\- 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria:
For the general asthma cohort (MEGA):
* Age from 18 to 80 y.o. with asthma with and without nasal polyposis based on GINA guidelines (compatible clinical symptoms+reversibility of at least 12% and 200 mL in FEV1 after the administration of 200-400 μg albuterol/salbutamol or positive methacholine test) of several severities attended at participant centres
* Already in follow-up in MEGA cohort
* To participate in the study
* Signed informed consent
Inclusion criteria for asthma patients treated with biologics
* Patients from 18 to 80 y.o. with uncontrolled asthma with and without nasal polyposis that fulfil criteria to be treated with biological drugs (Existing treatment with medium-to-high-dose ICS (≥ 250 μg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 μg/day of fluticasone propionate or equivalent) in combination with a second controller (e.g., LABA, LTRA) for at least 3 months+ airflow limitation- FEV1 \<80%/FEV1/FVC \<70+ACQ-5 score ≥ 1.5/ ACT \< 19 at inclusion and/or have experience any of the following events on the last year: treatment with systemic steroids/ hospitalization or emergency medical care visit for worsening asthma.
* When planning dupilumab, mepolizumab, benralizumab or reslizumab, biomarker levels, and exacerbation in the previous year will be considered according to the Spanish Ministry of Health recommendations for reimbursement of any biological drug in severe asthma. In the case of Omalizumab allergic asthma and IgE \> 75 and \< 1500 UI
* Patients already in follow-up in the cohort of patients treated with biologics
* Willing to participate in the study
* Sign informed consent
Exclusion Criteria:
* Exclusion criteria for MEGA COHORT
* Diagnosis of chronic obstructive pulmonary disease or other lung disease that may impair lung function
* Comorbid disease that might interfere with the evaluation, e.g. psychiatric disorders
* Patients participating in other clinical trials
* Patients without the capacity to understand the aim of the study
* Exclusion criteria for asthma patients treated with biologics
* Diagnosis of chronic obstructive pulmonary disease or other lung disease that may impair lung function
* Comorbid disease that might interfere with the evaluation, e.g. psychiatric disorders
* Patients participating in other clinical trials
* Patients without the capacity to understand the aim of the study
Primary outcome measure(s)
Correlation between non-invasive T2 biomarkers versus biomarkers in sputum — at date of randomization and after one year of follow-up biomarkers in blood (eosinophils, mRNA, periostine), exhaled nitric oxide (FeNO), sputum cell analysis and mRNA expression
Trial sites (8)
Facility
City
Region
Status
Hospital Universitario Santiago de Compostela
Santiago de Compostela
Acoruña
Recruiting
Hospital Universitario Germans Trias
Badalona
BARCELONA
Recruiting
Hospital Universitari Vall de Hebron
Barcelona
BARCELONA
Recruiting
Hospital Clinic
Barcelona
BARCELONA
Recruiting
Hospital Universitario Sant Pau
Barcelona
BARCELONA
Recruiting
Hospital Del Ferrol
A Coruña
LA CORUÑA
Recruiting
Hospital Universitario La Paz
Madrid
Madrid
Recruiting
Hospital Universitario de Navarra
Pamplona
Navarre
Recruiting
More Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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