Ignite Creation Date:
2024-05-06 @ 10:26 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03250689
Status:
TERMINATED
Last Update Posted:
2021-03-29
First Post:
2017-08-11
Brief Title:
Randomized Study Evaluating the Effect of Danirixin on Neutrophil Extracellular Traps NETs in Chronic Obstructive Pulmonary Disease COPD
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official 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
Status:
TERMINATED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated due to a change in the benefit-risk profile for danirixin in COPD
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 31 to receive danirixin hydrobromide HBr 35 milligram mg orally twice daily or matching placebo for 14 days Subjects may continue to use rescue medications and inhaled COPD maintenance medications 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-001069-25 | EUDRACT_NUMBER | None | None |