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:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT03187860
Eligibility Criteria:
Inclusion criteria for non smoking controls:
* The subject has given free and informed consent and signed the consent form
* The subject is affiliated with or beneficiary of a medical insurance program
* The subject has never smoked
* No obstructive breathing disorder (forced expiratory volume at one second (FEV1) \>70% of predicted value; the ratio of FEV1 to forced vital capacity (FEV1/FVC) is \> 0.7)
* No known respiratory disease
Inclusion criteria for smokers without COPD:
* The subject has given free and informed consent and signed the consent form
* The subject is affiliated with or beneficiary of a medical insurance program
* Smoker or former smoker (\>= 30 pack years)
* No obstructive breathing disorder (forced expiratory volume at one second (FEV1) \>70% of predicted value; the ratio of FEV1 to forced vital capacity (FEV1/FVC) is \> 0.7)
Inclusion criteria for smokers with COPD:
* The subject has given free and informed consent and signed the consent form
* The subject is affiliated with or beneficiary of a medical insurance program
* Smoker or former smoker (\>= 30 pack years)
* Subject presenting with COPD: FEV1/FVC \< 0.7 (based on spirometry values in the medical file and performed in the 3 months prior to inclusion)
* The subject requires bronchial fibroscopy (decision made by pneumologist)
* COPD of grade "2" or "3" according to GOLD criteria (Global Initiative for Chronic Obstructive Lung Disease)
Inclusion criteria for subjects with severe asthma:
* The subject has given free and informed consent and signed the consent form
* The subject is affiliated with or beneficiary of a medical insurance program
* Non-smoker or former smoker (\<10 pack years)
* Subject presenting with severe asthma: FEV1/FVC \>= 0.7 and FEV1 \< 80%
* The subjects requires bronchial fibroscopy (decision made by pneumologist)
Exclusion criteria:
* The subject has an extensive neoplastic disease
* The subject has another active lung disease (tuberculosis, pulmonary interstitium disease, active or recent pulmonary infection)
* The subject has had a recent psychiatric disorder (within one year prior to inclusion and documented by a specialist consultation)
* Emergency situations (object extractions...)
* Subject consuming illicit drugs or alcohol
* The subject is in an exclusion period determined by a previous study
* The subject is under judicial protection, or is an adult under any kind of guardianship
* It is impossible to correctly inform the patient
* The subject cannot fluently read French
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03187860
Study Brief:
Protocol Section:
NCT03187860