An observational study in Chronic Asthma, sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. Recruiting at 8 sites in Spain. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Observational
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)
Open-labeled National, Multicenter Non-interventional on the therapeutic strategy, Prospective (longitudinal) Disease registry, 3 years of follow-up
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 158 across 1,250 observational studies indexed under Asthma.
Browse Asthma studies →Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz is the lead sponsor of 76 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with asthma (intermittent, mild, moderate or severe asthma according to the GINA classification), with or without nasal polyposis attended third-level hospitals of the Spanish National Health System.
Inclusion Criteria:
For the general asthma cohort (MEGA):
Inclusion criteria for asthma patients treated with biologics
Exclusion Criteria:
Exclusion criteria for MEGA COHORT
Exclusion criteria for asthma patients treated with biologics
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Asthma patients with different severities followed for 5 years. Real-life, antiasthmatic drugs selected by investigators. Clinical, analytical, biomarkers, image techniques
Drug: Antiasthmatic
In follow-up for 3 years and new patients. Real-life, antiasthmatic drugs selected by investigators. Clinical, analytical, biomarkers, image techniques
Drug: Antiasthmatic
real-life
Also known as: biologics
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
Plan to share: No
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Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz