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Clinical Trials in Spain / NCT06163807
Recruiting Observational

Follow-up of Spanish Prospective Asthma and Nasal Polyposis Registry

NCT06163807 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2025-02-01
Last updated
2026-03-30

Condition(s) studied

Chronic Asthma

Investigational drug(s) / intervention(s)

Antiasthmatic

Antiasthmatic: real-life

Study summary

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).

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)

Trial sites (8)

FacilityCityRegionStatus
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

Official registry record

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.

View NCT06163807 on ClinicalTrials.gov ↗ ← All trials in Spain