Early Antiviral Responses to Rhinovirus Infection in Asthma

NCT ID: NCT05050903

Last Updated: 2024-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-11

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Asthma

Rhinovirus infection

Intervention Type OTHER

Inoculation with rhinovirus-16

Healthy controls

Rhinovirus infection

Intervention Type OTHER

Inoculation with rhinovirus-16

Interventions

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Rhinovirus infection

Inoculation with rhinovirus-16

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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


• Age 18-55 years

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:


As for Asthma group and in addition:

• History of asthma
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sebastian Johnston

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Imperial College Respiratory Research Unit, St Mary's Hospital

London, Greater London, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Research Fellow

Role: CONTACT

020 7594 3751

Facility Contacts

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Research Fellow

Role: primary

020 7594 3751

Other Identifiers

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21SM6879

Identifier Type: -

Identifier Source: org_study_id

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