Clinical trial NCT06163807: Follow-up of Spanish Prospective Asthma and Nasal Polyposis Registry
Official title: Follow-up of Spanish Prospective Asthma and Nasal Polyposis Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Asthma
Keywords: asthma
biologics
biomarkers
nasal polyposis
eosinophils
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2023-12-11
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

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

Primary outcomes:
measure: Correlation between non-invasive T2 biomarkers versus biomarkers in sputum
timeFrame: at date of randomization and after one year of follow-up
Secondary outcomes:
measure: Analysis of treatable traits on asthma control by ACT questionnaire
timeFrame: at date of randomization and after one, two and three years of follow-up
measure: To characterize asthma exacerbations.
timeFrame: at date of randomization and after one, two and three years of follow-up
measure: Analysis of withdrawing asthma medications
timeFrame: at date of randomization and after one, two and three years of follow-up
measure: 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)
timeFrame: at date of randomization and after one year of follow-up
measure: Analysis of clinical outcomes, pulmonary function tests, biomarkers patients with very low total IgE ( < 10 UI/L)
timeFrame: at date of randomization and after one year of follow-up
measure: Role of alarmins and IL-6 in the component of inflammation in asthma
timeFrame: at date of randomization and after one year of follow-up
measure: Role of microRNAs in asthma diagnosis and variations after different treatments
timeFrame: 1 year
measure: Immunophenotype eosinophils
timeFrame: 1 year
measure: Stability of asthma phenotypes along the follow-up
timeFrame: at date of randomization and after one, two and three years of follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Fundacion Jimenez Diaz
name: Joaquin Sastre
role: STUDY_DIRECTOR
References:
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