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A Safety and Efficacy Study of Intranasal GSK2245035 in Adults With Allergic Asthma

Asthma Clinical Trial

Official title:
A Multicentre, Randomised, Placebo-controlled, Double-blind (Sponsor Open), Parallel-group, 8-week Treatment Study Investigating the Efficacy and Safety of Intra-nasal GSK2245035 in Adults With Allergic Asthma Treated With Inhaled Corticosteroids (ICS)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03707678
Study type Interventional
Source GlaxoSmithKline
Contact
Status Withdrawn
Phase Phase 2
Start date January 21, 2019
Completion date December 23, 2019
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