This study is designed to evaluate the effect of GSK2339345 relative to placebo on the number
of coughs in patients with Chronic Idiopathic Cough (CIC) administered by an Aqueous Droplet
Inhaler (ADI). The primary aim is to investigate the efficacy of GSK2339345 on reducing
objective cough frequency in CIC patients. The secondary aim of this study is to investigate
the efficacy of GSK2339345 in inhibiting a hypertussive cough response elicited by capsaicin
and citric acid in CIC patients which have a hyperresponsive cough reflex.
Following the screening visit, all eligible subjects will attend the unit for dosing at
Visits 1-7. At Visits 1, 2 and 3 (Part A of the study), subjects will receive two doses of
either GSK2339345 or placebo, 4 hours apart and will undergo 8 hours of cough monitoring. At
Visits 4 and 5 (Part B of the study) and Visits 6 and 7 (Part C of the study), subjects will
be administered a single dose of either GSK2339345 or placebo. Subjects will then undergo
capsaicin (Part B) or citric acid (Part C) tussive challenge and will undergo cough
monitoring for 1 hour post dose.
The maximum study duration will be approximately 11 weeks, including 3 weeks screening and 2
weeks follow-up. Approximately 30 patients will be randomised into the study, such that
approximately 24 patients complete dosing and critical assessments.