AsthmaNCT05050903
Early Antiviral Responses to Rhinovirus Infection in Asthma
An observational study of Asthma, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The bulk of the morbidity and mortality related to asthma is during periods of acutely increased symptomatology called 'exacerbations'. Roughly half of asthma sufferers experience such an exacerbation each year. Most of these events are triggered by viral infections, usually the common cold virus (rhinovirus). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Rhinovirus infection
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Aug 2022to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Potential participants will be identified from hospital outpatient clinics, primary care, spirometry sessions/clinics, other research projects, and advertisements.
Who may be able to join
- Age 18-55 years
- Doctor diagnosis of asthma
- Previous asthma exacerbation
- Age 18-55 years
Who cannot join
- Smoking history over past 12 months
- Sinonasal disease, including current symptoms of allergic rhinitis
- Asthma exacerbation or an upper respiratory viral infection within the previous six weeks
- Current or concomitant use of oral steroids, monoclonal antibodies or nasal sprays
- Neutralising antibodies to rhinovirus (RV)-16
- Clinically significant diseases other than asthma which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, influence the results of the study, an/or the patient's ability to take part in it
Show all 10Show fewer
- Inability to understand written or verbal information in English
- For healthy control group:
- As for Asthma group and in addition:
- History of asthma
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Respiratory Research Unit, St Mary's Hospital
London, Greater London, W2 1NY
Research Fellow, 020 7594 3751, imperial.magic@nhs.net
About this study
The bulk of the morbidity and mortality related to asthma is during periods of acutely increased symptomatology called 'exacerbations'. Roughly half of asthma sufferers experience such an exacerbation each year. Most of these events are triggered by viral infections, usually the common cold virus (rhinovirus).
A key part of the body's defence against viral infections is to produce antiviral proteins called 'interferons', which have a myriad of effects to stop viruses. Previous work on cells taken from volunteers with asthma and healthy controls and infected with rhinovirus in the lab suggests interferon production is impaired in asthma. However when human volunteers with asthma are infected with rhinovirus, high levels of interferon are found a few days later - along with high numbers of virus. Whether the high virus numbers are the result of an initially weak interferon response, with subsequently unchecked viral replication leading to exaggerated interferon levels, is unknown as no one has measured interferons early in infection.
By infecting volunteers with asthma and healthy controls with rhinovirus at a known time, only done in a handful of centres worldwide, we will be able to measure interferons within hours of infection and well before symptoms develop.
- Conditions
- Asthma
- Being tested
- Rhinovirus infection
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhinovirus infectionOther
Inoculation with rhinovirus-16
| Study group | Role | What they receive |
|---|---|---|
| Asthma | Not described Receives: Other: Rhinovirus infection | |
| Healthy controls | Not described Receives: Other: Rhinovirus infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal IFN-λ at 6 hours post rhinovirus infection
Difference in IFN-λ in nasal lining fluid 6 hours following rhinovirus infection in subjects with asthma compared to healthy controls
Measured: 6 hours
Secondary outcomes (5)
Nasal IFN-α at 6 hours post rhinovirus infection
Difference in IFN-α in nasal lining fluid 6 hours following rhinovirus infection in subjects with asthma compared to healthy controls
Measured: 6 hours
Nasal IFN-λ at 3 hours post rhinovirus infection
Difference in IFN-λ in nasal lining fluid 3 hours following rhinovirus infection in subjects with asthma compared to healthy controls
Measured: 3 hours
Nasal IFN-λ at 24 hours post rhinovirus
Difference in IFN-λ in nasal lining fluid 24 hours following rhinovirus infection in subjects with asthma compared to healthy controls
Measured: 24 hours
Nasal IFN-α at 3 hours post rhinovirus infection
Difference in IFN-α in nasal lining fluid 3 hours following rhinovirus infection in subjects with asthma compared to healthy controls
Measured: 3 hours
Nasal IFN-α at 24 hours post rhinovirus infection
Difference in IFN-α in nasal lining fluid 24 hours following rhinovirus infection in subjects with asthma compared to healthy controls
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start11 Aug 2022
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastian Johnston, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050903
- Sponsor's protocol ID
- 21SM6879
- Status last verified
- Apr 2024
- First submitted
- 10 Sep 2021
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Antiviral Responses to Rhinovirus Infection in Asthma
- ClinicalTrials.gov ID
- NCT05050903
- Acronym / sponsor ID
- 21SM6879
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 21 Sep 2021 (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 bulk of the morbidity and mortality related to asthma is during periods of acutely increased symptomatology called 'exacerbations'. Roughly half of asthma sufferers experience such an exacerbation each year. Most of these events are triggered by viral infections, usually the common cold virus (rhinovirus).
A key part of the body's defence against viral infections is to produce antiviral proteins called 'interferons', which have a myriad of effects to stop viruses. Previous work on cells taken from volunteers with asthma and healthy controls and infected with rhinovirus in the lab suggests interferon production is impaired in asthma. However when human volunteers with asthma are infected with rhinovirus, high levels of interferon are found a few days later - along with high numbers of virus. Whether the high virus numbers are the result of an initially weak interferon response, with subsequently unchecked viral replication leading to exaggerated interferon levels, is unknown as no one has measured interferons early in infection.
By infecting volunteers with asthma and healthy controls with rhinovirus at a known time, only done in a handful of centres worldwide, we will be able to measure interferons within hours of infection and well before symptoms develop.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | Other: Rhinovirus infection |
| Healthy controls | – | Other: Rhinovirus infection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Potential participants will be identified from hospital outpatient clinics, primary care, spirometry sessions/clinics, other research projects, and advertisements.
Key inclusion criteria (4 listed)
- Age 18-55 years
- Doctor diagnosis of asthma
- Previous asthma exacerbation
- Age 18-55 years
Key exclusion criteria (10 listed)
- Smoking history over past 12 months
- Sinonasal disease, including current symptoms of allergic rhinitis
- Asthma exacerbation or an upper respiratory viral infection within the previous six weeks
- Current or concomitant use of oral steroids, monoclonal antibodies or nasal sprays
- Neutralising antibodies to rhinovirus (RV)-16
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 infectionInoculation with rhinovirus-16 | Other | Asthma, Healthy controls |
Primary outcome
Nasal IFN-λ at 6 hours post rhinovirus infection
Time frame: 6 hours
Difference in IFN-λ in nasal lining fluid 6 hours following rhinovirus infection in subjects with asthma compared to healthy controls
5 secondary outcomes
Nasal IFN-α at 6 hours post rhinovirus infection
Time frame: 6 hours
Nasal IFN-λ at 3 hours post rhinovirus infection
Time frame: 3 hours
Nasal IFN-λ at 24 hours post rhinovirus
Time frame: 24 hours
Nasal IFN-α at 3 hours post rhinovirus infection
Time frame: 3 hours
Nasal IFN-α at 24 hours post rhinovirus infection
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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. This study is not recruiting at the moment.
Sebastian Johnston 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?
An observational study of Asthma, 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 24 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Research Fellow (020 7594 3751, imperial.magic@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal IFN-λ at 6 hours post rhinovirus infection (time frame: 6 hours). 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 24 Apr 2024.