Observatory of Patients with Severe Asthma and Potential Eligible Patients for Treatment with Biological Drugs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Analyzing epidemiological and clinical characteristics of severe asthmatics from SANI registry.
研究概览
简要总结
The goal of this registry is collecting data of severe asthma patients, recruited by specialized centers, in a real life setting, homogeneously placed on a database management system to follow them over the time.
The information recorded will provide:
- The collection of homogeneous clinical, functional and biologic data of patients with severe asthma in a real life setting.
- The evaluation of adherence to treatment in real life.
- The clinical eligibility of patients treated with biologics.
- The evaluation of patients' clinical response to each treatment.
- The monitoring of tolerability and safety.
- The long-term follow up of patients with severe asthma.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent and privacy disclaimer;
- •age > 12 years;
- •diagnosis of severe asthma according to the ERS/ATS criteria:
- •During treatment with:
- •High-dose ICS + at least one addistional controller (LABA, montelukast, or theophylline) or
- •Oral corticosteroids >6 months/year
- •at least one of the following occurs or would occur if treatment would be reduced:
- •ACT <20 or ACQ>1.5
- •At least 2 exacerbations in the last 12 months
- •At least 1 exacerbation treated in hospital or requiring mechanical ventilation in the last 12 months
- •FEV1 <80% (if FEV1/FVC below the lower limit of normal)
- •Exclusion Criteria have not been considered in order to have a realistic view of severe asthma in real life.
排除标准
- 未提供
结局指标
主要结局
Analyzing epidemiological and clinical characteristics of severe asthmatics from SANI registry.
时间窗: through study completion (the length of the follow up for each patient is scheduled for 10 years)
Collection of clinical data: presence of allergies and/or comorbidities, previous accesses to ER and/or hospitalizations, and numbers of exacerbations.
Collecting functional data of severe asthmatics from SANI registry.
时间窗: through study completion (the length of the follow up for each patient is scheduled for 10 years)
Assessment of lung function before and after a bronchodilator medication: Forced Vital Capacity \[FVC\] and Forced Expiratory Volume in 1 second \[FEV1\] values (percentages) combined to report FEV1/FVC Ratio.
Assessing inflammatory markers in order to characterize asthma endotypes.
时间窗: through study completion (the length of the follow up for each patient is scheduled for 10 years)
Measurement of blood and sputum eosinophil levels (percentages).
Assessing asthma control and and PROs.
时间窗: through study completion (the length of the follow up for each patient is scheduled for 10 years)
Assessment of the quality of life through Asthma Quality of Life Questionnaire \[AQLQ\] .
Studying the real life efficacy and safety of biologics.
时间窗: through study completion (the length of the follow up for each patient is scheduled for 10 years)
Evaluation of patients' clinical response to each biologics, reports of previous adverse reactions to the drug used and reasons for withdrawal from biologic treatment.
次要结局
未报告次要终点