Inflammatory Pathways in Viral COPD Exacerbation
Research type
Research Study
Full title
Inflammatory Pathways in Viral COPD Exacerbations: Experimental Rhinovirus Challenge
IRAS ID
219258
Contact name
O M Kon
Contact email
Sponsor organisation
Genentech Inc.
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Human viral challenge models provide potential advantages over naturally occurring infection models for the study of chronic diseases such as asthma and Chronic Obstrutive Pulmonary Disease (COPD), including safety, costs and time to completion. In principle, this model will provide unprecedented insight into virus-induced exacerbations of COPD through the comprehensive collection of various samples, during the course of an experimental rhinovirus infection in patients with COPD, combined with an in-depth analysis of biomarkers. The focus will be on inflammatory and anti-viral pathways. The relevance of this study to respiratory drug development is threefold: Firstly; it will obtain new information on biomarkers in a relevant COPD exacerbation model and allow a temporal understanding relative to viral/bacterial infection that naturally occurring infection models cannot provide. This program could potentially guide the selection of new drug targets. Secondly, this study will further provide evidence of the feasibility and relevance of experimental virus challenge models in Phase II proof of concept activity studies. The temporal relationships observed between drug target and symptom/disease readout will feed forward by informing the design of future studies for drugs in the development pipeline, and will answer important questions including what drug will most likely demonstrate activity in this model, and what is the window of therapeutic opportunity. Thirdly, it will explore a previously under-appreciated sub-class of COPD patients (allergic COPD patients or COPD patients with eosinophilia) that are poorly studied and historically have been ignored in Phase II clinical trials.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
17/EM/0191
Date of REC Opinion
3 Jul 2017
REC opinion
Further Information Favourable Opinion