Clinical trial NCT05050903: Early Antiviral Responses to Rhinovirus Infection in Asthma
Official title: Early Antiviral Responses to Rhinovirus Infection in Asthma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Nasal IFN-λ at 6 hours post rhinovirus infection
timeFrame: 6 hours
Secondary outcomes:
measure: Nasal IFN-α at 6 hours post rhinovirus infection
timeFrame: 6 hours
measure: Nasal IFN-λ at 3 hours post rhinovirus infection
timeFrame: 3 hours
measure: Nasal IFN-λ at 24 hours post rhinovirus
timeFrame: 24 hours
measure: Nasal IFN-α at 3 hours post rhinovirus infection
timeFrame: 3 hours
measure: Nasal IFN-α at 24 hours post rhinovirus infection
timeFrame: 24 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Respiratory Research Unit, St Mary's Hospital
state: Greater London
Study officials:
affiliation: Imperial College London
name: Sebastian Johnston
role: PRINCIPAL_INVESTIGATOR
References: