Cohort study on newly diagnosed COPD in smokers
Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)
This study is testing how well screening smokers for COPD in regular doctor visits can help identify new patients and track their health over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Créteil, Île-de-France Region) |
| Trial ID | NCT04252781 on ClinicalTrials.gov |
What this trial studies
This study aims to systematically screen smokers for Chronic Obstructive Pulmonary Disease (COPD) using spirometry in general medicine settings. It will include 1500 smokers, with the goal of identifying 300 newly diagnosed COPD patients, equally divided by gender. The study will explore the evolution of these patients' conditions based on their initial phenotype and management strategies. By documenting the trajectories of these patients, the study seeks to provide valuable insights into the real-life management of COPD.
Who should consider this trial
Good fit: Ideal candidates for this study are smokers over the age of 35 with a significant smoking history who are actively smoking.
Not a fit: Patients with known COPD or those undergoing treatment for cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of COPD in smokers, potentially reducing healthcare costs and improving patient outcomes.
How similar studies have performed: Other studies have shown success with systematic screening approaches for COPD, indicating potential for this study's methodology.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Créteil, Île-de-France Region
- Hopital Henri MONDOR — Créteil, Île-de-France Region, France (Recruiting)
Study contacts
- Principal investigator: Laurent BOYER, MD — Assistance Publique Hôpitaux de Paris (AP-HP)
- Study coordinator: Laurent BOYER, MD
- Email: laurent.boyer@aphp.fr
- Phone: (0) 1 49 81 26 90
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.