Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)

NCT ID: NCT04252781

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-20
• Study Completion Date: 2026-02-20

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.

Conditions

Smokers; Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Exhaustive exploration

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

Group Type: OTHER

Exhaustive exploration

Intervention Type: OTHER

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

Interventions

Exhaustive exploration

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age> 35 years
• Smoking > 20 PA
• Active smoking (cessation < 1 month)
• Signature of consent to participate in Phase I of the study

• 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

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent BOYER, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hôpitaux de Paris (AP-HP)

Locations

Hopital Henri MONDOR

Créteil, Île-de-France Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

Laurent BOYER, MD

Role: CONTACT

laurent.boyer@aphp.fr

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

Lila KACI

Role: CONTACT

lila.kaci@aphp.fr

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

Other Identifiers

K180305J

Identifier Type: -

Identifier Source: org_study_id