Standardised Rhinovirus Challenge in Asthma Patients
Research type
Research Study
Full title
A Dose-Finding and Longitudinal Biomarker Study of Rhinovirus Challenge in Healthy Volunteers and Mild-Moderate Asthmatics to Evaluate the Safety and Use of a Human Rhinovirus Preparation in Developing High Dimensionality Phenotypes ("Handprints") for Asthma
IRAS ID
172645
Contact name
Dave Singh
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
2013-000618-39, European Clinical Trials Database (EudraCT) number
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
This is a two-part non randomised, multicentre trial evaluating the effect of a nasal rhinovirus challenge in healthy participants and participants with mild-moderate asthma to be conducted in conformance with Good Clinical Practices.
Part 1 of this study has been conducted outside of the UK (in the Netherlands and in Germany). The purpose of Part 1 is to determine the best dose of rhinovirus (a virus that induces a common cold) to use in Part II of the study.
Part II of the study will be conducted in the UK, The Netherlands and in Germany. The purpose of Part II is to assess the effects of a common cold in the airways of asthma patients.
Part II of this study involves causing a common cold in up to a total of 25 mild to moderate asthmatic volunteers by spraying rhinovirus into one nostril (nasal rhinovirus challenge). This will cause a safe and limited viral infection. A variety of biological chemicals will be measured before and after rhinovirus challenge at various time points and in various bodily fluids that may be relevant to the rhinovirus and/or the participant's asthma. In addition to routine safety tests, other measured outcomes will include the results of spirometry (blowing tests), breath analysis and reported symptoms.
Following an approximately 28 day screening period, volunteers will receive the rhinovirus challenge agent and then be followed for approximately 14 days after viral challenge. There will be a follow-up safety phone call approximately 24 days after the rhinovirus challenge.
This study is part of a larger set of studies conducted by U-BIOPRED consortium. (The Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes). The aim is to develop a standard method of studying asthma in volunteers while they are having a common cold and to understand how asthma attacks are caused (especially from viruses) by looking at the levels of biological chemicals during limited asthma deterioration. This is intended to help improve the development of new medicines for asthma.REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
15/NW/0487
Date of REC Opinion
13 Jul 2015
REC opinion
Further Information Favourable Opinion