NL-OMON56494尚未招募不适用
Early detection of the effectiveness of treatment with biologicals in patients with severe asthma using fluctuation analysis of biomarkers - FABLE (Fluctuation analysis in asthma and biologics use)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Severe asthma based on the definition by the 2022 GINA guidelines.
- •Will start treatment with a biological
- •18-60 years old
- •Subject should be willing and able to perform the lung function tests and
- •other study-related procedures and comply with study protocol requirements.
- •Apart from their asthma, subjects should be generally healthy with no history
- •of a clinically relevant medical condition that in the opinion of the
- •investigator might interfere with successful study conduct and no clinically
- •relevant abnormalities on medical history.
- •Subjects should provide a signed and dated informed consent
排除标准
- •Has been tested positively for COVID-19 in the past month or has not fully
- •recovered from an earlier COVID-19 infection (e.g. post-covid syndrome) • Has
- •been treated with oral corticosteroids as high-dose therapy in the 6 weeks
- •before visit 1. • Has been treated with another biologic within 3 months before
- •start treatment with new biological (e.g. 2 months before the start of the
- •study participation) • Not able to perform spirometry/IOS/FeNO tests correctly
- •Not able to handle Respicorder well • Subject is a current smoker/vaper, uses
- •recreational drugs, or has >10 packyears • Subject is anticipated not to comply
- •with study protocol or other aspects of the study (at the discretion of the
- •investigator) • Participation to the study is not medically responsible
- •according to the study physician and/or principle investigator • Inability to
- •read and/or understand the Dutch language
研究者
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