Viral Challenge Asthma Phenotype (VCAP) Study
Research type
Research Study
Full title
A Study to Define Asthma Phenotypes by Investigating the Clinical and Biomarker Effects, Safety and Tolerability of Human Rhinovirus-16 (HRV-16) Challenge in Asthma and Healthy Subjects
IRAS ID
201608
Contact name
John Efthimiou
Contact email
Sponsor organisation
hVIVO Services Limited
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This is an exploratory study in which healthy and asthma participants will be inoculated with 'Common Cold' (i.e. Human Rhinovirus (HRV-16)), to define asthma phenotypes by investigating the clinical & biomarker effects alongside the safety and tolerability of HRV-16 infection. The study aims to administer 400 asthma participants and 100 healthy control participants with HRV-16 virus via intranasal inoculation using a viral titre which has been proven safe in previous hVIVO virus challenge studies.
The study consists of three parts:
1a) Screening: Serosuitable participants will be invited to attend a study-specific screening visit within 90 days prior to entry to quarantine where the participants will be asked to complete an informed consent form and undergo scheduled screening assessments to determine their eligibility.
1b) Self-testing (run-in period): Participants will self-test and record their peak exploratory flow (PEF), asthma symptoms and asthma medication starting from day -14, throughout their stay in quarantine until their final scheduled follow-up visit on day 28 (±3 days).
2) Quarantine phase: Two days prior to the day of inoculation with challenge virus, participants will be admitted to quarantine where their eligibility will be reassessed. If participants remains eligible they will receive the challenge virus on day 0. Participants will be discharged from the quarantine unit on day 8, unless they are discharged early (Protocol Section 7.3.3.1), or later (Protocol Section 7.3.3.2) based on their clinical condition and the Principal Investigators assessment. Participants will undergo a range of clinical assessments and safety monitoring (exacerbations, adverse events and concomitant medications) for the entirety of their stay in quarantine.
3) Follow-up: The participants will attend a follow-up 7 (±1) days following discharge from quarantine. Their final scheduled follow-up will be held on day 28 (±3), post viral challenge. Their symptoms will be reassessed and a complete safety examination performed.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
16/NE/0083
Date of REC Opinion
29 Mar 2016
REC opinion
Favourable Opinion