Nasal, Tracheal and Bronchial Mucosal Lining Fluid(MLF) Sampling From Patients With Respiratory Diseases
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Measurement of levels of inflammation, coagulation, complement activation and fibrosis in MLF
研究概览
简要总结
Nasal, tracheal and bronchial sampling of MLF in patients with idiopathic pulmonary fibrosis(IPF), sarcoidosis, tuberculosis(TB), asthma and COPD. Similar sampling from healthy controls for comparative data.
Aim: To characterise the molecular basis of the upper and lower airway mucosa inflammatory response in different respiratory diseases. To assess molecular biomarkers and signatures to see if these can aid diagnosis, stratification of these respiratory diseases. To direct personalised medicine and rationalise therapy.
Outcome measures:Measurement of levels of inflammation, coagulation, complement activation and fibrosis in MLF, transcriptomics from nasal curettage and airway brushings and to assess the tolerability of absorption procedures in these patients.
详细描述
Aim- To define the diagnosis, stratification and monitoring of IPF, sarcoidosis and TB, providing targets and biomarkers for new therapy. The investigators will study asthma and COPD patients with inflammation of the airways, and to compare with healthy control subjects. Characterising inflammation using upper airway sampling may eventually remove the requirement for invasive diagnostic bronchoscopy in these patients. The investigators shall assess the presence of cytokines, chemokines, together with complement, coagulation and fibrosis. The investigators propose to obtain opportunistic nasal, bronchial and tracheal mucosal samples from patients with IPF, sarcoidosis and TB. The investigators will compare these samples with healthy controls and with patients with asthma and COPD.
Objectives: Determining biomarkers and molecular signatures in terms of cytokines and chemokines, coagulation, complement activation and fibrosis in the MLF from the range of lung diseases Study design: This is a pilot study and the investigators shall obtain our study group from patients attending the bronchoscopy suite, specialist respiratory clinics and those being admitted to the wards at St Mary's Hospital under the Respiratory team. The investigators shall recruit patients with asthma and COPD,as well as age/ sex- matched healthy volunteers.
IPF, sarcoid and TB patients are usually undergoing bronchoscopy or endobronchial ultrasound(EBUS) and transbronchial needle aspiration(TBNA) for diagnostic purposes. Their diagnosis may only be confirmed after sampling is done after the bronchoscopy.
The patients included in the study will represent the following groups:
IPF at least 12 subjects Sarcoidosis at least 12 subjects TB at least 12 subjects COPD at least 12 subjects Asthma at least 12 subjects Healthy at least 12 subjects Study visits: Having identified patients suitable for this study, the study involves a single bronchoscopy, during which all airway sampling takes place. The investigators will recruit patients with asthma, COPD and healthy volunteers and they will be reimbursed for their participation, since bronchoscopy is not routinely part of their normal clinical care. They will be recruited by advertisements to the general public. They will be given relevant participant information sheet regarding this study by email or post.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer- no history of lung disease, age 18-65, BMI 18-39, PEF >90%, no reversibility, no atopy, non smoker/ ex smoker with >10PYH.
- •Asthma- diagnosis of asthma, age 18-65, BMI 18-39, GINA mild, PEF >70%, reversibility with salbutamol or positive with histamine, well controlled on asthma questionnaire(ACQ <0.75), non smoker/ex smoker with <10PYH.
- •IPF- HRCT suggestive ofILD/IPF, age 45-80, BMI 18-39, FVC >50%, DLCO 30-90%.
- •Sarcoidosis- HRCT suggestive of sarcoidosis, age 18-95, BMI 18-39, FVC>50%, DLC0>30%.
- •TB- same as sarcoidosis, including clinical history and/ or CT evidence of TB, age 18-
- •COPD- diagnosis of COPD, age 45-65, age 18-39, gold stage 2, post bronchodilator FEV1 50-79%, FEV1/FVC ratio <70%,TLCO 60-80% or emphysema on HRCT,Smoker/ex smoker with >10PYH.
排除标准
- •Healthy volunteer- use of anti-inflammatory meds including statins, antihistamines, NSAIDs, salicylates, anti-rheumatics, use of any OTC medications, URTI within the last six weeks, chronic inflammatory illness or CVS/ Resp disease/ systemic disease.
- •Asthma- Use of inhaled corticosteroids in the last 4 weeks, use of oral steroids in the last 6 months, use of anti- inflammatory meds including statins, antihistamines, NSAIDs, salicylates, anti-rheumatics, use of any OTC medications, exacerbation requiring hospitalisation the last year, URTI within the last six months, significant CVS or inflammatory disease.
- •IPF- Use of anti- inflammatory meds including statins, antihistamines, NSAIDs, salicylates, anti-rheumatics, use of oral steroids for 6 months, use of anti-fibrotic therapy( pirfendidone, nintedanib) for 6 months, FVC < 50%, baseline spO2 < 90%, use of any OTC medications, URTI within the last 6 weeks, significant CVS disease.
- •Sarcoidosis- Same as IPF, including use of methotrexate for 6 months.
- •COPD- Same as asthma volunteers and includes atopy.
- •TB- Same as IPF, including use of anti-TB drugs.
结局指标
主要结局
Measurement of levels of inflammation, coagulation, complement activation and fibrosis in MLF
时间窗: 3 years
Determining biomarkers and molecular signatures(combination of mediators) in terms of cytokines and chemokines, coagulation, complement activation and fibrosis in the MLF from a range of lung diseases. The panel of mediators we aim to measure are as follows: Type 2 inflammation, IL-1 family and vascular injury
次要结局
- Transcriptomics on upper and lower airway cell samples(3 years)