A Safety and Efficacy Study of Intranasal GSK2245035 in Adults With Allergic Asthma
Status:
Withdrawn
Trial end date:
2019-12-23
Target enrollment:
Participant gender:
Summary
GSK2245035 belongs to a novel class of agonist drugs targeted at toll like receptors (TLR).
T-helper cell 2 (Th2) driven inflammation is a key patho-physiological mechanism in allergic
asthma. The clinical manifestations and inflammatory pathways of allergic asthma are
sensitive to corticosteroid therapy. However, GSK2245035 reduces Th2-driven airway
inflammation and thereby controls asthma symptoms. This study aims to determine whether
intranasal GSK2245035 maintains biological and clinical control of allergic asthma using
'tapering of ICS' study design. This study will assess the efficacy and safety of GSK2245035
in subjects with allergic asthma treated with ICS. This will be a randomised, double-blind
(sponsor open), placebo-controlled, parallel group, 8-week study treatment period. The study
will consist of a screening period of up to approximately 5 weeks, blinded treatment period
of 8 weeks, followed by a follow-up period of 7 weeks. A total of 60 subjects will be
included in this study and duration of time for each subject will therefore be 141 days
including screening and study ICS dose adjustment period. Diskus® is a registered trademark
of GlaxoSmithKline group of companies.