Status:
RECRUITING
A Rhinovirus Challenge Study to Investigate Exacerbations and Immune Responses in Bronchiectasis
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Imperial College Healthcare NHS Trust
Conditions:
Bronchiectasis Adult
Bronchiectasis With Acute Exacerbation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The goal of this study is to determine if viral infection with the common cold leads to an exacerbation in participants with bronchiectasis. The investigators will compare the participants with bronch...
Detailed Description
Study Rationale: Bronchiectasis is a chronic respiratory disease affective \>200,000 individuals in the UK. The investigators are aiming to develop an experimental rhinovirus challenge model for bron...
Eligibility Criteria
Inclusion
- For healthy volunteers:
- 1\) Age 18 to 65 years.
- For bronchiectasis study subjects:
- Confirmed diagnosis of bronchiectasis aged 18-65 years with bronchiectasis severity index score of 0-8 .
- For Pseudomonas colonised individuals, isolation of Pseudomonas aeruginosa in two or more cultures, at least 3 months apart in a 2-year period.
Exclusion
- For healthy volunteers and bronchiectasis study subjects:
- Any medical co-morbidity impacting the study in the opinion of the medical team
- Current smoking history within last 12 months or ex smoking history \>5 pack years
- Pre-existing serum neutralising antibodies to RV-A16 (strain to be used for challenge)
- Close contact with infants or elderly individuals either at home or workplace
- 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.
Key Trial Info
Start Date :
July 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2027
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06931002
Start Date
July 24 2024
End Date
October 30 2027
Last Update
July 9 2025
Active Locations (1)
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1
St Mary's Hospital - Imperial Clinical Respiratory Research Unit (ICRRU)
London, United Kingdom, W2 1BL