Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
- Residual volume / Respiratory function parameters [at 12 Months]
Respiratory function parameters with residual volume
- 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
- Hospital Anxiety and Depression scale [at 12 Months]
Measurement of anxiety symptoms or depression via the Hospital Anxiety and Depression scale.
- Numbers of deaths [at 12 Months]
Numbers of deaths
Eligibility Criteria
Criteria
Inclusion Criteria:
Inclusion criteria of smokers with spirometry (pre-inclusion)
-
Age> 35 years
-
Smoking > 20 PA
-
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
-
Chronic inflammatory disease or 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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Principal Investigator: Laurent BOYER, MD, Assistance Publique Hôpitaux de Paris (AP-HP)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- K180305J