Asthma Viral Challenge study
Research type
Research Study
Full title
A Randomised Double-Blind Study of the Safety and Tolerability of Asthmatics to Challenge with Human Rhinovirus (HRV-16 [RVL])
IRAS ID
145747
Contact name
Ganesh Balaratnam
Contact email
Sponsor organisation
Retroscreen Virology Ltd
Research summary
This is a randomised double-blind, placebo-controlled study in up to 21 asthmatics, aged 18 – 55, who have been treated with short-acting inhaled β-agonists alone, in the one month prior to screening. The trial is randomised 2:1, HRV-16 (RVL) to Placebo.
Visit 1 Pre-screening
Volunteers will attend a pre-screen between Day -180 and Day -61 (prior to Challenge on Day 0). They will be informed about the aims, procedures, benefits and possible risks of the study, before informed consent and subsequent blood samples are collected.Visit 2 Screening
Serosusceptible volunteers will be invited to attend a study-specific screening visit up to 60, and no less than 15, days before Day 0. During these screening visits complete informed consent will be obtained and the volunteer will undergo scheduled assessments to determine their eligibility for the study.Self-testing
Subjects will self-test their PEF twice daily starting from Day -14 and continuing until the final scheduled follow-up visit on Day 28 (± 3 days). This self-testing will continue at screening, and also throughout a subject’s stay in quarantine.Visit 3 Pre-quarantine
Subjects will attend for a pre-quarantine screening visit on Day -5 to confirm eligibility for the quarantine phase of the study.Visit 4 Quarantine
One day prior to the day of Challenge, subjects will be admitted to quarantine, where eligibility criteria will be reviewed. If the subject remains eligible, he/she will be randomised and receive either the Viral Challenge or the Placebo Challenge inoculum on Day 0. Subjects will remain in quarantine until Day 8; however, may be asked to stay in the unit for longer than this if they remain symptomatic.Visit 5 & 6 Follow-up
Following discharge from quarantine, volunteers will attend two follow-up appointments at approximately Day 15 and Day 28. Symptoms will be assessed and a complete safety examination performed.REC name
London - City & East Research Ethics Committee
REC reference
14/LO/0485
Date of REC Opinion
16 May 2014
REC opinion
Further Information Favourable Opinion