Chronic Obstructive Pulmonary Disease, Smokers
Conditions
Keywords
Incident Chronic Obstructive Pulmonary Disease, comorbidities, trajectories
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.
Interventions
OTHERExhaustive exploration
* clinical investigations * imagery * blood assessment * functional respiratory investigations * muscle function / skeletal muscle index
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Numbers of deaths | at 12 Months | Numbers of deaths |
| 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 3 Months, 6 Months and 12 Months | Anxious symptoms or depressions |
| FEV 1 / Respiratory function parameters | at 12 Months | Respiratory function parameters with FEV 1 |
| DLCO / Respiratory function parameters | at 12 Months | Respiratory function parameters with DLCO |
| 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 scores |
| Total lung capacity / Respiratory function parameters | at 12 Months | Respiratory function parameters with total lung capacity |
| Arterial stiffness | at 12 Months | Arterial stiffness measured by the pulse wave velocity (Complior) |
| LVEF / Echocardiography | at 12 Months | LVEF measured by echocardiography |
| Diastolic dysfunction / Echocardiography | at 12 Months | diastolic dysfunction measured by echocardiography |
| PAPS / Echocardiography | at 12 Months | PAPS measured by echocardiography |
| Skeletal muscle index | at 12 Months | Skeletal muscle index evaluated by IDEXA |
| Muscle function | at 12 Months | Muscle strength by grip and pinch |
| Residual volume / Respiratory function parameters | at 12 Months | Respiratory function parameters with residual volume |
Countries
France
Contacts
Primary ContactLaurent BOYER, MD
Backup ContactLila KACI
Outcome results
None listed