Dataset from Randomized Double Blind (Sponsor Unblind) Study Evaluating the Effect of 14 Days of Treatment With Danirixin (GSK1325756) on Neutrophil Extracellular Traps (NETs) Formation in Participants With Stable Chronic Obstructive Pulmonary Disease (COPD)

The inflammation associated with COPD is characterized by a prominent infiltration of
neutrophils in lung tissue and airways. The CXC chemokine receptor type 2 (CXCR2) plays a
pivotal role in neutrophil recruitment to the lungs resulting in progressive fibrosis, airway
stenosis, and destruction of the lung parenchyma characteristic of COPD. There is a paucity
of novel therapies that target these symptoms, and there are no currently available therapies
that modify disease progression in COPD. Danirixin (GSK1325756) is a selective CXCR2
antagonist being developed as a potential anti-inflammatory agent for the treatment of COPD
and influenza. This study is a mechanistic study which aims to evaluate the effect of
danirixin in reducing neutrophil extracellular traps (NETs) formation (or NETosis). Subjects
will be randomized (3:1) to receive danirixin hydrobromide (HBr) 35 milligram (mg) orally
twice daily or matching placebo for 14 days. Subjects may continue to use rescue
medication(s) and inhaled COPD maintenance medication(s) during the study. The study will
consist of a screening period of up to 30 days, a 2 week treatment period, and a 1-week
follow-up visit via phone call. Approximately 50 subjects will be screened to obtain
approximately 24 subjects to complete the study.