Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625944
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Exploring How Viral Infections Affect People With Chronic Lung Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Cohort Study to Understand Impact of Viral Infection in Chronic Lung Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIVILEGE
Brief Summary:
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 volunteers39 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
Detailed Description:
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
sputum
nasal samples Nasopharyngeal swab synthetic absorptive matrix SAM sampling to sample nasal lining fluid and nasal brushings
Exhaled breath
Venous 40mls and capillary blood 05mls
Stool remote stool sampling performed at home and posted in using secure bespoke collection kits
ii Exacerbation monitoring and sampling All participants will record daily diary cards which will be monitored by the study team This will enable full characterisation of all exacerbations including those that would typically be unreported in routine clinical circumstances Participants that develop symptoms of acute viral infection or acute exacerbation will have the following sampling and clinical assessment as detailed above
Early exacerbation sampling ampamplt48hrs of increased symptoms REMOTE STUDY VISIT from home
Remote nasopharyngeal swab and sputum sampling with bespoke collection kits
Remote capillary blood sampling with bespoke collection kits
Mid-exacerbation sampling within 5 days of increased symptoms IN PERSON VISIT
clinical assessment spirometry validated questionnaires as per baseline
sputum
nasal samples Nasopharyngeal swab SAM and nasal brushings
Exhaled breath
Venous 40mls and capillary blood 05mls
Stool remote stool sampling using bespoke collection kits
Exacerbation recovery sampling 4 weeks after initial increased symptoms REMOTE STUDY VISIT from home
Remote nasopharyngeal swab SAM and sputum sampling with bespoke collection kits
Remote capillary blood sampling with bespoke collection kits iii Stable longitudinal assessment All participants will undergo further clinical visits similar to baseline at 12 monthly intervals over a 2 year period as detailed above
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
sputum
nasal samples Nasopharyngeal swab synthetic absorptive matrix SAM sampling to sample nasal lining fluid and nasal brushings
Exhaled breath
Venous 40mls and capillary blood 05mls
Stool remote stool sampling performed at home and posted in using secure bespoke collection kits
ii Exacerbation monitoring and sampling All participants will record daily diary cards which will be monitored by the study team This will enable full characterisation of all exacerbations including those that would typically be unreported in routine clinical circumstances Participants that develop symptoms of acute viral infection or acute exacerbation will have the following sampling and clinical assessment as detailed above
Early exacerbation sampling ampamplt48hrs of increased symptoms REMOTE STUDY VISIT from home
Remote nasopharyngeal swab and sputum sampling with bespoke collection kits
Remote capillary blood sampling with bespoke collection kits
Mid-exacerbation sampling within 5 days of increased symptoms IN PERSON VISIT
clinical assessment spirometry validated questionnaires as per baseline
sputum
nasal samples Nasopharyngeal swab SAM and nasal brushings
Exhaled breath
Venous 40mls and capillary blood 05mls
Stool remote stool sampling using bespoke collection kits
Exacerbation recovery sampling 4 weeks after initial increased symptoms REMOTE STUDY VISIT from home
Remote nasopharyngeal swab SAM and sputum sampling with bespoke collection kits
Remote capillary blood sampling with bespoke collection kits iii Stable longitudinal assessment All participants will undergo further clinical visits similar to baseline at 12 monthly intervals over a 2 year period as detailed above
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None