Anti-viral activity of Vapendavir in COPD subjects following rhinovirus challenge.
Research type
Research Study
Full title
A double-blind, randomized, placebo-controlled trial in participants with chronic obstructive pulmonary disease (COPD) to evaluate the impact of vapendavir on the development of lower respiratory tract symptoms following rhinovirus challenge.
IRAS ID
1007135
Contact name
Onn Kon
Contact email
Sponsor organisation
Altesa BioSciences, Inc
Clinicaltrials.gov Identifier
NCT06149494.
Research summary
This study will assess the efficacy of oral twice daily Vapendavir, an anti-viral drug in treating the symptoms associated with exacerbations of chronic obstructive pulmonary disease (COPD). COPD exacerbations account for the majority of morbidity and mortality associated with COPD, are caused predominantly by respiratory viral infections, notably rhinoviruses (RVs) of which they are no available anti-viral treatments and very little in the way of preventative vaccines. Evidence suggests that preventing the severity of viral infections by use of anti-virals early in the infection cycle will prevent the symptoms associated with COPD exacerbations, thus preventing the decrease in lung function and hence improve clinical outcomes. This study aims to test the efficacy of the anti-rhinovirus drug vapendavir in a model of rhinovirus challenge in GOLD stage II COPD subjects. Subjects will be screened to meet the inclusion and exclusion criteria of the study and if they have antibodies to the test virus (sero-positive) which will make them uninfectable. COPD subjects that are sero-negative only will be invited to enrol in the study. The study will last 10 weeks and involve 16 clinical visits. Early on during infection, once symptoms develop (before day 4) subjects will be randomised to receive either oral vapendavir or placebo. Treatment will be for 7 days only. During clinical study visits, the following samples will be taken, nasal lavage or wash to measure virus load, nasal secretions to measure inflammatory mediators, sputum, to measure virus load, inflammatory mediators and bacterial load and serum/plasma to measure antibodies to the test rhinovirus and mediators. All samples will be used for study specific purposes. Daily clinical symptom scores, and lung function will be measured during clinical visits to assess if vapendavir improves clinical symptoms and lung function thus providing evidence that an anti-viral drug can improve outcomes of COPD exacerbations.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
23/SC/0175
Date of REC Opinion
20 Sep 2023
REC opinion
Further Information Favourable Opinion