Clinical trial NCT04252781: Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)
Official title: Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smokers
Chronic Obstructive Pulmonary Disease
Keywords: Incident Chronic Obstructive Pulmonary Disease
comorbidities
trajectories
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 300
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: 1-year adverse evolution
timeFrame: at 12 Months
Secondary outcomes:
measure: Adverse evolution
timeFrame: at 3 Months and 6 Months
measure: Exacerbation
timeFrame: at 3 Months, 6 Months and 12 Months
measure: Number of steps
timeFrame: at 3 Months, 6 Months and 12 Months
measure: Forced Expiratory Volume in one second (FEV1)
timeFrame: at 3 Months, 6 Months and 12 Months
measure: Hospital Anxiety and Depression scale
timeFrame: at 3 Months, 6 Months and 12 Months
measure: FEV 1 / Respiratory function parameters
timeFrame: at 12 Months
measure: DLCO / Respiratory function parameters
timeFrame: at 12 Months
measure: Residual volume / Respiratory function parameters
timeFrame: at 12 Months
measure: Total lung capacity / Respiratory function parameters
timeFrame: at 12 Months
measure: Arterial stiffness
timeFrame: at 12 Months
measure: LVEF / Echocardiography
timeFrame: at 12 Months
measure: Diastolic dysfunction / Echocardiography
timeFrame: at 12 Months
measure: PAPS / Echocardiography
timeFrame: at 12 Months
measure: Skeletal muscle index
timeFrame: at 12 Months
measure: Muscle function
timeFrame: at 12 Months
measure: Hospital Anxiety and Depression scale
timeFrame: at 12 Months
measure: Numbers of deaths
timeFrame: at 12 Months
Other outcomes:
Locations:
city: Créteil
country: France
facility: Hopital Henri MONDOR
state: Ile-De-France
Study officials:
affiliation: Assistance Publique Hôpitaux de Paris (AP-HP)
name: Laurent BOYER, MD
role: PRINCIPAL_INVESTIGATOR
References: