Follow-up of Spanish Prospective Asthma and Nasal Polyposis Registry

NCT06163807 | Recruiting

• 1 other identifier: SGZ-2022-13739
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 8

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).

Conditions

Chronic Asthma

Keywords

asthma; biologics; biomarkers; nasal polyposis; eosinophils

Outcome Measures

Primary Outcomes (1)

• Correlation between non-invasive T2 biomarkers versus biomarkers in sputum

  biomarkers in blood (eosinophils, mRNA, periostine), exhaled nitric oxide (FeNO), sputum cell analysis and mRNA expression

  at date of randomization and after one year of follow-up

Secondary Outcomes (9)

• Analysis of treatable traits on asthma control by ACT questionnaire

  at date of randomization and after one, two and three years of follow-up

• To characterize asthma exacerbations.

  at date of randomization and after one, two and three years of follow-up

• Analysis of withdrawing asthma medications

  at date of randomization and after one, two and three years of follow-up

• Analysis of patients with phenotype T2-LOW (IgE less than 75 kU/L, blood eosinophils less than 150 cells/μL, and FeNO less than 20 ppb)

  at date of randomization and after one year of follow-up

• Analysis of clinical outcomes, pulmonary function tests, biomarkers patients with very low total IgE ( < 10 UI/L)

  at date of randomization and after one year of follow-up

Study Arms (2)

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

Drug: Antiasthmatic

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

Drug: Antiasthmatic

Interventions

Antiasthmatic DRUG

real-life

Also known as: biologics

Asthma patients with different severities; Severe asthma patients treated with biologics

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with asthma (intermittent, mild, moderate or severe asthma according to the GINA classification), with or without nasal polyposis attended third-level hospitals of the Spanish National Health System.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead
• Sanofi: collaborator

Study Sites (8)

Hospital Universitario Santiago de Compostela

Santiago de Compostela, Acoruña, 15706, Spain

RECRUITING

Hospital Universitario Germans Trias

Badalona, BARCELONA, 08916, Spain

RECRUITING

Hospital Universitari Vall de Hebron

Barcelona, BARCELONA, 08035, Spain

RECRUITING

Hospital Clinic

Barcelona, BARCELONA, 08036, Spain

RECRUITING

Hospital Universitario Sant Pau

Barcelona, BARCELONA, 08041, Spain

RECRUITING

Hospital Del Ferrol

A Coruña, LA CORUÑA, 15405, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Related Publications (10)

• Dominguez-Ortega J, Luna-Porta JA, Olaguibel JM, Barranco P, Arismendi E, Barroso B, Betancor D, Bobolea I, Caballero ML, Cardaba B, Cruz MJ, Curto E, Gonzalez-Barcala FJ, Losantos-Garcia I, Martinez-Rivera C, Mendez-Brea P, Mullol J, Munoz X, Picado C, Plaza V, Del Pozo V, Rial MJ, Sastre J, Soto L, Valero A, Valverde-Monge M, Quirce S. Exacerbations Among Patients With Asthma Are Largely Dependent on the Presence of Multimorbidity. J Investig Allergol Clin Immunol. 2023 Jul 27;33(4):281-288. doi: 10.18176/jiaci.0816. Epub 2002 May 3.

  PMID: 35503227 RESULT

• Matabuena M, Salgado FJ, Nieto-Fontarigo JJ, Alvarez-Puebla MJ, Arismendi E, Barranco P, Bobolea I, Caballero ML, Canas JA, Cardaba B, Cruz MJ, Curto E, Dominguez-Ortega J, Luna JA, Martinez-Rivera C, Mullol J, Munoz X, Rodriguez-Garcia J, Olaguibel JM, Picado C, Plaza V, Quirce S, Rial MJ, Romero-Mesones C, Sastre B, Soto-Retes L, Valero A, Valverde-Monge M, Del Pozo V, Sastre J, Gonzalez-Barcala FJ. Identification of Asthma Phenotypes in the Spanish MEGA Cohort Study Using Cluster Analysis. Arch Bronconeumol. 2023 Apr;59(4):223-231. doi: 10.1016/j.arbres.2023.01.007. Epub 2023 Jan 18. English, Spanish.

  PMID: 36732158 RESULT

• Rodrigo-Munoz JM, Canas JA, Sastre B, Rego N, Greif G, Rial M, Minguez P, Mahillo-Fernandez I, Fernandez-Nieto M, Mora I, Barranco P, Quirce S, Sastre J, Del Pozo V. Asthma diagnosis using integrated analysis of eosinophil microRNAs. Allergy. 2019 Mar;74(3):507-517. doi: 10.1111/all.13570. Epub 2018 Oct 11.

  PMID: 30040124 RESULT

• Romero-Mesones C, Cruz MJ, Alobid I, Barroso B, Arismendi E, Barranco P, Betancor D, Bobolea I, Cardaba B, Curto E, Domenech G, Dominguez-Ortega J, Espejo D, Gonzalez-Barcala FJ, Luna-Porta JA, Martinez-Rivera C, Mendez-Brea P, Mullol J, Olaguibel JM, Picado C, Plaza V, Del Pozo V, Quirce S, Rial MJ, Rodrigo-Munoz JM, Sastre J, Serrano S, Soto-Retes L, Valero A, Valverde-Monge M, Munoz X. Disposition of Work-Related Asthma in a Spanish Asthma Cohort: Comparison of Asthma Severity Between Employed and Retired Workers. J Allergy Clin Immunol Pract. 2023 Nov;11(11):3407-3413.e1. doi: 10.1016/j.jaip.2023.06.040. Epub 2023 Jun 28.

  PMID: 37391017 RESULT

• Barroso B, Valverde-Monge M, Betancor D, Gomez-Lopez A, Villalobos-Vilda C, Gonzalez-Cano B, Sastre J. Improvement in Smell Using Monoclonal Antibodies Among Patients With Chronic Rhinosinusitis With Nasal Polyps: A Systematic Review. J Investig Allergol Clin Immunol. 2023 Dec 14;33(6):419-430. doi: 10.18176/jiaci.0939. Epub 2023 Sep 4.

  PMID: 37669083 RESULT

• Baos S, Calzada D, Cremades-Jimeno L, de Pedro M, Sastre J, Picado C, Quiralte J, Florido F, Lahoz C, Cardaba B. Discriminatory Molecular Biomarkers of Allergic and Nonallergic Asthma and Its Severity. Front Immunol. 2019 May 9;10:1051. doi: 10.3389/fimmu.2019.01051. eCollection 2019.

  PMID: 31143187 RESULT

• Baptista-Serna L, Rodrigo-Munoz JM, Minguez P, Valverde-Monge M, Arismendi E, Barranco P, Barroso B, Bobolea I, Canas JA, Cardaba B, Cruz MJ, Curto E, Dominguez-Ortega J, Garcia-Latorre R, Gonzalez-Barcala FJ, Martinez-Rivera C, Mullol J, Munoz X, Olaguibel JM, Picado C, Plaza V, Quirce S, Rial MJ, Sastre B, Soto L, Valero A, Del Pozo V, Sastre J. Anxiety and body mass index affect asthma control: data from a prospective Spanish cohort. J Allergy Clin Immunol Pract. 2022 Mar;10(3):863-866.e1. doi: 10.1016/j.jaip.2021.10.013. Epub 2021 Oct 18. No abstract available.

  PMID: 34673289 RESULT

• Rial MJ, Alvarez-Puebla MJ, Arismendi E, Caballero ML, Canas JA, Cruz MJ, Gonzalez-Barcala FJ, Luna JA, Martinez-Rivera C, Mullol J, Munoz X, Olaguibel JM, Picado C, Plaza V, Quirce S, Romero-Mesones C, Salgado FJ, Sastre B, Soto-Retes L, Valero A, Valverde M, Sastre J, Pozo VD. Clinical and inflammatory characteristics of patients with asthma in the Spanish MEGA project cohort. Clin Transl Allergy. 2021 Mar;11(1):e12001. doi: 10.1002/clt2.12001.

  PMID: 33900052 RESULT

• Betancor D, Olaguibel JM, Rodrigo-Munoz JM, Arismendi E, Barranco P, Barroso B, Bobolea I, Cardaba B, Cruz MJ, Curto E, Del Pozo V, Gonzalez-Barcala FJ, Martinez-Rivera C, Mullol J, Munoz X, Picado C, Plaza V, Quirce S, Rial MJ, Soto L, Valero A, Valverde-Monge M, Sastre J. How reliably can algorithms identify eosinophilic asthma phenotypes using non-invasive biomarkers? Clin Transl Allergy. 2022 Aug 20;12(8):e12182. doi: 10.1002/clt2.12182. eCollection 2022 Aug.

  PMID: 36000018 RESULT

• Rial MJ, Valverde M, Del Pozo V, Gonzalez-Barcala FJ, Martinez-Rivera C, Munoz X, Olaguibel JM, Plaza V, Curto E, Quirce S, Barranco P, Dominguez-Ortega J, Mullol J, Picado C, Valero A, Bobolea I, Arismendi E, Ribo P, Sastre J. Clinical characteristics in 545 patients with severe asthma on biological treatment during the COVID-19 outbreak. J Allergy Clin Immunol Pract. 2021 Jan;9(1):487-489.e1. doi: 10.1016/j.jaip.2020.09.050. Epub 2020 Oct 9. No abstract available.

  PMID: 33045398 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood cells, sputum cells

MeSH Terms

Conditions

Asthma; Nasal Polyps

Interventions

Anti-Asthmatic Agents; Biological Products

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Complex Mixtures

Study Officials

• Joaquin Sastre

  Fundacion Jimenez Diaz

  STUDY DIRECTOR

Central Study Contacts

Joaquin S Sastre

CONTACT

34609835363; jsastre@fjd.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: December 11, 2023
• Study Start: February 1, 2025
• Primary Completion (Estimated): June 2, 2026
• Study Completion (Estimated): June 2, 2026
• Last Updated: March 30, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8)