Pilot Study to Investigate Response to HRV Challenge in Asthmatics
Research type
Research Study
Full title
A Pilot Study to Investigate the Safety, Tolerability and Variability of Response to Challenge with Human Rhinovirus-16 (HRV-16) in Volunteers with Asthma-like Symptoms
IRAS ID
192187
Contact name
Ganesh Balaratnam
Contact email
Sponsor organisation
hVIVO Services Limited
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
This is an open-label, exploratory pilot study to investigate the safety, tolerability and variability of response to challenge with Human Rhinovirus 16 (HRV-16) in volunteers with asthma-like symptoms. Up to 500 subjects aged 18 to 70 will be administered with HRV-16 via intranasal inoculation using a viral titre which has been proven safe in previous hVIVO viral challenge studies. The design of the study is as follows:
Visit 1: Screening visit to determine eligibility within 90 days prior to quarantine admission.
Peak expiratory flow (PEF) self-testing and completion of diary cards from Day -14 to Day 28 (± 3 days) inclusive.
- 4 x daily in quarantine
- 2 x daily at home (once on Day 28)Methacholine bronchial challenge test, if required.
Visit 2: Day -5; pre-quarantine check.
Visit 3: Day -1; Admission to the Quarantine Unit; subjects will be resident in the Quarantine Unit for approximately 10 days:
- Day 0: Intranasal inoculation with HRV-16
- Day 1 to 8 (inclusive): Clinical assessments and safety monitoring (including exacerbations, adverse events and concomitant medications)
- Day 8: Discharge from quarantine at the PI's discretion.Visit 4: Day 15 (± 1 day) follow-up visit
Visit 5: Day 28 (± 3 days) follow-up visit
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
15/LO/1900
Date of REC Opinion
13 Nov 2015
REC opinion
Unfavourable Opinion