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A Rhinovirus Challenge Study to Investigate Exacerbations and Immune Responses in Bronchiectasis

RecruitingNAAges 18 Years - 65 YearsAllImperial College London
NCT06931002 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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,

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📋 Eligibility rules (as published)
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.
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What it tests

  • Rhinovirus A-16 Infection
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Where

1 site
St Mary's Hospital - Imperial Clinical Respiratory Research Unit (ICRRU)
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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