Investigating how cold viruses affect bronchiectasis exacerbations
Human Bronchiectasis Rhinovirus Challenge to Define Immunopathogenesis of Exacerbation
This study is trying to see if cold viruses make symptoms worse for people with bronchiectasis compared to healthy individuals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06931002 on ClinicalTrials.gov |
What this trial studies
This study aims to determine whether viral infections, specifically rhinovirus, lead to exacerbations in patients with bronchiectasis. Participants will be divided into two groups: those with bronchiectasis and healthy individuals. After screening and baseline investigations, participants will be exposed to a rhinovirus and monitored over six weeks through various procedures, including blood tests and bronchoscopy, to assess immune responses and exacerbation triggers. The research seeks to enhance understanding of how viral infections impact bronchiectasis and may inform future treatment strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-65 with a confirmed diagnosis of bronchiectasis and specific severity criteria.
Not a fit: Patients with bronchiectasis secondary to conditions like cystic fibrosis or those with significant medical comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and prevention strategies for exacerbations in bronchiectasis patients.
How similar studies have performed: While there is limited research specifically on rhinovirus in bronchiectasis, studies on viral infections in respiratory diseases suggest potential for significant insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * For healthy volunteers: 1\) Age 18 to 65 years. * For bronchiectasis study subjects: 1. Confirmed diagnosis of bronchiectasis aged 18-65 years with bronchiectasis severity index score of 0-8 . 2. For Pseudomonas colonised individuals, isolation of Pseudomonas aeruginosa in two or more cultures, at least 3 months apart in a 2-year period. Exclusion Criteria: * For healthy volunteers and bronchiectasis study subjects: 1. Any medical co-morbidity impacting the study in the opinion of the medical team 2. Current smoking history within last 12 months or ex smoking history \>5 pack years 3. Pre-existing serum neutralising antibodies to RV-A16 (strain to be used for challenge) 4. Close contact with infants or elderly individuals either at home or workplace 5. Pregnancy or breastfeeding * For bronchiectasis study subjects: 1\) Individuals with bronchiectasis secondary to cystic fibrosis, primary immunodeficiency, primary ciliary dyskinesia and allergic bronchopulmonary aspergillosis 2) Individuals with other significant chronic lung disease diagnoses (eg. interstitial lung disease) which would impact the study in the opinion of the medical team 4) FEV1 \< 50% predicted 8) Recent antibiotics for exacerbations within the preceding 6 weeks and prophylactic antibiotics (azithromycin or nebulised antibiotics) within preceding 4 weeks 9) Corticosteroid use (inhaled, nasal or systemic) within preceding 4 weeks.
Where this trial is running
London
- St Mary's Hospital - Imperial Clinical Respiratory Research Unit (ICRRU) — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Anand Shah, PhD — Imperial College London
- Study coordinator: Charlotte E Carter, MBChB
- Email: cecarter@ic.ac.uk
- Phone: +447814752750
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.