NCT06163807 Follow-up of Spanish Prospective Asthma and Nasal Polyposis Registry
| NCT ID | NCT06163807 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz |
| Condition | Chronic Asthma |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2026-06-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,200 participants in total. It began in 2025-02-01 with a primary completion date of 2026-06-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Joaquin Sastre
STUDY DIRECTOR
Fundacion Jimenez Diaz
Frequently Asked Questions
Who can join the NCT06163807 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Chronic Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06163807 currently recruiting?
Yes, NCT06163807 is actively recruiting participants. Contact the research team at jsastre@fjd.es for enrollment information.
Where is the NCT06163807 trial being conducted?
This trial is being conducted at Santiago de Compostela, Spain, Badalona, Spain, Barcelona, Spain, Barcelona, Spain and 4 additional locations.
Who is sponsoring the NCT06163807 clinical trial?
NCT06163807 is sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. The principal investigator is Joaquin Sastre at Fundacion Jimenez Diaz. The trial plans to enroll 1,200 participants.
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