | Respiratory function parameters with total lung capacity | at 12 Months | 
| Arterial stiffness | Arterial stiffness measured by the pulse wave velocity (Complior) | at 12 Months | 
| LVEF / Echocardiography | LVEF measured by echocardiography | at 12 Months | 
| Diastolic dysfunction / Echocardiography | diastolic dysfunction measured by echocardiography | at 12 Months | 
| PAPS / Echocardiography | PAPS measured by echocardiography | at 12 Months | 
| Skeletal muscle index | Skeletal muscle index evaluated by IDEXA | at 12 Months | 
| Muscle function | Muscle strength by grip and pinch | at 12 Months | 
| Hospital Anxiety and Depression scale | Measurement of anxiety symptoms or depression via the Hospital Anxiety and Depression scale. | at 12 Months | 
| Numbers of deaths | Numbers of deaths | at 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incident Chronic Obstructive Pulmonary Disease, comorbidities, trajectories