Primary objective \- To study the stability of different phenotypes and endotypes of asthma at 3, 5, and 7 years of follow-up and - in MEGA COHORT and in patients on biologic treatment Secondary objective(s) * To study biomarkers variation post-treatment in patients with and without Nasal Polyposis * To demonstrate the existence of different subtypes of eosinophils that may be phenotypically and functionally heterogeneous * To increase the number of patients in the cohort on biologic treatment to reach at least 900 (400 over the current cohort).
Open-labeled National, Multicenter Non-interventional on the therapeutic strategy, Prospective (longitudinal) Disease registry, 3 years of follow-up 1. Correlation between non-invasive T2 markers (FeNO, blood eosinophils) versus inflammatory markers in sputum (eosinophils, periostin, NO, etc.) 2. Cluster analysis in both cohorts. 3. Analysis of some treatable traits on asthma control in MEGA cohort (BMI, anxiety and depression scale, exercise). 4. To characterize exacerbations (numbers, ICU admissions, treatments compliance, etc). 5. Analysis of compliance with asthma medications. 6. Analysis of patients with phenotype T2-LOW in MEGA cohort. 7. Analysis of patients with undetectable total IgE ( \< 10 UI/L). 8. Role of microRNA in diagnosis, follow-up and variations after treatments. 9. Analysis of alarmins (TSLP, IL-33 e IL-25) and IL-6 in blood and sputum. 10. To Immunophenotype eosinophils by single-cell analysis in blood and sputum at baseline and post-biological treatment.
Study Type
OBSERVATIONAL
Enrollment
1,200
real-life
Correlation between non-invasive T2 biomarkers versus biomarkers in sputum
biomarkers in blood (eosinophils, mRNA, periostine), exhaled nitric oxide (FeNO), sputum cell analysis and mRNA expression
Time frame: at date of randomization and after one year of follow-up
Analysis of treatable traits on asthma control by ACT questionnaire
asthma control by Asthma Control Questionnaire (ACT)
Time frame: at date of randomization and after one, two and three years of follow-up
To characterize asthma exacerbations.
number of exacerbations, type of exacerbation, ICU admissions, treatment compliance
Time frame: at date of randomization and after one, two and three years of follow-up
Analysis of withdrawing asthma medications
percentage of anti-asthmatic medication withdrawn from the pharmacy in the electronic prescription with respect to that prescribed in your treatment
Time frame: at date of randomization and after one, two and three years of follow-up
Analysis of patients with phenotype T2-LOW (IgE less than 75 kU/L, blood eosinophils less than 150 cells/μL, and FeNO less than 20 ppb)
number of exacerbations
Time frame: at date of randomization and after one year of follow-up
Analysis of clinical outcomes, pulmonary function tests, biomarkers patients with very low total IgE ( < 10 UI/L)
Total IgE
Time frame: at date of randomization and after one year of follow-up
Role of alarmins and IL-6 in the component of inflammation in asthma
measure of TSLP, IL-33 e IL-25 in blood and sputum
Time frame: at date of randomization and after one year of follow-up
Role of microRNAs in asthma diagnosis and variations after different treatments
expression of mRNAs in blood and sputum
Time frame: 1 year
Immunophenotype eosinophils
single-cell analysis of eosinophils in blood and sputum at baseline
Time frame: 1 year
Stability of asthma phenotypes along the follow-up
% of eosinophils in sputum sample
Time frame: at date of randomization and after one, two and three years of follow-up
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