Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056264
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2003-03-07
Brief Title:
A Study of Safety and Efficacy of Infliximab Remicade in Patients With COPD
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Phase II Multicenter Randomized Double-Blind Placebo-Controlled Parallel Group Dose Finding Study Evaluating the Safety and Efficacy of Infliximab Administration in Symptomatic Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease COPD
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 safety and effectiveness of infliximab Remicade in patients with Chronic Obstructive Pulmonary Disease COPD Infliximab Remicade targets specific proteins in the bodys immune system to help control the development of inflammation to help reduce painful disease
Detailed Description:
Chronic Obstructive Pulmonary Disease COPD is a smoking-related inflammatory lung disease that results in reduced lung function causing the symptoms or problems that you have when breathing COPD includes both chronic bronchitis and emphysema The symptoms of COPD are cough sputum phlegm production breathlessness and wheezing Advanced disease may also involve changes in appetite and weight loss The drug used in this study is called Remicadeâ and the active component is called infliximab Infliximab binds to and blocks the activity of a naturally occurring substance in the body called tumor necrosis factor alpha or TNFa which may be associated with inflammation and a decrease in lung functionThe purpose of this study is to evaluate the safety and effectiveness of infliximab in the treatment of patients with symptoms of moderate to severe COPDPatients will be receive infusions of either placebo 3 mgkg infliximab or 5mgkg infliximab at weeks 0 2 6 12 18 and 24Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests vital signs such as blood pressure physical examinations and the occurrence and severity of adverse events as well as other study specific procedures Patients will receive infusions of either placebo 3 mgkg infliximab or 5mgkg infliximab at weeks 0 2 6 12 18 and 24
Study Oversight
Has Oversight DMC:
None
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?:
None