A Pilot Feasibility Study of Detection of IL-11 and Other Cytokines in the Exhaled Breath Condensate (EBC) and Blood of Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- No of participant with IL-11 detected in EBC and/or blood
研究概览
简要总结
IL-11 is a receptor previously proven to be highly expressed in human lungs with idiopathic lung fibrosis, and in animal model, IL-11 receptor neutralizing antibody has been shown to prevent the process of fibrosis in bleomycin-induced lung fibrosis in rats. Separately, investigators know the expression of IL-11 can be detected in human by measuring its expression in the exhaled breath condensate (EBC) and serum. With the sera obtained, investigators will examine a whole range of other interleukins which had been implicated in mammalian lung fibrosis.
Investigators aim to measure IL-11 in a pilot of human volunteers (healthy). This is important to subsequently see if IL-11 expression is increased in patients with a range of fibrotic diseases, with the potential to be used as diagnostic tool as well and to select patients who may benefit from IL-11 neutralizing antibody to delay/ cure their lung fibrosis including patients with idiopathic pulmonary fibrosis (IPF), drug/ radiation induced fibrosis and possibly even lung fibrosis as a chronic sequelae of COVID infection. IL-11 also has been shown to be highly relevant in cardiac patients- including chronic heart failure patients. Having reference ranges for IL-11 in the blood and EBC of healthy human volunteers will also be useful in future drug trials for IL-11 antibodies for future cardiac studies.
详细描述
IL-11 has been proven to be highly expressed in lungs of patients with idiopathic pulmonary fibrosis (IPF), a type of interstitial lung disease (ILD). An IL-11 neutralizing antibody has been shown to diminish lung inflammation and fibrosis in bleomycin induced lung fibrosis in mice model. In this study, IL-11 has also been shown to be expressed in samples of human lungs with IPF. The mechanism had been shown to be linked to reduction of fibroblast proliferation and activity.
The identification of individuals with different sub-types of lung fibrosis can be based on symptoms, lung function tests, radiology or even lung biopsies. However, all these methods are rather subjective and sometimes invasive but yet inconclusive. So to identify individual patients whom IL-11 may play a role in their disease processes, investigators propose to use IL-11 in EBC as a biomarker to identify these patients.
The design of this pilot study is; prospective, single arm, non-interventional study involving invasive investigations
- Procedures/ investigations
- Blood taking (venepuncture)
- Exhaled breath condensate (EBC) collection method- this involved breathing in and out through a disposable device (akin to breathing onto cold glass to produce condensate) with an external cooler device. The R Tube starter kit is a complete disposable EBC collection kit that is FDA approved in USA. It has been used in many research clinical investigations. Investigators prefer completely disposable kits (not just mouthpiece).
Laboratory method in detection and quantification of IL-11 (ELISA)- Investigators will use the Human IL-11 Quantikine ELISA kit (#D1100, R&D Systems) to measure IL-11 concentrations in serum/ plasma, and EBC. This immunoassay has been used by Prof Cook's team for accurate quantification of IL-11 concentrations within the assay ranges of 31.2 - 2,000 pg/mL in studies, and possess a similar a detection range to that of another IL-11 ELISA kit used in a prior publication which quantified IL-11 concentrations in the serum and EBC. Each ELISA kit allows for simultaneous detection in up to 96 samples (including duplicates and standards). The assay employs the quantitative sandwich ELISA technique. Investigators may also use similar technique to examine the whole range of other interleukins which involved in lung fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Participant will be assigned a research ID which will be used for sample and data analysis.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 21-65 years old with no pre-existing medical condition
- •Not on any long term medication
排除标准
- •Previous myocardial infarction (MI), inclusive of ST-elevation MI (STEMI) and non-ST-elevation MI (NSTEMI)
- •Known coronary artery disease or known flow limiting CAD (>75% stenosis)
- •Prior cardiac surgery (including but not limited to PCI, CABG, ICD/PPM implant etc)
- •Alcohol intake >10 units per week
- •Known definite diabetes mellitus or on treatment for diabetes mellitus
- •Asthma or chronic obstructive pulmonary disease
- •Subject who is pregnant.
- •Smoker (including ex-smoker and social smoker)
- •Chronic infective disease, including tuberculosis, hepatitis B and C; and HIV
- •Prior history of cancer (excludes pre-cancerous lesions)
- •Expected life expectancy less than 1 year
- •Known documented peripheral arterial disease
- •Known autoimmune disease or genetic disease
- •Known endocrine disease on treatment
- •Psychiatric illness
- •Previous stroke
- •Inability to comply with study protocol
结局指标
主要结局
No of participant with IL-11 detected in EBC and/or blood
时间窗: 2 years
A pilot study to optimize the feasibility of detection of IL-11 in EBC and blood, and other interleukins in blood of healthy volunteers.
次要结局
未报告次要终点