NCT06931002 A Rhinovirus Challenge Study to Investigate Exacerbations and Immune Responses in Bronchiectasis
| NCT ID | NCT06931002 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Bronchiectasis Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2024-07-24 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2024-07-24 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 bronchiectasis to a group of healthy participants. The main questions it aims to answer are: * Does viral infection with the common cold lead to an exacerbation in bronchiectasis? * Does the immune response differ to that of a healthy participant? Participants will attend for a screening visit to see if they are eligible. All participants who are eligible and have consented to take part will have baseline investigations done including blood tests and a bronchoscopy. They will be given a spray of a virus that causes the common cold into their nose. They will then be followed up over the next 6 weeks with some of the following procedures at each study visit; spirometry, nasosorption, nasal lavage, nasal brushing, blood test, sputum collection and a bronchoscopy. Participants will be asked to keep a daily record of their symptoms throughout the study.
Eligibility 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.
Contact & Investigator
Anand Shah, PhD
PRINCIPAL INVESTIGATOR
Imperial College London
Frequently Asked Questions
Who can join the NCT06931002 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Bronchiectasis Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06931002 currently recruiting?
Yes, NCT06931002 is actively recruiting participants. Contact the research team at cecarter@ic.ac.uk for enrollment information.
Where is the NCT06931002 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT06931002 clinical trial?
NCT06931002 is sponsored by Imperial College London. The principal investigator is Anand Shah, PhD at Imperial College London. The trial plans to enroll 54 participants.