Investigating the Role of ATP Production by Airway Epithelium in Patients With Refractory and Unexplained Chronic Cough (RCC/UCC).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Difference in expressed genes
研究概览
简要总结
Chronic cough is a common troublesome symptom which has a global prevalence of approximately 10%, but with wide variations across continents. Patients with refractory and unexplained chronic cough (RCC/UCC) often exhibit dysregulated vagal pathways, necessitating a neuronal biomarker for targeted treatment. ATP, involved in the ATP/P2X3 pathway, may serve as a potential biomarker due to its role in the cough reflex. The study aims to discover if ATP production by the airway epithelium is greater in RCC/UCC patients compared with healthy controls, if the epithelium is a source of ATP, whether gene and protein expression related to ATP production differs between these groups and whether ATP release is triggered by mechanical and chemical stimulation. Additionally, the study seeks to determine if biomarker gene expression signatures can differentiate RCC/UCC patients from healthy controls.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Participants who are currently established on treatment and their chronic cough is well controlled.
- •Unable to perform acceptable and reproducible spirometry.
- •Participants with a positive covid-19 test within 2 weeks of screening.
- •Current smoker or ex-smoker with ≥20 pack year smoking history and abstinence of ≤6 months
- •Symptoms of upper respiratory tract infection in the last 1 month which have not resolved
- •Lower respiratory tract infection or pneumonia in the last 1 month
- •Asthma exacerbation in the previous month requiring an increase or start of an inhaled corticosteroid (ICS) or oral corticosteroid (OCS)
- •Significant other primary pulmonary disorders in particular; pulmonary embolism, pulmonary hypertension, lung cancer, cystic fibrosis, significant radiologically proven emphysema, interstitial lung disease or bronchiectasis.
- •History of psychiatric illness, drug or alcohol abuse which may interfere in the participation of the trial.
- •Allergy or intolerance to sedation medication including fentanyl and midazolam, or a history of complications during procedural sedation
- •Severe coagulopathy, bleeding disorder, or medical need for anti- coagulation that would increase the risk of endobronchial biopsy as determined by the investigator
结局指标
主要结局
Difference in expressed genes
时间窗: At baseline
Expression of genes involved in intracellular ATP production, transport, extracellular metabolism in the airway epithelium will be compared in both RCC/UCC and healthy controls.
次要结局
- Difference Immune Cells and Cytokines(12 months)
- Gene Expression(At baseline)
- Difference in Nerve Morphology(baseline)
- Difference in ATP release(5,15,30 minutes)