Nasal Polyps Clinical Trials

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Follow-up of Spanish Prospective Asthma and Nasal Polyposis Registry

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
Spain
Hospital Del Ferrol
RECRUITING
A Coruña
Hospital Universitario Germans Trias
RECRUITING
Badalona
Hospital Clinic
RECRUITING
Barcelona
Hospital Universitari Vall de Hebron
RECRUITING
Barcelona
Hospital Universitario Sant Pau
RECRUITING
Barcelona
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario de Navarra
RECRUITING
Pamplona
Hospital Universitario Santiago de Compostela
RECRUITING
Santiago De Compostela
Contact Information
Primary
Joaquin S Sastre
jsastre@fjd.es
34609835363
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2026-06-02
Participants
Target number of participants: 1200
Treatments
Asthma patients with different severities
Asthma patients with different severities followed for 5 years. Real-life, antiasthmatic drugs selected by investigators. Clinical, analytical, biomarkers, image techniques
Severe asthma patients treated with biologics
In follow-up for 3 years and new patients. Real-life, antiasthmatic drugs selected by investigators. Clinical, analytical, biomarkers, image techniques
Related Therapeutic Areas
Sponsors
Leads: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators: Sanofi

This content was sourced from clinicaltrials.gov