A study of GSK2245035 in allergic reactivity in mild asthmatics
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, parallel group, 8-week treatment study to investigate the safety, pharmacodynamics, and effect of the TLR7 agonist, GSK2245035, on the allergen-induced asthmatic response in subjects with mild allergic asthma
IRAS ID
208251
Contact name
Dave Singh
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2015-005645-31
Duration of Study in the UK
1 years, 0 months, 3 days
Research summary
GlaxoSmithKline (GSK) is developing a new medicine, GSK2245035, a drug that may cause changes in the airways that reduce allergic reactivity in subjects with respiratory allergies. In this study, GSK2245035 will be given to subjects with mild asthma. About 50 subjects in the EU (36 in the UK) will be randomly allocated in a 1:1 ratio to receive intranasal GSK2245035 (20ng) once per week or placebo (dummy drug) once per week, in the clinic. Subjects will be in the study for about 24 weeks: in screening for 4 weeks (up to 3 visits, including one for which some assessments are repeated 24 hours later) to ensure the subject is right for the study; on treatment for 8 weeks (weekly visits with some assessments repeated at 24 hours later for 3 visits), and in follow-up for 12 weeks (3 visits, with some assessments repeated 24 hours later). We will compare the effects of GSK2245035 and placebo on the early (0-2 hours) and late (4-10 hours) allergic response following bronchial/nasal allergen challenges and skin prick tests (once during screening and 3 times during the follow up). This will be assessed using lung function, and biomarkers in the blood/nasal fluids and sputum following the challenges. Subjects will record their nasal symptoms, lung function and use of asthma rescue medication in a daily diary. The safety and tolerability of GSK2245035 will be assessed at every visit by looking at adverse events, electrocardiograms, clinical laboratory values, lung function and subjects' use of asthma rescue medication. The study will also provide information on how the body handles the drug.
During the study there will be an interim look at the data to check if recruitment should be stopped or if it should continue to ensure enough subject data is collected for a meaningful analysis.
REC name
Wales REC 3
REC reference
16/WA/0213
Date of REC Opinion
14 Oct 2016
REC opinion
Further Information Favourable Opinion