Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-03-02 @ 4:24 PM
Study NCT ID:
NCT02294734
Status:
COMPLETED
Last Update Posted:
2021-08-12
First Post:
2014-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Efficacy Study of GSK2269557 Added to Standard Care in Subjects With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
A Randomised, Double-blind (Sponsor Unblinded), Placebo-controlled, Parallel-group, Multicentre Study to Evaluate the Efficacy and Safety of GSK2269557 Administered in Addition to Standard of Care in Adult Subjects Diagnosed With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Status:
COMPLETED
Status Verified Date:
2021-08
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:
The purpose of this study is to evaluate the efficacy of GSK2269557 administered in addition to standard of care in adult subjects diagnosed with an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Additionally study will also assess safety, tolerability and pharmacokinetic data. The total duration of the study will be 13-14 weeks including screening, treatment period and a follow up visit. Subjects will receive once daily study treatment administration starting on Day 1. Study is planned to recruit approximately 120 subjects such that approximately 100 subjects complete the study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2014-001972-70 | EUDRACT_NUMBER | None | View |