A study evaluating the effect of danirixin on NETs in COPD
Research type
Research Study
Full title
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)
IRAS ID
231691
Contact name
James Chalmers
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd
Eudract number
2017-001069-25
Duration of Study in the UK
0 years, 8 months, 0 days
Research summary
The aim of this GlaxoSmithKline (GSK) sponsored study, is to better understand how a new drug called danirixin works in patients with chronic obstructive pulmonary disease (COPD). COPD affects the lungs, whereby inflammation causes destruction of lung tissue and obstruction of the airways, resulting in symptoms such as cough, breathlessness and phlegm production.
Neutrophils are a type of white blood cell that usually protect the body by attacking bacteria and viruses (“pathogens”). One way in which they attack pathogens is through the production of neutrophil extracellular traps (NETs), which are structures that are capable of trapping and killing pathogens. When neutrophils produce too many NETs, these traps may attack parts of the body instead, such as the lung. There is evidence to suggest that some people with COPD have increased levels of NETs, and in these people, this could be one reason why their COPD gets worse.
Danirixin is an anti-inflammatory drug, not yet approved for doctors to prescribe. It is thought that drugs such as danirixin that block a “receptor” (or site) known as CXCR2 can reduce NETs production, thereby reducing or slowing potential further damage to the lungs of people with COPD.
This study will compare danirixin and placebo (a dummy medicine) in participants with COPD. Participants will receive either danirixin or placebo as a tablet given twice daily for 14 days; the chances of receiving danirixin will be 3 times higher than receiving placebo. The treatment groups will be selected randomly by a computer.
Participants will attend a maximum of 5 visits over a period of up to 2 months where various blood and lung tests will be carried out. There will be a screening/baseline period of up to 30 days, a 2-week treatment period, and a follow-up phone call 1 week later.
REC name
Scotland A: Adults with Incapacity only
REC reference
17/SS/0111
Date of REC Opinion
29 Sep 2017
REC opinion
Further Information Favourable Opinion