Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2025-12-24 @ 2:01 PM
NCT ID:
NCT04816695
Eligibility Criteria:
Inclusion Criteria:
* Patients with severe COPD (FEV ≤ 50% of theoretical values) hospitalized for exacerbation;
* COPD treated for at least one year with one (or more successive) combination of at least two inhaled drugs: either a Long-Acting Beta2-Adrenergic bronchodilator (LABA) combined with a corticosteroid (CSI), or a LABA combined with a long-acting anti-cholinergic bronchodilator (LAMA), or a triple combination LABA/LAMA/CSI;
* History of at least one severe COPD exacerbation (treated with antibiotics and/or oral corticosteroids) in the two years preceding the study;
* Ex-smokers (at least 6 months of withdrawal) or active daily smokers of more than 10 pack-years;
* Severe dyspnea in basal state before hospitalization (mMRC stage ≥ 2);
* Age between 40 and 85 years old;
* Perfect understanding of the French language;
* Have signed a consent form;
* Be affiliated to a health insurance plan.
Exclusion Criteria:
* Re-hospitalization for severe exacerbation in the 6 months preceding the study;
* Chronic inflammatory disease (rheumatic, etc...) treated with systemic corticosteroid therapy;
* Long-term oxygen therapy (exclusive ambulatory oxygen therapy is not a non-inclusion criterion);
* Unstable cardiovascular pathology (right or left heart failure, coronary artery disease);
* Cancer under treatment or follow-up;
* Pregnant women;
* Deprived of liberty or under guardianship.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT04816695
Study Brief:
Protocol Section:
NCT04816695