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临床试验/NCT02871947
NCT02871947Unknown不适用

Epidemiology and Cytokines Analysis of Severe Asthma Patients in Taiwan

Taipei Veterans General Hospital, Taiwan2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
70
试验地点
2
主要终点
asthma acute exacerbation

研究概览

简要总结

Severe asthma is a heterogeneous disease characterized by the need for treatment with high doses of inhaled corticosteroids. It affects 5%-10% of asthmatic patients, although it accounts for a significant percentage of the consumption of health care resources. Severe asthma comprises various clinical and pathophysiological phenotypes. In this current study, we aimed to clinical characteristics and cytokes profile in severe asthma patients.

详细描述

To investigate the clinical phenotypes and inflammatory endotype by analyzing cytokines in severe asthma patients, it may improve characterization of the disease and contribute to improved selection of appropriate treatment. It could also help link genotypes with their phenotypic manifestations and their natural history and prognosis. A greater understanding of the phenotypes of severe asthma could enable identification of biomarkers for each phenotype, and identify the association between biokarkers and clinical outcomes in severe asthma 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
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Asthma which requires treatment with guidelines suggested medications for GINA steps 4-5 asthma (high dose ICS and LABA or leukotriene modifier/theophylline) for the previous year or systemic CS for 50% of the previous year to prevent it from becoming ''uncontrolled'' or which remains ''uncontrolled'' despite this therapy
  • Uncontrolled asthma defined as at least one of the following:
  • (1). Poor symptom control: ACQ consistently>1.5, ACT<20 (or ''not well controlled'' by NAEPP/GINA guidelines) (2). Frequent severe exacerbations: two or more bursts of systemic CS (>3 days each) in the previous year (3). Serious exacerbations: at least one hospitalization, ICU stay or mechanical ventilation in the previous year (4). Airflow limitation: after appropriate bronchodilator withhold FEV1<80% predicted (in the face of reduced FEV1/FVC defined as less than the lower limit of normal)

排除标准

  • (1). mild to moderate persistent asthma (2). COPD or other lung diseases (3). malignancy (4). long-term O2 therapy more than 15 hours/day (5). long-term NIPPV use (> 6 hours/day) (6). no inform consent and cannot be followed regularly (7). active TB or other infection diseases

结局指标

主要结局

asthma acute exacerbation

时间窗: 1 year follow-up

次要结局

  • inflammatory biomarkers(1, 3, 6, 9. 12 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

vghtpe user

Diahn-Warng Perng, Department of Chest Medicine

Taipei Veterans General Hospital, Taiwan

研究点 (2)

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