NCT06163807招募中不适用
Follow-up of Spanish Prospective Asthma and Nasal Polyposis Registry
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz8 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2025年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 8
- 主要终点
- Correlation between non-invasive T2 biomarkers versus biomarkers in sputum
研究概览
简要总结
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).
详细描述
Open-labeled National, Multicenter Non-interventional on the therapeutic strategy, Prospective (longitudinal) Disease registry, 3 years of follow-up
- Correlation between non-invasive T2 markers (FeNO, blood eosinophils) versus inflammatory markers in sputum (eosinophils, periostin, NO, etc.)
- Cluster analysis in both cohorts.
- Analysis of some treatable traits on asthma control in MEGA cohort (BMI, anxiety and depression scale, exercise).
- To characterize exacerbations (numbers, ICU admissions, treatments compliance, etc).
- Analysis of compliance with asthma medications.
- Analysis of patients with phenotype T2-LOW in MEGA cohort.
- Analysis of patients with undetectable total IgE ( < 10 UI/L).
- Role of microRNA in diagnosis, follow-up and variations after treatments.
- Analysis of alarmins (TSLP, IL-33 e IL-25) and IL-6 in blood and sputum.
- To Immunophenotype eosinophils by single-cell analysis in blood and sputum at baseline and post-biological treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Antiasthmatic (Drug)
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
干预措施: Antiasthmatic (Drug)
结局指标
主要结局
Correlation between non-invasive T2 biomarkers versus biomarkers in sputum
时间窗: 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
次要结局
- Analysis of treatable traits on asthma control by ACT questionnaire(at date of randomization and after one, two and three years 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)
- Role of alarmins and IL-6 in the component of inflammation in asthma(at date of randomization and after one year 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)
- Immunophenotype eosinophils(1 year)
- 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)
- Role of microRNAs in asthma diagnosis and variations after different treatments(1 year)
- Stability of asthma phenotypes along the follow-up(at date of randomization and after one, two and three years of follow-up)
研究者
研究点 (8)
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