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 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT04868357
Eligibility Criteria:
Inclusion Criteria:
* Aged \> 30.
* Affiliated to a Social Security scheme or beneficiary of such a scheme.
* Absence of cognitive disease questioning the validity of patient reported outcomes
* Ability to give free, informed consent.
* Adult patients with severe COPD, dyspnea ; with distension.
* Hospitalized at the CHB.
* Predicted FEV1 and FEV/FVC percentages consistent with severe COPD according to GOLD standards.
* mMRC \>= 2.
* Exposure to tobbacco \>= 10 packs/yrs.
Exclusion Criteria:
* Pregnancy
* Known severe cardiac insufficiency.
* Known severe pulmonary arterial hypertension.
* Evolutive-cancer diagnosis.
* Significant cognitive impairment, hypercapnic encephalopathy or confusional syndrome.
* Deafness.
* Anemia ≤ 8g/dL.
* Psychotic pathology.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
90 Years
Study:
NCT04868357
Study Brief:
Protocol Section:
NCT04868357