NCT06163807Recruiting
Follow-up of Spanish Prospective Asthma and Nasal Polyposis Registry
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1200 (estimated)
- First submitted
- 2 Nov 2023
- Start date
- 1 Feb 2025
- Primary completion date
- 2 Jun 2026
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Diseases
- Asthma
- NCT number
- NCT06163807
What you commit to
- Study type: Observational
- Planned participants: 1200
- From 1 Feb 2025 to the primary completion date, 2 Jun 2026
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Del Ferrol Coordinator of this site? Confirm its status | A Coruña | Spain | Recruiting |
| Hospital Universitario Germans Trias Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Universitari Vall de Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinic Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Universitario Santiago de Compostela Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.