Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- 1-year adverse evolution
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Exhaustive exploration
Exhaustive exploration of newly diagnosed COPD patients (pulmonary pathology and associated comorbidities)
Intervention: Exhaustive exploration (Other)
Outcomes
Primary Outcomes
1-year adverse evolution
Time Frame: 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 Outcomes
- Adverse evolution(at 3 Months and 6 Months)
- DLCO / Respiratory function parameters(at 12 Months)
- Residual volume / Respiratory function parameters(at 12 Months)
- Arterial stiffness(at 12 Months)
- Numbers of deaths(at 12 Months)
- Exacerbation(at 3 Months, 6 Months and 12 Months)
- FEV 1 / Respiratory function parameters(at 12 Months)
- Total lung capacity / Respiratory function parameters(at 12 Months)
- Skeletal muscle index(at 12 Months)
- Number of steps(at 3 Months, 6 Months and 12 Months)
- Forced Expiratory Volume in one second (FEV1)(at 3 Months, 6 Months and 12 Months)
- Hospital Anxiety and Depression scale(at 12 Months)
- Diastolic dysfunction / Echocardiography(at 12 Months)
- PAPS / Echocardiography(at 12 Months)
- Muscle function(at 12 Months)
- LVEF / Echocardiography(at 12 Months)
- Hospital Anxiety and Depression scale(at 3 Months, 6 Months and 12 Months)