ISRCTN45524058进行中（未招募）未知
A study of bronchoscopic biomarkers in respiratory immunology
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
- 性别
- All
入选标准
- •1. Capacity to provide written consent before any study procedures are performed and can understand and comply with the requirements of the study.
- •2. Males and non-pregnant females
- •3. Aged 18-85 years
- •4. Fluent in English, able to understand the procedures and convey any adverse events effectively to the research team
排除标准
- •Any of the following will exclude participants from the study:
- •1. Uncontrolled medical or surgical conditions that may preclude nasal or oral intubation with a bronchoscope or the bronchoscopy itself, in the opinion of the investigator
- •2. Any report of acute illness or febrile event that has not resolved 72 hours before bronchoscopy
- •3. Previous adverse reactions to benzodiazepines or anaesthetic agents (lidocaine) including reversal agents such as flumazenil
- •4. Participated (taken investigative drug and/or device) in another clinical trial within 1 month or within drug’s 5 half-lives, whichever is longer, before the study procedure (this is not relevant to participants in an EHPC study)
- •5. Full blood count, clotting or renal function level outside of normal range and deemed as clinically significant by the investigator
- •6. Very poor venous access
- •7. Not abstained from alcoholic beverages or alcohol-containing products for at least 24 hours before bronchoscopy
- •8. Receipt of blood products within 2 months prior to screening
- •9. Should not participate in this study for their own safety in the opinion of the Investigator (or designee)
- •Exclusion criteria for participants with acute or chronic respiratory disease such as asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, bronchiectasis, pneumonia or lower respiratory tract infection:
- •1. Unable to perform spirometry (spirometry must be within 6 months prior to screening)
- •2. On long term oxygen therapy (LTOT)
- •3. Oxygen saturations on screening of <92% on air
- •4. Any uncontrolled medical or surgical condition as deemed clinically significant by the CI
研究者
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