Actively Recruiting
Human Bronchiectasis Rhinovirus Challenge to Define Immunopathogenesis of Exacerbation
Led by Imperial College London · Updated on 2025-07-09
54
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
I
Imperial College London
Lead Sponsor
I
Imperial College Healthcare NHS Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand if a common cold virus, specifically Rhinovirus A-16, causes flare-ups in people with bronchiectasis, a chronic lung condition affecting many individuals. It will compare responses between bronchiectasis patients and healthy participants to explore differences in immune reactions and factors like lung microbiota that might influence infection risk. The study seeks to clarify why bronchiectasis patients may be more vulnerable to viral infections and how exacerbations develop. All participants will receive a nasal spray containing Rhinovirus A-16. Before this, they will undergo screening and baseline tests including blood work, lung function tests, and bronchoscopy. After viral exposure, they will have multiple visits over six weeks with procedures such as spirometry, nasal and sputum sampling, blood tests, and repeat bronchoscopies. Participants will keep daily symptom diaries throughout the study. Participants will have detailed assessments at screening, baseline, and several follow-up visits up to 42 days post-inoculation. Tests include lung function (FEV1, FVC, PEF, FeNO), blood sampling, nasal lavage and brushing, sputum collection, chest x-rays, and stool samples. Researchers will monitor symptom scores and immune responses to measure the impact of viral infection. The study includes 18 bronchiectasis patients with chronic Pseudomonas infection, 18 bronchiectasis patients without, and 18 healthy volunteers.
CONDITIONS
Brief Title
A Rhinovirus Challenge Study to Investigate Exacerbations and Immune Responses in Bronchiectasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For healthy volunteers: Age 18 to 65 years.
- For bronchiectasis patients: Confirmed diagnosis of bronchiectasis aged 18 to 65 years with a severity index score of 0 to 8.
- For Pseudomonas colonised individuals: Isolation of Pseudomonas aeruginosa in two or more cultures at least 3 months apart within a 2-year period.
You will not qualify if you...
- Any medical condition affecting study participation, as judged by medical staff.
- Current smoking or smoking within the last 12 months, or a history of more than 5 pack years.
- Existing neutralising antibodies to Rhinovirus A-16.
- Close contact with infants or elderly people at home or work.
- Pregnancy or breastfeeding.
- Bronchiectasis due to cystic fibrosis, primary immunodeficiency, primary ciliary dyskinesia, or allergic bronchopulmonary aspergillosis.
- Other significant chronic lung diseases affecting study participation.
- Lung function with FEV1 less than 50% predicted.
- Recent antibiotic use for exacerbations within 6 weeks or prophylactic antibiotics within 4 weeks.
- Use of corticosteroids (inhaled, nasal, or systemic) within 4 weeks.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants attend baseline visits including clinic assessments, blood tests, lung function tests, imaging, and bronchoscopy to collect samples and establish pre-infection status.
Multiple visits including 1 baseline visit and 1 baseline bronchoscopy visit
Duration - 14 days
Participants are inoculated intra-nasally with Rhinovirus A-16 and closely monitored through a series of visits to assess symptoms, collect biological samples, and perform lung function tests.
Visits on Day 0 (inoculation), Day 1, Day 2, Day 4, Day 7 (including bronchoscopy), Day 10, and Day 14
Duration - 28 days
Participants continue to be monitored for symptom progression and recovery with clinical assessments and sample collections.
Visits on Day 21, Day 28, and Day 42 with clinical assessments and sample collections
Trial Site Locations
Total: 1 location
1
St Mary's Hospital - Imperial Clinical Respiratory Research Unit (ICRRU)
London, United Kingdom, W2 1BL
Actively Recruiting
Research Team
C
Charlotte E Carter, MBChB
A
Aran Singanayagam, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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