Efficacy and safety of GSK3923868 during experimental HRV-16 infection in mild asthma participants
Research type
Research Study
Full title
A Randomised, Double-blind, Placebo Controlled, Repeat Dose Phase 1b Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled GSK3923868 During Experimental Human Rhinovirus Infection in Participants with Mild Asthma.
IRAS ID
1005333
Contact name
Amanda Foster
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2021-006640-27
ISRCTN Number
ISRCTN15115094
Research summary
GlaxoSmithKline (GSK) is developing a new drug (GSK3923868) for the treatment of human rhinovirus (HRV), the most common cause of the common cold. The symptoms following HRV infection are generally limited to runny nose, sore throat and sneezing (i.e. the upper respiratory tract). However, in patients with long term lung conditions such as chronic obstructive pulmonary disease (COPD) and asthma, HRV infection can lead to sudden worsening of disease symptoms (exacerbations) through infection of the lung itself. Exacerbations can result in serious illness that can cause hospitalisation or even death.
Currently there are no available treatments or vaccines for HRV, other than medicines that help to treat cold symptoms. Our study drug works by disrupting the process the virus uses to reproduce itself, which may help improve the immune system’s ability to fight off lung infections. If the study drug works, it will provide a good treatment option for patients with COPD and asthma to prevent exacerbations.
This study has two parts, Parts A and B. The main aim of this study is to assess how well the study drug reduces lung symptoms in participants with asthma.
Part A Cohort 1 will assess how well the study drug works at preventing lung symptoms after experimental HRV infection (i.e. therapeutic treatment). If the study drug works well in this setting, then the time between experimental infection and taking the study drug will be increased (Cohort 2). If the study drug doesn't show enough impact on symptoms in Cohort 1, then the study will progress to Part B (Cohort 3). Part B will assess how taking the study drug prevents lung symptoms before experimental HRV infection (i.e. prophylactic treatment).
This study will also assess the safety of the study drug, levels of study drug in the blood and biomarkers of HRV infection.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0083
Date of REC Opinion
16 May 2022
REC opinion
Further Information Favourable Opinion