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 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT03181204
Eligibility Criteria:
Inclusion Criteria for COPD patients:
* The patient has given his/her signed, informed consent
* Forced expiratory volume in 1 second / forced vital capacity \< 0.7 \[FEV1/FVC \< 0.7\]
* FEV1 \< 50% of predicted value
* Exclusion of other respiratory pathologies, based on anamnesis, computed tomography and complementary respiratory function tests and transthoracic ultrasound,
* Smoking \>10 pack-years, ongoing or weaned
* Absence of exacerbation or intercurrent infectious episode for at least 4 weeks at time of inclusion
* Medical indication for a bronchial fibroscopy (indication validated by the physician in charge of the patient and the study investigating physician): pulmonary peripheral nodule exploration with computed tomography, interventional endoscopy for emphysema reduction, removal of foreign bodies, other indications.
* Absence of contraindications for bronchial biopsy (left to physician's discretion): not limited to: regular intake of anticoagulants or anti-platelet aggregation, hemostasis abnormalities
Inclusion Criteria for smokers:
* The patient has given his/her signed, informed consent
* Forced expiratory volume in 1 second / forced vital capacity \> 0.7 \[FEV1/FVC \> 0.7\]
* FEV1 \> 80% of predicted value
* Exclusion of other respiratory pathologies, based on anamnesis, computed tomography (absence of extensive emphysema lesions defined by the presence of less than \<5% relative surface area occupied by densities less than 910 UH (measured on millimeter cuts)) and respiratory function tests (Residual Volume \<120%, Diffusion Capacity for Carbon Monoxide \> 60% and Total Pulmonary Capacity\> 120%) and transthoracic ultrasound (normal),
* Smoking \>40 pack-years, ongoing or weaned
* Absence of exacerbation or intercurrent infectious episode for at least 4 weeks at time of inclusion
* Medical indication for a bronchial fibroscopy (indication validated by the physician in charge of the patient and the study investigating physician): pulmonary peripheral nodule exploration with computed tomography, interventional endoscopy for emphysema reduction, removal of foreign bodies, other indications.
* Absence of contraindications for bronchial biopsy (left to physician's discretion): not limited to: regular intake of anticoagulants or anti-platelet aggregation, hemostasis abnormalities
Exclusion Criteria:
* Contra-indication for bronchial fibroscopy and cutaneous biopsy
* Deficiency in α-1 antitrypsin
* Significant bronchiectasis on chest computed tomography scan
* Colonization of the airways by Pseudomonas Aeroginosa or Aspergillus
* Chemotherapy or other cytotoxic treatments in the last 12 months
* Systemic corticotherapy in the 4 weeks prior to inclusion
* Long-term antibiotic treatment, notably by macrolides
* Any other treatment that may affect the bronchial epithelium, this being left to the discretion of the investigating physician
* Consumer of illicit drugs or alcohol
* Participant in an exclusion period determined by a previous study
* Subject not affiliated with, or not beneficiary of, a social security plan.
* Pregnant or nursing women according to Article L1121-5 of the Public Health Code.
* Vulnerable persons according to Article L1121-6 of the Public Health Code
* An adult who is protected or incapable of giving consent in accordance with Article L1121-8 of the Public Health Code
* Subject deprived of freedom by judicial or administrative decision.
* Those patients for whom two epithelia cultures (1 from bronchial biopsy ("ALI") and 1 from fibroblast reprogrammation of redifferentiated iPS ("iALI")) were not obtained will be excluded (post-inclusion).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03181204
Study Brief:
Protocol Section:
NCT03181204