Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age> 35 years
Smoking > 20 PA
Active smoking (cessation < 1 month)
Signature of consent to participate in Phase I of the study
Disqualifiers
Known COPD
Cancer being treated
No affiliation to the social security or other social protection scheme
Pregnant or lactating woman
Trial design
Design model
Single group
Treatments tested in this trial
Exhaustive exploration
Other intervention* clinical investigations * imagery * blood assessment * functional respiratory investigations * muscle function / skeletal muscle index
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Exhaustive explorationOther 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
at 12 MonthsSecondary outcomes
1
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
Time frame
at 3 Months and 6 Months2
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
Time frame
at 3 Months, 6 Months and 12 Months3
Number of steps
Number of steps in the month preceding the visit evaluated by a pedometer
Time frame
at 3 Months, 6 Months and 12 Months4
Forced Expiratory Volume in one second (FEV1)
Forced Expiratory Volume in one second (FEV1)
Time frame
at 3 Months, 6 Months and 12 MonthsSponsors and contacts
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Source ClinicalTrials.gov