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 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT04529993
Eligibility Criteria:
Inclusion Criteria:
* Absence of acute pathology
* Absence of symptom evoking an evolutionary pathology
For healthy volunteers :
* Non-smoker (active or passive) or ex-smoker of less than 5 packet-years and quit for more than 10 years.
* Absence of known significant chronic pathology
* Normal Respiratory Function Test (RFT)
* Woman of childbearing age using an effective method of contraception
For COPD patients :
* Diagnosis of COPD based on dyspnea, chronic cough or sputum production, a history of recurrent lower respiratory tract infections and/or a history of exposure to risk factors for the disease associated with spirometry that demonstrates a post-bronchodilator FEV1/FVC ratio \< 0.70 and lack of reversibility.
* Stage GOLD 1 (post-bronchodilator FEV1 ≥ 80% theoretical) or 2 (post-bronchodilator FEV1 between 50 and less than 80% theoretical) or 3 (post-bronchodilator FEV1 between 30 and less than 50% theoretical) For IPF patients
* Diagnosis of idiopathic pulmonary fibrosis made less than 5 years ago on the basis of scannographic and/or histological criteria and validated at a consultation meeting on interstitial pathology according to the ATS/ERS/JRS/ALAT 2018 recommendations.
Exclusion Criteria:
* Recent rhino-bronchial infection (\< 6 weeks)
* Subjects on antiplatelet or other anticoagulant medication at risk of bleeding during sampling.
* Subjects with a history of clinically significant vaginal discomfort (i.e., recurrent or unconsciousness, etc.)
* History of allergy or intolerance to xylocaine and/or propofol
* History of significant epistaxis (i.e. recurrent epistaxis of any quantity or at least one severe epistaxis)
* Subject at risk of difficult intubation according to the criteria of the 2006 FSSR expert conference\*.
* Pregnant (a urine test will be performed for all women of childbearing age) or breastfeeding woman
For patients :
* Long-term systemic corticosteroid therapy regardless of the reason for the prescription.
* Systemic corticosteroid therapy within the previous 3 months
* Patient on long-term oxygen therapy
* Chronic cardiovascular, neuro-psychic, metabolic pathology in progress, clinically significant or uncontrolled in the last 6 months
* Other associated chronic respiratory pathology (COPD, asbestosis, bronchiectasis ...)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04529993
Study Brief:
Protocol Section:
NCT04529993