Actively Recruiting
Incident Chronic Obstructive Pulmonary Disease Cohort Study (ICONIC)
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-01-09
300
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating smokers to better understand the development and progression of Chronic Obstructive Pulmonary Disease (COPD), especially in those who have not yet been diagnosed. The study focuses on identifying new COPD cases through systematic screening in general medicine and tracking their health outcomes. It aims to distinguish how different initial COPD types evolve over time and how management affects these patients. Participants include smokers aged over 35 with a history of heavy smoking. The study involves thorough investigations including clinical exams, imaging, blood tests, respiratory function tests, and assessments of muscle function. The main group includes newly diagnosed COPD patients who will undergo detailed evaluation to explore lung and related health issues. During the study, participants will be monitored at several points over one year to check lung function, physical activity, mental health, and heart and muscle status. Researchers will track adverse health events, exacerbations, and lung performance using tests like spirometry and echocardiography. The trial aims to gather comprehensive data on the progression of COPD in real-life care settings over 12 months.
CONDITIONS
Brief Title
Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 35 years
- Smoking history greater than 20 pack-years
- Currently actively smoking or cessation less than 1 month
- Signed consent to participate in Phase I
- For COPD patients: FEV1/FVC less than 70% of theoretical value or below lower limit of normal
- Signed consent to participate in Phase II
You will not qualify if you...
- Known COPD diagnosis
- Currently undergoing cancer treatment
- No affiliation to social security or social protection scheme
- Pregnant or lactating women
- Patients deprived of liberty or under legal protection (tutorship or curatorship)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial assessment period
Participants undergo exhaustive explorations including clinical investigations, imagery, blood assessments, functional respiratory investigations, and muscle function tests to diagnose COPD and associated comorbidities.
1 baseline visit (in-person)
Duration - 12 months
Participants are monitored for adverse evolution and clinical outcomes over 12 months with repeated evaluations of respiratory function, muscle function, and psychological status.
Visits at 3 months, 6 months, and 12 months (in-person)
Trial Site Locations
Total: 1 location
1
Hopital Henri MONDOR
Créteil, Île-de-France Region, France, 94000
Actively Recruiting
Research Team
L
Laurent BOYER, MD
L
Lila KACI
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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