Ignite Creation Date:
2024-05-06 @ 9:37 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03034967
Status:
COMPLETED
Last Update Posted:
2020-10-28
First Post:
2017-01-25
Brief Title:
Danirixin Dose Ranging Study in Participants With Chronic Obstructive Pulmonary Disease COPD
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Randomised Double-Blind Sponsor Open Placebo-Controlled Multicentre Dose Ranging Study to Evaluate the Efficacy and Safety of Danirixin Tablets Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Participants With Chronic Obstructive Pulmonary Disease COPD
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Danirixin DNX is a selective CXC chemokine receptor CXCR2 antagonist being developed as a potential anti-inflammatory agent for the treatment of COPD This is a Phase 2 randomized double-blind Sponsor Open study The primary objective of the study is to evaluate the clinical activity and safety of danirixin compared with placebo in participants with COPD Following baseline assessments collected over a 7 day period participants will be randomized 111111 to receive one of five dose strengths of danirixin 5 milligram mg 10 mg 25 mg 35 mg and 50 mg or placebo Study treatment will be administered orally twice daily for 24 weeks Participants will continue with their standard of care inhaled medications ie long acting bronchodilators with or without inhaled corticosteroids while receiving study treatment Follow up will continue up to 28 days post last dose Approximately 700 participants will be screened with a target of 540 participants completing 24 weeks of treatment and key study assessments
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| 2016-003675-21 | EUDRACT_NUMBER | None | None |