Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Smokers; Chronic Obstructive Pulmonary Disease

Treatments: Other: Exhaustive exploration

Study type: Interventional

Funder types: Other

Identifiers

NCT04252781

K180305J

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Exhaustive exploration

Other group

Description:

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

Treatment:

Other: Exhaustive exploration