Bronchiectasis AdultBARRIERNCT06931002
A Rhinovirus Challenge Study to Investigate Exacerbations and Immune Responses in Bronchiectasis
A study testing Rhinovirus A-16 Infection in people with Bronchiectasis Adult and Bronchiectasis With Acute Exacerbation, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis Adult, Bronchiectasis With Acute Exacerbation, Bronchiectasis With Chronic Infection With Pseudomonas Aeruginosa
- What is being tested?
- Rhinovirus A-16 Infection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jul 2024to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aran Singanayagam, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
St Mary's Hospital - Imperial Clinical Respiratory Research Unit (ICRRU)
London, W2 1BL
Charlotte Carter, MBChB, +447814752750, bxstudy@ic.ac.uk
Faiza Ahmed, faiza.ahmed4@nhs.net
About this study
Official title: Human Bronchiectasis Rhinovirus Challenge to Define Immunopathogenesis of Exacerbation
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.
Read the 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 bronchiectasis. This model could provide crucial insights into how viral infections trigger exacerbations (flare-ups) in bronchiectasis patients. Recent studies have found that viruses, especially rhinoviruses, are present in a significant number of bronchiectasis exacerbations. However, their exact role and the mechanisms behind increased viral susceptibility in these patients remain unclear. This model will allow us to study how factors like altered lung microbiota, might influence viral susceptibility. By enabling controlled sampling of both upper and lower airways at specific times during an infection, this study offers a opportunity to understand the complex immunological responses involved. Currently there is a poor understanding of exacerbation mechanisms in bronchiectasis and future development of treatment strategies require a suitable translational system for testing. This research could shed light on why bronchiectasis patients are more vulnerable to viral infections and potentially pave the way for new strategies to predict, prevent, or manage exacerbations.
End of Study:
- Follow-up period of 42 days.
Study Centres:
- There will be 1 study centre, ICRRU within Imperial College Healthcare NHS site at St Mary's Hospital London, United Kingdom.
Study Intervention:
- All participants will be inoculated intra-nasally with rhinovirus A-16.
Study Procedures:
- Screening period (lung function tests (FEV1, FVC and PEF), height and weight/BMI, Medical and surgical history, drug history, pregnancy test for females, Lung function tests (FEV1, FVC, PEF), blood sample, nasosorption and nasal brushing.
- Baseline visit to clinic (Blood tests including for haematology, biochemistry and coagulation), vital signs, physical examination, nasosorption, nasal brushings, spontaneous sputum collection, chest x-ray, lung function tests (FEV1, FVC, PEF and FeNO) and a stool sample.
- Baseline bronchoscopy: (Blood tests, nasosorption, nasal brushings and bronchoscopy including bronchoabsorption, bronchioalveolar lavage, bronchial brushings and bronchial biopsies)
- Viral inoculation: (Vital signs, physical examination, nasal lavage, spontaneous sputum collection and intranasal RV-A16 challenge)
- Visit Day 1: (Vital signs, physical examination, review of symptom scores, nasosorption, nasal lavage, nasal brushing, spontaneous sputum collection and lung function tests (FEV1, FVC and PEF))
- Visit Day 2: (Vital signs, physical examination, review of symptom scores, bloods, nasal lavage, spontaneous sputum collection and lung function tests (FEV1, FVC and PEF))
- Visit Day 4: (Vital signs, physical examination, review of symptom scores, nasal lavage, spontaneous sputum collection and lung function tests (FEV1, FVC and PEF))
- Visit Day 7 and Bronchoscopy: (Vital signs, physical examination, review of symptom scores, blood tests, nasosorption, nasal lavage, nasal brushings, lung function tests (FEV1, FVC, PEF and FeNO), stool sample and bronchoscopy including bronchoabsorption, bronchioalveolar lavage, bronchial brushings and bronchial biopsies)
- Visit Day 10: (Vital signs, physical examination, review of symptom scores, nasal lavage, spontaneous sputum collection and lung function tests (FEV1, FVC and PEF))
- Visit Day 14: (Vital signs, physical examination, review of symptom scores, bloods, nasosorption, nasal lavage, spontaneous sputum collection and lung function tests (FEV1, FVC and PEF))
- Visit Day 21: (Vital signs, physical examination, review of symptom scores, nasal lavage, spontaneous sputum collection and lung function tests (FEV1, FVC and PEF))
- Visit Day 28: (Vital signs, physical examination, review of symptom scores, nasal lavage, spontaneous sputum collection and lung function tests (FEV1, FVC and PEF))
- Visit Day 42: (Vital signs, physical examination, review of symptom scores, bloods, nasosorption, nasal lavage, nasal brush, spontaneous sputum collection and lung function tests (FEV1, FVC and PEF) and stool sample)
Study Sample Size:
- 18 participants will be recruited with bronchiectasis, 18 patients with bronchiectasis and chronic pseudomonas colonisation and 18 healthy participants will be recruited.
Statistical Methods:
- Using an independent two-sided t-test a sample size of 15 participants per group will allow the detection of a significant difference in lower respiratory tract symptom scores and secondary endpoints.
- Conditions
- Bronchiectasis Adult, Bronchiectasis With Acute Exacerbation, Bronchiectasis With Chronic Infection With Pseudomonas Aeruginosa, Viral Infection, Rhinovirus Infection
- Being tested
- Rhinovirus A-16 Infection
- Keywords
- bronchiectasis, rhinovirus, case control study
- Medical subject headings
- Virus Diseases, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhinovirus A-16 InfectionBiological
All participants will be deliberately infected with Rhinovirus A-16
| Study group | Role | What they receive |
|---|---|---|
| Rhinovirus Challenge | Other | All patients in the study will receive Rhinovirus A-16 Receives: Biological: Rhinovirus A-16 Infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrolment to the end of the study at 42 days post viral innoculation
Secondary outcomes (2)
Sputum Viral Load
The investigators will use qPCR to measure viral load in spontaneously expectorated sputum produced by patients at study visits.
Measured: From day 1 post viral innoculation to day 42.
Sputum Neutrophils
The investigators will use flow cytometry to measure sputum neutrophils on spontaneously expectorated sputum from day 1 to day 42.
Measured: From day 1 post viral inoculation to day 42.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start24 Jul 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants in the study will be challenged with Rhinovirus A16.
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Anand Shah, PhD, Principal investigator, Imperial College LondonAran Singanayagam, PhD, Principal investigator, Imperial College LondonSebastian Johnston, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931002
- Sponsor's protocol ID
- 23IC8574
- Acronym
- BARRIER
- Status last verified
- Jul 2025
- First submitted
- 9 Apr 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not be sharing individual participant data to protect patient confidentiality and privacy.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Bronchiectasis Rhinovirus Challenge to Define Immunopathogenesis of Exacerbation
- ClinicalTrials.gov ID
- NCT06931002
- Acronym / sponsor ID
- BARRIER / 23IC8574
- Conditions
- Bronchiectasis Adult, Bronchiectasis With Acute Exacerbation, Bronchiectasis With Chronic Infection With Pseudomonas Aeruginosa, Viral Infection, Rhinovirus Infection
- Keywords
- bronchiectasis, rhinovirus, case control study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 bronchiectasis. This model could provide crucial insights into how viral infections trigger exacerbations (flare-ups) in bronchiectasis patients. Recent studies have found that viruses, especially rhinoviruses, are present in a significant number of bronchiectasis exacerbations. However, their exact role and the mechanisms behind increased viral susceptibility in these patients remain unclear. This model will allow us to study how factors like altered lung microbiota, might influence viral susceptibility. By enabling controlled sampling of both upper and lower airways at specific times during an infection, this study offers a opportunity to understand the complex immunological responses involved. Currently there is a poor understanding of exacerbation mechanisms in bronchiectasis and future development of treatment strategies require a suitable translational system for testing. This research could shed light on why bronchiectasis patients are more vulnerable to viral infections and potentially pave the way for new strategies to predict, prevent, or manage exacerbations.
End of Study:
- Follow-up period of 42 days.
Study Centres:
- There will be 1 study centre, ICRRU within Imperial College Healthcare NHS site at St Mary's Hospital London, United Kingdom.
Study Intervention:
- All participants will be inoculated intra-nasally with rhinovirus A-16.
Study Procedures:
- Screening period (lung function tests (FEV1, FVC and PEF), height and weight/BMI, Medical and surgical history, drug history, pregnancy test for females, Lung function tests (FEV1, FVC, PEF), blood sample, nasosorption and nasal brushing.
- Baseline visit to clinic (Blood tests including for haematology, biochemistry and coagulation), vital signs, physical examination, nasosorption, nasal brushings, spontaneous sputum collection, chest x-ray, lung function tests (FEV1, FVC, PEF and FeNO) and a stool sample.
- Baseline bronchoscopy: (Blood tests, nasosorption, nasal brushings and bronchoscopy including bronchoabsorption, bronchioalveolar lavage, bronchial brushings and bronchial biopsies)
- Viral inoculation: (Vital signs, physical examination, nasal lavage, spontaneous sputum collection and intranasal RV-A16 challenge)
- Visit Day 1: (Vital signs, physical examination, review of symptom scores, nasosorption, nasal lavage, nasal brushing, spontaneous sputum collection and lung function tests (FEV1, FVC and PEF))
- Visit Day 2: (Vital signs, physical examination, review of symptom scores, bloods, nasal lavage, spontaneous sputum collection and lung function tests (FEV1, FVC and PEF))
- Visit Day 4: (Vital signs, physical examination, review of symptom scores, nasal lavage, spontaneous sputum collection and lung function tests (FEV1, FVC and PEF))
- Visit Day 7 and Bronchoscopy: (Vital signs, physical examination, review of symptom scores, blood tests, nasosorption, nasal lavage, nasal brushings, lung function tests (FEV1, FVC, PEF and FeNO), stool sample and bronchoscopy including bronchoabsorption, bronchioalveolar lavage, bronchial brushings and bronchial biopsies)
- Visit Day 10: (Vital signs, physical examination, review of symptom scores, nasal lavage, spontaneous sputum collection and lung function tests (FEV1, FVC and PEF))
- Visit Day 14: (Vital signs, physical examination, review of symptom scores, bloods, nasosorption, nasal lavage, spontaneous sputum collection and lung function tests (FEV1, FVC and PEF))
- Visit Day 21: (Vital signs, physical examination, review of symptom scores, nasal lavage, spontaneous sputum collection and lung function tests (FEV1, FVC and PEF))
- Visit Day 28: (Vital signs, physical examination, review of symptom scores, nasal lavage, spontaneous sputum collection and lung function tests (FEV1, FVC and PEF))
- Visit Day 42: (Vital signs, physical examination, review of symptom scores, bloods, nasosorption, nasal lavage, nasal brush, spontaneous sputum collection and lung function tests (FEV1, FVC and PEF) and stool sample)
Study Sample Size:
- 18 participants will be recruited with bronchiectasis, 18 patients with bronchiectasis and chronic pseudomonas colonisation and 18 healthy participants will be recruited.
Statistical Methods:
- Using an independent two-sided t-test a sample size of 15 participants per group will allow the detection of a significant difference in lower respiratory tract symptom scores and secondary endpoints.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants in the study will be challenged with Rhinovirus A16.
| Arm | Type | Receives |
|---|---|---|
| Rhinovirus Challenge | Other | Biological: Rhinovirus A-16 InfectionAll patients in the study will receive Rhinovirus A-16 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- For healthy volunteers:
- 1) Age 18 to 65 years.
- For bronchiectasis study subjects:
Key exclusion criteria (8 listed)
- For healthy volunteers and bronchiectasis study subjects:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhinovirus A-16 InfectionAll participants will be deliberately infected with Rhinovirus A-16 | Biological | Rhinovirus Challenge |
Primary outcome
Lower respiratory tract symptom scores
Time frame: From enrolment to the end of the study at 42 days post viral innoculation
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.
2 secondary outcomes
Sputum Viral Load
Time frame: From day 1 post viral innoculation to day 42.
Sputum Neutrophils
Time frame: From day 1 post viral inoculation to day 42.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Website providing information about the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. The investigators will not be sharing individual participant data to protect patient confidentiality and privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aran Singanayagam, PhD contact
Anand Shah, PhD principal investigator
Imperial College London
Aran Singanayagam, PhD principal investigator
Imperial College London
Sebastian Johnston, PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhinovirus A-16 Infection in people with Bronchiectasis Adult and Bronchiectasis With Acute Exacerbation, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte E Carter, MBChB (+447814752750, cecarter@ic.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower respiratory tract symptom scores (time frame: From enrolment to the end of the study at 42 days post viral innoculation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.