NL-OMON56716尚未招募不适用
Bronchial thermoplasty (BT) for severe asthma in the biologic era: a randomized controlled trial (BOOSTER trial) - BOOSTER trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-adult (>18 years)
- •-severe uncontrolled asthma (defined as ACQ above 1.5) despite optimal medical
- •therapy (GINA treatment step 5; alternative diseases excluded, therapy
- •compliance and adequate inhalation technique confirmed)
- •-1 or more trials of treatment with a biologic or ineligible for biologic
- •-2 or more severe asthma exacerbations in the previous year (defined as the
- •need for a course of OCS or doubling dose of maintenance OCS for at least 3
- •consecutive days)
- •-FEV1 >= 50% predicted after 400µg inhaled salbutamol or equivalent
排除标准
- •-chronic OCS therapy at a dose >20 mg/day prednisone equivalent;
- •-anti-coagulation therapy that cannot be stopped temporarily
- •-comorbidities that are a contra-indication for BT (e.g. bronchiectasis, heart
- •-pregnancy;
- •-body mass index >=35;
- •-current or ex-smokers with >20 pack years;
- •-DLCOc <70%
- •-Subject uses an internal or external pacemaker or cardiac defibrillator
研究者
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