跳至主要内容
临床试验/NCT01565031
NCT01565031Unknown不适用

A Simple Prognostic Score for Future Risk Assessment in Patients With Controlled Asthma Who Undergo a Step-down Guidelines-based Strategy

Luis Perez de Llano1 个研究点 分布在 1 个国家目标入组 338 人开始时间: 2012年5月最近更新:
适应症

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

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

发起方
Luis Perez de Llano
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Luis Perez de Llano

MD, PhD.

Hospital Universitario Lucus Augusti

研究点 (1)

Loading locations...

相似试验