RIsk Factors, Diagnosis, and Management of SEvere/Uncontrolled Asthma From General Population to Clinical Setting: Update and Follow-up of the RItA Registry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 422
- 试验地点
- 4
- 主要终点
- Change of use of biologic therapy (number)
研究概览
简要总结
Within the AGAVE project (2010-2014), funded by the 2008 AIFA (Italian Medicines Agency) Call (contract No. FARM8YRYZC), a severe/uncontrolled asthma online Registry (RItA) was implemented to assess the appropriateness of therapeutic strategies for severe/uncontrolled asthma patients, according to GINA (Global Initiative for Asthma) guidelines, in epidemiological and clinical samples. The online RItA Registry is a database containing information on patients' general characteristics, medical history, clinical data, risk factors, comorbidity, asthma exacerbations, current asthma treatment. Currently, it contains information on severe/uncontrolled asthma subjects, enrolled at national level, performing baseline (n tot=1018) and follow-up interviews (n tot=402).
Aim of the RISER study is to increase knowledge about the risk factors, diagnosis, and management of severe/uncontrolled asthma in general population and clinical setting through the update and follow-up of the RItA registry.
The RISER study is an observational longitudinal study involving a clinical setting and an epidemiological one.
The field survey will comprise one or two follow-ups according to the sample.
- Observational longitudinal study in hospital specialist centres (clinical sample). Clinical cases of severe/uncontrolled asthma already included in the online RItA Registry and new clinical cases of severe/uncontrolled asthma attending the clinical centres and not yet included in the online RItA Registry, will be investigated at T0, T6 and T12 through a clinical form in order to collect information in accordance with the online RItA registry, and routine clinical/functional tests of asthma control.
- Observational longitudinal study in a general population sample (epidemiological sample). Epidemiological cases of severe/uncontrolled asthma from Pisa cohort already inserted in the online RItA Registry and new epidemiological cases of severe/uncontrolled asthma from pre-existing Pisa cohort not yet included in the online RItA Registry will be investigated at T0 and T12 through a questionnaire to collect information for feeding the online RItA registry. Subjects fitting the epidemiological definition of severe/uncontrolled asthma will be invited at the Pisa clinical centre to have routine clinical/functional tests.
All data collected from clinical/epidemiological centres will be included in the RItA registry.
Overall, it is expected to enroll 422 patients.
详细描述
RISER study is an observational longitudinal study in epidemiological and clinical samples investigated through questionnaires/clinical forms and routine clinical/functional assessments at baseline and at follow-ups.
The study is constituted by two arms:
- observational longitudinal study in hospital specialist centres (clinical sample);
- observational longitudinal study in a general population sample (epidemiological sample).
The clinical sample will provide a new characterization of severe/uncontrolled asthma phenotypes through clinical and functional assessments and biomarkers.
The epidemiological sample will allow to obtain new information about risk/protective factors for severe/uncontrolled asthma and to identify new cases who have not been yet referred to clinical centres.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change of use of biologic therapy (number)
时间窗: Analyzed at baseline, month 6 and month 12.
- biologic therapy (number of months)
Change of use of systemic steroids (number)
时间窗: Analyzed at baseline, month 6 and month 12.
- systemic steroids (number of courses)
Change of asthma control test (score)
时间窗: Analyzed at baseline, month 6 and month 12.
- asthma control test - ACT (score range 5-25, with higher scores indicating greater asthma control) (mean score)
Change of asthma exacerbations (number)
时间窗: Analyzed at baseline, month 6 and month 12.
- asthma exacerbations (mean number)
Change of asthma control questionnaire (score)
时间窗: Analyzed at baseline, month 6 and month 12.
- asthma control questionnaire - ACQ (score range 0- 6, with lower scores indicating greater asthma control) (mean score)
次要结局
- Quality of life (score)(Analyzed at baseline, month 6 and month 12.)
- Health services use-hospitalization(Analyzed at baseline, month 6 and month 12.)
- Impairment of work/school (number)(Analyzed at baseline, month 6 and month 12.)
- Health services use-emergency department visits(Analyzed at baseline, month 6 and month 12.)
- Impairment of other daily activities (number)(Analyzed at baseline, month 6 and month 12.)
研究者
Laura Carrozzi
Full Professor of Medicine
University of Pisa