A Rhinovirus Challenge Study to Investigate Exacerbations and Immune Responses in Bronchiectasis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorImperial College London

About this trial

The goal of this study is to determine if viral infection with the common cold leads to an exacerbation in participants with bronchiectasis. The investigators will compare the participants with bronchiectasis to a group of healthy participants. The main questions it aims to answer are:

* Does viral infection with the common cold lead to an exacerbation in bronchiectasis? * Does the immune response differ to that of a healthy participant?

Participants will attend for a screening visit to see if they are eligible. All participants who are eligible and have consented to take part will have baseline investigations done including blood tests and a bronchoscopy. They will be given a spray of a virus that causes the common cold into their nose. They will then be followed up over the next 6 weeks with some of the following procedures at each study visit; spirometry, nasosorption, nasal lavage, nasal brushing, blood test, sputum collection and a bronchoscopy. Participants will be asked to keep a daily record of their symptoms throughout the study.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Confirmed diagnosis of bronchiectasis aged 18-65 years with bronchiectasis severity index score of 0-8 .

For Pseudomonas colonised individuals, isolation of Pseudomonas aeruginosa in two or more cultures, at least 3 months apart in a 2-year period.

Disqualifiers

Any medical co-morbidity impacting the study in the opinion of the medical team

Current smoking history within last 12 months or ex smoking history >5 pack years

Pre-existing serum neutralising antibodies to RV-A16 (strain to be used for challenge)

Close contact with infants or elderly individuals either at home or workplace

Trial design

Design model

Single group

Treatments tested in this trial

  • Rhinovirus A-16 Infection

    Biological/Vaccine

    All participants will be deliberately infected with Rhinovirus A-16

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: Rhinovirus ChallengeOther 1 intervention

Trial outcomes

Primary outcomes

1

Lower respiratory tract symptom scores

Participants will be asked to record their lower respiratory tract symptom scores daily at prior to and in the 42 days following viral infection with rhinovirus A-16. Participants will rate their shortness of breath, and wheeze on a scale of 0 to 4, with 0 being no symptoms at all and 4 being symptoms at rest. They will rate their cough on a scale of 0 to 3, 0 being no cough and 3 being a severe cough. They will rate their sputum quantity on a scale from 0 to 3, with 0 being no sputum and 3 being large volumes of sputum (\>100ml). They will also rate their sputum quality on a score from 0 to 3, with 0 being no sputum and 3 being purulent (green) sputum.

Time frame
From enrolment to the end of the study at 42 days post viral innoculation

Secondary outcomes

1

Sputum Viral Load

The investigators will use qPCR to measure viral load in spontaneously expectorated sputum produced by patients at study visits.

Time frame
From day 1 post viral innoculation to day 42.
2

Sputum Neutrophils

The investigators will use flow cytometry to measure sputum neutrophils on spontaneously expectorated sputum from day 1 to day 42.

Time frame
From day 1 post viral inoculation to day 42.

Other outcomes

Sponsors and contacts

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Imperial College London

Lead sponsor

Imperial College Healthcare NHS Trust

Collaborator