Effects of Infliximab (Remicade) on Fat Free Mass in Patients With Moderate to Severe COPD Suffering From Cachexia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- Fat-free mass
- Major Secondary Efficacy Endpoints in order of importance:
- a. Change in body weight at 8 weeks
- b. Change from baseline in functional capacity assessed by the incremental shuttle walk test (ISWT) at 8 weeks
- c. Change from baseline in muscle strength (quadriceps, sniff nasal pressure, hand grip strength) at 8 weeks
- d. Change from baseline in St George’s Respiratory Disease Questionnaire (SGRQ) at 8 weeks
- Other Secondary Efficacy Endpoints:
- change from baseline at 8 weeks and other timepoints in:
- a. Fat-Free Mass (FFM) as measured by DEXA scan
- b. Body Mass Index (BMI)
- c. Spirometry (FEV1, FVC, PEF25-75)
- d. Quality of life as measured by the Short-Form 36-Item (SF-36)
- e. Transitional Dyspnoea Index (TDI)
- f. Muscle cell histology: muscle biopsy is optional
- g. Sputum inflammatory cell count: sputum induction is optional
- h. Exacerbation frequency and severity
- Other objectives of this trial are to evaluate pharmacokinetics (PK) and pharmacodynamics (PD) in the treatment of patients with COPD-related cachexia.
|Study Start Date:||October 2003|
|Estimated Study Completion Date:||December 2005|
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 mg/kg infliximab or placebo 1:1 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.
|Center for Integrated Rehabilitation and Organ failure (CIRO) Horn|
|Horn, Netherlands, 6085 NM|
|Principal Investigator:||Emiel FM Wouters, PhD, MD||University Hospital Maastricht, Department of Respiratory Medicine|