Early Antiviral Responses to Rhinovirus Infection in Asthma

Asthma Clinical Trial

Official title:

Early Antiviral Responses to Rhinovirus Infection in Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05050903
• Other study ID #: 21SM6879
• Status: Recruiting
• Start date: August 11, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: April 2024
• Source: Imperial College London
• Contact: Research Fellow
• Phone: 020 7594 3751
• Email: imperial.magic[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

For Asthma group:

Inclusion Criteria:

• Age 18-55 years

• Doctor diagnosis of asthma

• Previous asthma exacerbation

Exclusion Criteria:

• 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

• Inability to understand written or verbal information in English

For healthy control group:

Inclusion Criteria:

• Age 18-55 years

Exclusion Criteria:

As for Asthma group and in addition:

• History of asthma

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Rhinovirus infection
Inoculation with rhinovirus-16

Locations

Country	Name	City	State
United Kingdom	Imperial College Respiratory Research Unit, St Mary's Hospital	London	Greater London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal IFN-? at 6 hours post rhinovirus infection	Difference in IFN-? in nasal lining fluid 6 hours following rhinovirus infection in subjects with asthma compared to healthy controls	6 hours
Secondary	Nasal IFN-a at 6 hours post rhinovirus infection	Difference in IFN-a in nasal lining fluid 6 hours following rhinovirus infection in subjects with asthma compared to healthy controls	6 hours
Secondary	Nasal IFN-? at 3 hours post rhinovirus infection	Difference in IFN-? in nasal lining fluid 3 hours following rhinovirus infection in subjects with asthma compared to healthy controls	3 hours
Secondary	Nasal IFN-? at 24 hours post rhinovirus	Difference in IFN-? in nasal lining fluid 24 hours following rhinovirus infection in subjects with asthma compared to healthy controls	24 hours
Secondary	Nasal IFN-a at 3 hours post rhinovirus infection	Difference in IFN-a in nasal lining fluid 3 hours following rhinovirus infection in subjects with asthma compared to healthy controls	3 hours
Secondary	Nasal IFN-a at 24 hours post rhinovirus infection	Difference in IFN-a in nasal lining fluid 24 hours following rhinovirus infection in subjects with asthma compared to healthy controls	24 hours