Follow-up of Spanish Prospective Asthma and Nasal Polyposis Registry — MEGA  

Chronic Asthma Clinical Trial

Official title: Follow-up of Spanish Prospective Asthma and Nasal Polyposis Registry

Status Not yet recruiting

Clinical Trial 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).

Clinical Trial Description

Open-labeled National, Multicenter Non-interventional on the therapeutic strategy, Prospective (longitudinal) Disease registry, 3 years of follow-up

1. Correlation between non-invasive T2 markers (FeNO, blood eosinophils) versus inflammatory markers in sputum (eosinophils, periostin, NO, etc.)

2. Cluster analysis in both cohorts.

3. Analysis of some treatable traits on asthma control in MEGA cohort (BMI, anxiety and depression scale, exercise).

4. To characterize exacerbations (numbers, ICU admissions, treatments compliance, etc).

5. Analysis of compliance with asthma medications.

6. Analysis of patients with phenotype T2-LOW in MEGA cohort.

7. Analysis of patients with undetectable total IgE ( < 10 UI/L).

8. Role of microRNA in diagnosis, follow-up and variations after treatments.

9. Analysis of alarmins (TSLP, IL-33 e IL-25) and IL-6 in blood and sputum.

10. To Immunophenotype eosinophils by single-cell analysis in blood and sputum at baseline and post-biological treatment. ;

Related Conditions & MeSH terms

• Asthma
• Chronic Asthma
• Nasal Polyps

• NCT number: NCT06163807
• Study type: Observational [Patient Registry]
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: Joaquin S Sastre
• Phone: 34609835363
• Email: jsastre@fjd.es
• Status: Not yet recruiting
• Start date: April 1, 2024
• Completion date: January 2, 2026