Early Antiviral Responses to Rhinovirus Infection in Asthma

NCT05050903 | Recruiting

• 1 other identifier: 21SM6879
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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

  6 hours

Secondary Outcomes (5)

• Nasal IFN-α at 6 hours post rhinovirus infection

  6 hours

• Nasal IFN-λ at 3 hours post rhinovirus infection

  3 hours

• Nasal IFN-λ at 24 hours post rhinovirus

  24 hours

• Nasal IFN-α at 3 hours post rhinovirus infection

  3 hours

• Nasal IFN-α at 24 hours post rhinovirus infection

  24 hours

Study Arms (2)

Asthma

Other: Rhinovirus infection

Healthy controls

Other: Rhinovirus infection

Interventions

Rhinovirus infection OTHER

Inoculation with rhinovirus-16

Asthma; Healthy controls

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be identified from hospital outpatient clinics, primary care, spirometry sessions/clinics, other research projects, and advertisements.

You may qualify if:

• Age 18-55 years
• Doctor diagnosis of asthma
• Previous asthma exacerbation

You may not qualify if:

• 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:
• Age 18-55 years
• As for Asthma group and in addition:
• History of asthma

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Respiratory Research Unit, St Mary's Hospital

London, Greater London, W2 1NY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sebastian Johnston

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Fellow

CONTACT

020 7594 3751; imperial.magic@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 21, 2021
• Study Start: August 11, 2022
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)