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临床试验/ACTRN12617001275358
ACTRN12617001275358已完成未知

Can functional lung ventilation imaging identify treatable traits in obstructive airway disease?

Vanessa McDonald0 个研究点目标入组 100 人开始时间: 2017年9月5日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Adults (greater than or equal to 18 years) with severe treatment refractory asthma defined according to ATS/ERS criteria:
  • -Asthma which requires treatment with guidelines-suggested medications for GINA steps 4-5 (high dose ICS and LABA or leukotriene modifier/theophylline) for the previous year or systemic corticosteroids for greater than or equal to 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:
  • *Poor symptom control: ACQ consistently > 1.5, ACT < 20
  • *Frequent severe exacerbations: 2 or more bursts of systemic corticosteroids (greater than 3 days each) in the previous year
  • *Serious exacerbations: at least one hospitalisation, ICU stay or mechanical ventilation in the previous year
  • *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)
  • Adults (greater than or equal to 18 years) with obstructive airways disease (either asthma or COPD) who are to be treated with add on therapies (macrolides, monoclonal antibody therapies or itraconazole). This includes moderate or severe asthma or COPD, with persistent symptoms, and/or frequent exacerbations. Exacerbations will be defined as indicated below.

排除标准

  • Inability to attend study visits.
  • Current lung cancer or other blood, lymphatic or solid organ malignancy
  • Diagnosis with primary respiratory disease other than asthma or COPD (e.g. active tuberculosis, pulmonary fibrosis)
  • Expected prognosis poor <3 months survival
  • Pregnancy or breast-feeding

研究者

发起方
Vanessa McDonald

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