Follow-up of Spanish Prospective Asthma and Nasal Polyposis Registry (MEGA)

March 7, 2024 updated by: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Joaquin S Sastre
  • Phone Number: 34609835363
  • Email: jsastre@fjd.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
real-life
Other Names:
  • biologics
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
real-life
Other Names:
  • biologics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between non-invasive T2 biomarkers versus biomarkers in sputum
Time Frame: at date of randomization and after one year of follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of treatable traits on asthma control by ACT questionnaire
Time Frame: at date of randomization and after one, two and three years of follow-up
asthma control by Asthma Control Questionnaire (ACT)
at date of randomization and after one, two and three years of follow-up
To characterize asthma exacerbations.
Time Frame: at date of randomization and after one, two and three years of follow-up
number of exacerbations, type of exacerbation, ICU admissions, treatment compliance
at date of randomization and after one, two and three years of follow-up
Analysis of withdrawing asthma medications
Time Frame: at date of randomization and after one, two and three years of follow-up
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
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)
Time Frame: at date of randomization and after one year of follow-up
number of exacerbations
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)
Time Frame: at date of randomization and after one year of follow-up
Total IgE
at date of randomization and after one year of follow-up
Role of alarmins and IL-6 in the component of inflammation in asthma
Time Frame: at date of randomization and after one year of follow-up
measure of TSLP, IL-33 e IL-25 in blood and sputum
at date of randomization and after one year of follow-up
Role of microRNAs in asthma diagnosis and variations after different treatments
Time Frame: 1 year
expression of mRNAs in blood and sputum
1 year
Immunophenotype eosinophils
Time Frame: 1 year
single-cell analysis of eosinophils in blood and sputum at baseline
1 year
Stability of asthma phenotypes along the follow-up
Time Frame: at date of randomization and after one, two and three years of follow-up
% of eosinophils in sputum sample
at date of randomization and after one, two and three years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Collaborators

Sanofi

Investigators

  • Study Director: Joaquin Sastre, Fundacion Jimenez Diaz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

January 2, 2026

Study Completion (Estimated)

January 2, 2026

Study Registration Dates

First Submitted

November 2, 2023

First Submitted That Met QC Criteria

December 1, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGZ-2022-13739

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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