Spanish long-term follow-up of people with asthma and nasal polyps

Follow-up of Spanish Prospective Asthma and Nasal Polyposis Registry

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
• Enrollment: 1200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz (other)
• Drugs / interventions: dupilumab, mepolizumab, benralizumab, reslizumab, Omalizumab
• Locations: 8 sites (Santiago de Compostela, Acoruña and 7 other locations)
• Trial ID: NCT06163807 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Santiago de Compostela, Acoruña and 7 other locations

• 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)
• Hospital Universitario La Paz — Madrid, Madrid, Spain (RECRUITING)
• Hospital Universitario de Navarra — Pamplona, Navarre, Spain (RECRUITING)

Study contacts

• Study coordinator: Joaquin S Sastre

Conditions: Chronic Asthma, asthma, biologics, biomarkers, nasal polyposis, eosinophils