Follow-up of Spanish Prospective Asthma and Nasal Polyposis Registry

Chronic Asthma Clinical Trial

— MEGA  

Official title:

Follow-up of Spanish Prospective Asthma and Nasal Polyposis Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06163807
• Other study ID #: SGZ-2022-13739
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: January 2, 2026

Study information

• Verified date: October 2023
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: Joaquin S Sastre
• Phone: 34609835363
• Email: jsastre[@]fjd.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: January 2, 2026
• Est. primary completion date: January 2, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Chronic Asthma
• Nasal Polyps

Intervention

Drug:
• Antiasthmatic
real-life

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz	Sanofi

References & Publications (10)

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 — View Citation

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, Olaguib — View Citation

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 — View Citation

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 — View Citation

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, P — View Citation

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, P — View Citation

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, Valver — View Citation

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 — View Citation

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( — View Citation

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, Pic — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Analysis of treatable traits on asthma control by ACT questionnaire	asthma control by Asthma Control Questionnaire (ACT)	at date of randomization and after one, two and three years of follow-up
Secondary	To characterize asthma exacerbations.	number of exacerbations, type of exacerbation, ICU admissions, treatment compliance	at date of randomization and after one, two and three years of follow-up
Secondary	Analysis of withdrawing asthma medications	percentage of anti-asthmatic medication withdrawn from the pharmacy in the electronic prescription with respect to that prescribed in your treatment	at date of randomization and after one, two and three years of follow-up
Secondary	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)	number of exacerbations	at date of randomization and after one year of follow-up
Secondary	Analysis of clinical outcomes, pulmonary function tests, biomarkers patients with very low total IgE ( < 10 UI/L)	Total IgE	at date of randomization and after one year of follow-up
Secondary	Role of alarmins and IL-6 in the component of inflammation in asthma	measure of TSLP, IL-33 e IL-25 in blood and sputum	at date of randomization and after one year of follow-up
Secondary	Role of microRNAs in asthma diagnosis and variations after different treatments	expression of mRNAs in blood and sputum	1 year
Secondary	Immunophenotype eosinophils	single-cell analysis of eosinophils in blood and sputum at baseline	1 year
Secondary	Stability of asthma phenotypes along the follow-up	% of eosinophils in sputum sample	at date of randomization and after one, two and three years of follow-up