Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00244192
Status:
COMPLETED
Last Update Posted:
2005-12-09
First Post:
2005-10-25
Brief Title:
Effects of Infliximab Remicade on Fat Free Mass in Patients With Moderate to Severe COPD Suffering From Cachexia
Sponsor:
Center for Integrated Rehabilitation and Organ Failure Horn
Organization:
Center for Integrated Rehabilitation and Organ Failure Horn
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study Evaluating the Effects of Infliximab Remicade on Fat Free Mass in Patients With Moderate to Severe COPD Suffering From Cachexia
Status:
COMPLETED
Status Verified Date:
2005-10
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:
The purpose of this study is to determine whether infliximab is effective on fat-free mass in the treatment of patients with moderate to severe COPD suffering from cachexia
Detailed Description:
COPD is a multicomponent disease characterized by abnormal inflammatory response of the lungs to noxious particles that accompanied by systemic effects like weight loss muscle wasting reduced functional capacity and health status A persistent systemic inflammatory response reflected by enhanced levels of acute phase proteins like C-reactive protein CRP or pro-inflammatory cytokines such as tumor necrosis factor TNF - α is present in COPD There are several studies that indicate that an increased systemic inflammator response is associated with weight loss cachexia loss of fat-free muscle mass physical functioning and health status
Cachexia associated with systemivc inflammation can not always readily be overcome by nutritional intervention alone
The hypothesis of this study is that infliximab therapy 3 infusions with 5 mgkg infliximab or placebo 11 on week 0 2 and 6 will increase fat-free mass relatively to placebo by decreasing inflammation Secondary endpoints are lung function muscle function exercise capacity and health status On week 8 12 and 26 follow-up measurements will be done
Cachexia associated with systemivc inflammation can not always readily be overcome by nutritional intervention alone
The hypothesis of this study is that infliximab therapy 3 infusions with 5 mgkg infliximab or placebo 11 on week 0 2 and 6 will increase fat-free mass relatively to placebo by decreasing inflammation Secondary endpoints are lung function muscle function exercise capacity and health status On week 8 12 and 26 follow-up measurements will be done
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