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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exhaustive exploration | Other | Exhaustive exploration of newly diagnosed COPD patients (pulmonary pathology and associated comorbidities) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exhaustive exploration | Other |
|
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| 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 |
| 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 |
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Inclusion Criteria:
Inclusion criteria of smokers with spirometry (pre-inclusion)
Inclusion criteria for patients with incidental COPD
After screening, an equal number of men and women COPD will be included (91 men and 92 women).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurent BOYER, MD | Contact | (0) 1 49 81 26 90 | + 33 | laurent.boyer@aphp.fr |
| Lila KACI | Contact | (0) 1 49 81 36 24 | +33 | lila.kaci@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Laurent BOYER, MD | Assistance Publique Hôpitaux de Paris (AP-HP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Henri MONDOR | Recruiting | Créteil | Île-de-France Region | 94000 | France |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| 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 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |