Safety and Efficacy of Vapendavir in COPD Patients (ALT-VPV-203)
Research type
Research Study
Full title
A multi-center, randomized, double-blind, placebo-controlled clinical trial comparing the safety and efficacy of two different oral vapendavir (VPV) doses with placebo as treatment for rhinovirus (RV) in participants with chronic obstructive pulmonary disease (COPD)
IRAS ID
1013645
Contact name
Jeffrey Bruno
Contact email
Sponsor organisation
Altesa BioSciences Inc.
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the test medicine, Vapendavir, as a treatment of rhinovirus (RV) infections in patients with chronic obstructive pulmonary disease (COPD). RV are the most frequent cause of the common cold and are associated with upper respiratory tract infection (such as the nose and mouth). Many patients with COPD experience frequent acute deteriorations in respiratory function, approximately 50% of which are caused by RV infections.
This Phase 2b study will try to determine the appropriate dose of test medicine to reduce the severity and/or duration of respiratory symptoms associated with RV infections in patients with COPD. Two doses will be tested. Approximately 900 male and female participants aged 40 to 85 years will be enrolled to achieve a minimum of 180 randomised participants over an approximate 16-month study duration. Participants will be enrolled into an observational phase to establish pre-symptomatic baseline symptoms of COPD until an RV infection occurs, at which point the participant will be randomised. Participants will be re-screened every 6 months during the observational phase to review continued eligibility and will undergo a monthly phone call with the site. Participants will be required to complete questionnaires throughout the study to assess the severity of COPD.
Should an RV infection occur, participants will be randomised into three groups to receive either test medicine (one of two doses) or placebo (dummy medicine) for a total of seven doses. Participants will undergo follow-up for 42 days after the first dose.
The study will be conducted at approximately up to 8 NHS and non-NHS sites across the UK. The study will involve 6 clinical visits plus screening visit(s).
REC name
London - Surrey Borders Research Ethics Committee
REC reference
26/LO/0246
Date of REC Opinion
6 May 2026
REC opinion
Further Information Favourable Opinion