Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)
- Conditions
- Chronic Obstructive Pulmonary DiseaseSmokers
- Interventions
- Other: Exhaustive exploration
- Registration Number
- NCT04252781
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Exhaustive exploration Exhaustive exploration Exhaustive exploration of newly diagnosed COPD patients (pulmonary pathology and associated comorbidities)
- Primary Outcome Measures
Name Time Method 1-year adverse evolution at 12 Months 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
- Secondary Outcome Measures
Name Time Method Adverse evolution at 3 Months and 6 Months - 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 scoresDLCO / Respiratory function parameters at 12 Months Respiratory function parameters with DLCO
Residual volume / Respiratory function parameters at 12 Months Respiratory function parameters with residual volume
Arterial stiffness at 12 Months Arterial stiffness measured by the pulse wave velocity (Complior)
Numbers of deaths at 12 Months Numbers of deaths
Exacerbation at 3 Months, 6 Months and 12 Months 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
FEV 1 / Respiratory function parameters at 12 Months Respiratory function parameters with FEV 1
Total lung capacity / Respiratory function parameters at 12 Months Respiratory function parameters with total lung capacity
Skeletal muscle index at 12 Months Skeletal muscle index evaluated by IDEXA
Number of steps at 3 Months, 6 Months and 12 Months Number of steps in the month preceding the visit evaluated by a pedometer
Forced Expiratory Volume in one second (FEV1) at 3 Months, 6 Months and 12 Months Forced Expiratory Volume in one second (FEV1)
Hospital Anxiety and Depression scale at 12 Months Measurement of anxiety symptoms or depression via the Hospital Anxiety and Depression scale.
Diastolic dysfunction / Echocardiography at 12 Months diastolic dysfunction measured by echocardiography
PAPS / Echocardiography at 12 Months PAPS measured by echocardiography
Muscle function at 12 Months Muscle strength by grip and pinch
LVEF / Echocardiography at 12 Months LVEF measured by echocardiography
Trial Locations
- Locations (1)
Hopital Henri MONDOR
🇫🇷Créteil, Ile-De-France, France