Spanish long-term follow-up of people with asthma and nasal polyps
Official title: Follow-up of Spanish Prospective Asthma and Nasal Polyposis Registry
Run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · NCT06163807 · Data updated 2026-11-12
This follow-up will track adults with chronic asthma, with and without nasal polyps, to see if their asthma types and biomarkers stay stable over 3, 5, and 7 years, including people on biologic treatments.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 1200 (estimated) |
| Sponsor | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz Academic / other |
| Drugs / interventions | dupilumab, mepolizumab, benralizumab, reslizumab, Omalizumab |
| Locations | 8 sites (Santiago de Compostela, Acoruña and 7 other locations) |
| Status | Recruiting |
| Started | February 1, 2025 |
| Main results expected | June 2, 2026 |
| Study ends | June 2, 2026 |
| Registry record updated | March 30, 2026 |
| Trial ID | NCT06163807 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–80 years with physician-diagnosed asthma (with or without nasal polyposis) who meet GINA criteria and are followed at participating centers, including a subgroup of patients eligible for or already receiving biologic treatment.
✕Probably not a fit
Patients with well-controlled mild asthma who are not on high-intensity controller therapy, children under 18, or those unwilling to provide blood/sputum samples are unlikely to benefit directly from the biologic-focused analyses.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a national, multicenter, prospective, non-interventional registry following adults with chronic asthma across participating Spanish centers. Clinical data, lung function, FeNO, blood and sputum biomarkers, and patient-reported measures will be collected longitudinally with planned analyses at 3, 5, and 7 years and a focused MEGA cohort and biologics subgroup. The protocol includes cluster analyses to define phenotypes/endotypes, comparison of non-invasive T2 markers with sputum inflammatory markers, treatable-trait analyses, and advanced work such as single-cell immunophenotyping of eosinophils and microRNA profiling. Recruitment aims to expand the biologics-treated cohort substantially to enable subgroup and biomarker-response analyses.
Why it matters
Potential benefit: If successful, the registry could help match patients to the most appropriate therapies by linking stable phenotypes and biomarkers to clinical outcomes and biologic response.
How similar studies have gone: Previous asthma registries and biomarker studies have linked T2 markers to clinical phenotypes and documented benefits of biologics, but large-scale single-cell eosinophil immunophenotyping and some alarmin analyses in this setting remain relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Hospital Universitario Santiago de Compostela
Santiago de Compostela, Acoruña, Spain Recruiting -
Hospital Universitario Germans Trias
Badalona, Barcelona, Spain Recruiting -
Hospital Universitari Vall de Hebron
Barcelona, Barcelona, Spain Recruiting -
Hospital Clinic
Barcelona, Barcelona, Spain Recruiting -
Hospital Universitario Sant Pau
Barcelona, Barcelona, Spain Recruiting -
Hospital Del Ferrol
A Coruña, La Coruña, Spain Recruiting
Show 2 more locations
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Hospital Universitario La Paz
Madrid, Madrid, Spain Recruiting -
Hospital Universitario de Navarra
Pamplona, Navarre, Spain Recruiting
Study contacts
- Study coordinator: Joaquin S Sastre
- Email: jsastre@fjd.es
- Phone: 34609835363
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.