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临床试验/NCT04563988
NCT04563988已完成不适用

Factors for Predicting Severe Asthma Exacerbators in Adult Asthmatics: A Real Word- Effectiveness Study

Hae-Sim Park1 个研究点 分布在 1 个国家目标入组 5,058 人开始时间: 2018年10月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5,058
试验地点
1
主要终点
Identifying prognostic factors for risk of severe asthma exacerbation

研究概览

简要总结

This study is a single-center, retrospective, cross-sectional study. It plan to investigate the predictors for asthma exacerbation in long term follow up real world management with analyzing big data of electronic medical records (EMR).

详细描述

The long-term goals of asthma treatment are to achieve well control of symptoms and to minimize the future risk of asthma exacerbations (AEs). Asthma is a heterogeneous disease with various responses to treatment and clinical outcomes. AEs are a prominent feature of severe asthmatics; however, frequent AEs have also been reported in mild asthmatics.

This is a prospectively designed observational study to identify predictors for patients with frequent AEs among adult asthmatics by analyzing medical big data of electronic medical records (EMR), which will provide an insight in the long-term management of adult asthmatics in real-world practice.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged ≥17 years
  • Patients having bronchial asthma with J45-J46 code of International classification of Diseases (10th edition on EMR)
  • Asthmatics who had been treated by allergy or respiratory specialists

排除标准

  • Patients who has less than one year for asthma treatment

结局指标

主要结局

Identifying prognostic factors for risk of severe asthma exacerbation

时间窗: During the initial 2 years

Identifying prognostic factors for risk of severe asthma exacerbation

次要结局

  • Evaluating ECP (ug/L) to predict severe asthma exacerbation(During 10 years of treatment)
  • Sensitivity and specificity of predictors(during the initial 2 years and the following 3-10 years of treatment)
  • Evaluating peripheral eosiniphil, neutrophil, basophil and lymphocyte counts to predict severe asthma exacerbation(During 10 years of treatment)
  • Evaluating total IgE (KU/L) to predict severe asthma exacerbation(During 10 years of treatment)
  • Evaluating sputum eosinophils (%) to predict severe asthma exacerbation(During 10 years of treatment)
  • Evaluating FEV1 (%) and FEV1/FVC (%) to predict severe asthma exacerbation(During 10 years of treatment)
  • Comparing clinical characteristics according to the frequency of severe asthma exacerbation(During the initial 2 years)

研究者

发起方
Hae-Sim Park
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hae-Sim Park

Principal investigator, Clinical professor, Department of Allergy and Clinical Immunology

Ajou University School of Medicine

研究点 (1)

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