A Simple Prognostic Score for Future Risk Assessment in Patients With Controlled Asthma Who Undergo a Step-down Guidelines-based Strategy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- Loss of asthma control.
研究概览
简要总结
The optimal score to predict unfavourable outcome in well-controlled asthma patients who are undergoing a step-wise down-titration of their medication is still lacking. Thus, a study is warranted to prospectively develop a prognostic system -easy to perform (suitable for use in the clinical rather the research setting)- for asthmatic patients in this clinical setting.
HYPOTHESIS: A simple score system can accurately predict clinical deterioration of asthma in well-controlled patients who are undergoing a step-wise down-titration of their medication according to international guidelines.
METHODS The investigators designed a prospective, multicenter, observational study at five centers in cities across Spain.
The patients group (N = 225) will be evaluated to produce a clinical prediction rule for loss of control. The investigators will consider the following variables in the risk factor analysis: documented history of previous bronchial obstruction (FEV1/FVC < 70%), coefficient of variation (CV) of morning peak expiratory flow (PEF), history of exacerbations, fraction of exhaled nitric oxide (FENO), Asthma control test (ACT), ACT item 3 and adherence.
The score model will be prospectively validated in an independent set of 113 patients.
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
- 否
入选标准
- •Adults (age between 18 and
- •Asthma under control during the last 3 months.
- •Treated with a combination of ICS and long-acting beta-agonist (LABA.
- •Classified as "moderate asthma" by their attending physician.
排除标准
- •Active smoking.
- •Pregnancy.
- •Treatment with oral corticosteroids, omalizumab or immunotherapy.
结局指标
主要结局
Loss of asthma control.
时间窗: 12 months
Loss of control: Either ACT score ≤ 19 or the development of exacerbation or FEV1 decrease ≥20%.
次要结局
未报告次要终点
研究者
Luis Perez de Llano
MD, PhD.
Hospital Universitario Lucus Augusti
