Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC) (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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; Smokers
• Intervention / Treatment: Other: Exhaustive exploration

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laurent BOYER, MD; Phone Number: + 33 (0) 1 49 81 26 90; Email: laurent.boyer@aphp.fr
• Study Contact Backup: Name: Lila KACI; Phone Number: +33 (0) 1 49 81 36 24; Email: lila.kaci@aphp.fr

Study Locations

• France
  • Ile-De-France
    • Créteil, Ile-De-France, France, 94000
      • Recruiting
      • Hôpital Henri Mondor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Laurent BOYER, MD, Assistance Publique Hôpitaux de Paris (AP-HP)

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2020
• Primary Completion (Actual): January 7, 2025
• Study Completion (Estimated): February 20, 2026

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: comorbidities; trajectories; Incident Chronic Obstructive Pulmonary Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: K180305J

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No