At a glance
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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
In Brief
A Phase 2 clinical trial evaluating GSK2245035 Nasal Spray Solution and Placebo Nasal Spray Solution for Asthma. Completed, enrolled 36 participants across 6 sites in 2 countries.
Detailed Summary
This study will assess whether Toll like receptor 7 (TLR7)-mediated pharmacology, with intranasal (i.n.) GSK2245035 20 nanogram (ng) administered weekly for a period of 8 weeks, will lead to reduced allergic reactivity in the lower airways in subjects with mild allergic asthma. This will be a randomised, double-blind (sponsor open), placebo-controlled, parallel group, 8-week treatment study. The study will consist of a screening period of up to approximately 4 weeks (involving two screening visits), a blinded treatment period of 8 weeks, followed by a follow-up period of up to 3 months. The total duration of the study for each subject will therefore be a maximum of approximately 6 months.
Study Details
Timeline
Interventions
GSK2245035 Nasal Spray Solution 0.2 microgram (mcg)/mL delivering 10 ng GSK2245035 per actuation. A solution formulation in saline, preserved with Benzalkonium Chloride and Disodium Edetate.
Nasal Spray Solution as for GSK2245035 without active ingredient.