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

NCT06931002 | Recruiting DMC

• 1 other identifier: 23IC8574
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis Adult; Bronchiectasis With Acute Exacerbation; Bronchiectasis With Chronic Infection With Pseudomonas Aeruginosa; Viral Infection; Rhinovirus Infection

Keywords

bronchiectasis; rhinovirus; case control study

Outcome Measures

Primary Outcomes (1)

• Lower respiratory tract symptom scores

  Participants will be asked to record their lower respiratory tract symptom scores daily at prior to and in the 42 days following viral infection with rhinovirus A-16. Participants will rate their shortness of breath, and wheeze on a scale of 0 to 4, with 0 being no symptoms at all and 4 being symptoms at rest. They will rate their cough on a scale of 0 to 3, 0 being no cough and 3 being a severe cough. They will rate their sputum quantity on a scale from 0 to 3, with 0 being no sputum and 3 being large volumes of sputum (\>100ml). They will also rate their sputum quality on a score from 0 to 3, with 0 being no sputum and 3 being purulent (green) sputum.

  From enrolment to the end of the study at 42 days post viral innoculation

Secondary Outcomes (2)

• Sputum Viral Load

  From day 1 post viral innoculation to day 42.

• Sputum Neutrophils

  From day 1 post viral inoculation to day 42.

Study Arms (1)

Rhinovirus Challenge

OTHER

All patients in the study will receive Rhinovirus A-16

Biological: Rhinovirus A-16 Infection

Interventions

Rhinovirus A-16 Infection BIOLOGICAL

All participants will be deliberately infected with Rhinovirus A-16

Rhinovirus Challenge

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For healthy volunteers:
• \) 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.

You may not qualify if:

• 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:
• \) 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.

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (1)

St Mary's Hospital - Imperial Clinical Respiratory Research Unit (ICRRU)

London, W2 1BL, United Kingdom

RECRUITING

Related Links

• Website providing information about the study

MeSH Terms

Conditions

Virus Diseases; Bronchiectasis

Condition Hierarchy (Ancestors)

Infections; Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Anand Shah, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Aran Singanayagam, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Sebastian Johnston, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte E Carter, MBChB

CONTACT

+447814752750; cecarter@ic.ac.uk

Aran Singanayagam, PhD

CONTACT

a.singanayagam@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants in the study will be challenged with Rhinovirus A16.

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: July 24, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)