Modeling Bronchial Epithelium in Severe Asthma With Human Induced Pluripotent Stem Cells (iPSC) (MOSAIC)
Severe Asthma, Allergic Bronchopulmonary Aspergillosis (ABPA)
About this trial
This is an interventional other trial for Severe Asthma focused on measuring Severe asthma, ABPA, Pluripotent stem cells, Airway epithelium, Eosinophils, Crystal
Eligibility Criteria
Inclusion Criteria: - Smoking < 10 BP and weaned > 1 year. Diagnostic criteria for Severe asthma group T2 : History of severe asthma diagnosed by a physician (according to GINA criteria) Subject on high dose inhaled corticosteroid (ICS 1000 µg beclometasone equivalent) and beta-agonists for at least 6 months prior to inclusion Blood eosinophilia in history (previous years) > 300/mm3 Diagnostic criteria for Allergic bronchopulmonary aspergillosis (ABPA) group - Diagnosis of ABPA defined by the following 3 mandatory criteria: Diagnosis of asthma by the physician for at least 12 months based on the 2019 recommendations of the Global Initiative for Asthma (GINA) group Evidence of hypersensitivity to Aspergillus Fumigatus by skin test (on screening or previous documented positive skin test within the last 12 months), or serum Immunoglobulin E (IgE) specific antibodies to A. Fumigatus (≥ 0.35 kUnit/l) at screening. Elevated total serum IgE (> 1000 IU/ml). If the 3 ancillary criteria for the diagnosis of of ABPA (below) are met, an IgE level ≤ 1,000 IU/ml is acceptable. If the patient is receiving oral corticosteroids (OCs) at screening, a previous documented IgE level >1000 IU/ml within the last 12 months is acceptable. And at least 2 of the following ancillary criteria: Blood eosinophil count >500 cells/μl at screening for patients not receiving OCs at screening. For patients receiving OCs at screening, blood eosinophil count > 500 cells/μl at screening or documented previous eosinophil count > 500 cells/μl in the last 12 months. Presence of precipitating antibodies or serum immunoglobulin G (IgG) to A. Fumigatus at screening. Documented radiological abnormalities consistent with ABPA (such as transient mucoid impaction, hyperdense mucus [high attenuation of mucous plugs], opacities of centro-lobular nodules attenuation of mucous plugs], opacities of centro-lobular nodules, telectasis, bronchiectasis, etc.) by chest X-ray or high-resolution computed tomography (HR-CT) within the last 18 months or at screening. Exclusion Criteria: Other associated respiratory diseases (e.g. chronic obstructive pulmonary disease (COPD), cystic fibrosis) Patient in an exclusion period determined by another protocol Protected populations according to the French public health code: Parturient, nursing or pregnant women; subjects deprived of liberty by judicial or administrative decision; Major protected by law (under any form of guardianship). Lack of informed consent Non-beneficiary of the national health insurance system
Sites / Locations
- university Hospital of Montpellier
Arms of the Study
Arm 1
Experimental
Eligible patients