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临床试验/NCT06625944
NCT06625944招募中不适用

Prospective Cohort Study to Understand Impact of Viral Infection in Chronic Lung Disease

Imperial College London1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
180
试验地点
1
主要终点
Respiratory viruses detection during exaccerbations

研究概览

简要总结

Many people with chronic lung disease have disease flare-ups. It was previously believed that these were mainly caused by bacteria but recent evidence suggests that viruses could be an important trigger. This study will recruit volunteers with chronic lung disease and take samples both when well (at baseline) and during flare-ups (exacerbations) to better understand the role of viruses in triggering exacerbations and also how the immune response is affected. The researchers will follow the volunteers' progress for up to two years. Whenever they get unwell they will take some samples (nose swabs, finger prick testing, phlegm sample) and post them to the researchers. Then, they will come in for a visit for more samples (blood tests, further swabs) and a review.

详细描述

Individuals with chronic lung disease are characterised by exacerbations (episodes of increased symptoms such as breathlessness, sputum production etc) which have been shown to be important drivers of disease severity. Viral infections are well recognised causes of asthma exacerbations but the same detail of understanding regarding the effect of viral infection on other chronic respiratory conditions such as chronic obstructive pulmonary disease (COPD) and bronchiectasis is lacking. During the COVID-19 pandemic, when isolation measures were in place for individuals with chronic respiratory disease, episodes of exacerbation were substantially decreased, suggesting a causal link between viruses and exacerbations. Such information is critical in an age with increasing concerns regarding antibiotic resistance and may change practice towards early administration of antiviral agents for respiratory disease exacerbations. To date, prospective surveillance studies in chronic lung disease have been predominantly cross sectional and focussed on hospitalised individuals where presentation is often late with reduced sensitivity for viral detection and no understanding of baseline disease state. The our study will establish closely monitored prospective patient cohort in order to assess their viral and immune status at baseline and in the early phases of an exacerbation in order to better understand the role of respiratory viruses in chronic lung disease.

Specifically, this unique study design will allow us to study the following important areas in unprecedented detail and depth: (i) Early identification and diagnosis of clinical deterioration / exacerbations to comprehensively understand the role played by viruses in chronic lung disease exacerbations. (ii) Full capture of all clinical deterioration / exacerbation events experienced by patients with chronic lung disease including mild, typically unreported episodes. (iii) Evaluation of the immune and microbiological dynamics associated with recovery from exacerbation episodes and the impact upon longer term disease progression.

Clinical Visits and Sampling:

(i) Baseline study visit: All eligible individuals will undergo screening when clinically stable including clinical history/ examination, respiratory function testing (spirometry) and a severity assessment with the use of validated questionnaires (COPD assessment test (CAT), Bronchiectasis Health Questionnaire (BHQ)). Clinical information including microbiology cultures, the underlying lung disease and other medical conditions and medication history will be obtained from medical records.

Prior imaging including CT images will be pseudoanonymised and stored for radiological scoring and analysis. At the first study visit the following biological samples will be taken to address the study objectives:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults with a physician confirmed diagnosis of chronic airway disease (e.g. COPD and bronchiectasis) according to established diagnostic criteria.
  • Prior history of exacerbation within last year (defined as requiring antibiotic and/or corticosteroids).

排除标准

  • Inability to complete daily symptom diaries and/or attend for clinical assessments.
  • Exacerbation within 4 weeks of study recruitment and/or clinical instability at the time of recruitment.
  • Pregnancy.

结局指标

主要结局

Respiratory viruses detection during exaccerbations

时间窗: All exacerbations within a 24 month follow up period.

The percentage of chronic airway disease exacerbations where a respiratory virus is detected (with sub-classification of the specific viral subtypes).

次要结局

  • Differences in symptoms between viral and non-viral exacerbations(All exacerbations within a 24 month follow up period.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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