Conditions: COPD Exacerbation
Keywords: COPD Exacerbation Etanercept TNF alpha Randomized
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 81
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether treatment with antibiotics plus a TNFalpha antagonist will provide more effective treatment for acute COPD exacerbation compared to the current standard treatment of antibiotics plus prednisone.

Detailed description:
Acute exacerbations of COPD (AECOPD)are usually treated with steroids and antibiotics. Currently this conventional therapy has significant side effects including osteoporosis, cataracts,and suppression of the immune system. Studies have suggested that up to 24% of inpatients and 27% of outpatients fail this treatment by 4 weeks. During an acute exacerbation of COPD, the inflammatory process increases. Studies have shown the TNF-alpha cytokines appears to play a major role. Etanercept is a TNF alpha inhibitor. It inactivates TNF alpha cytokines by blocking their interaction with their cellular receptors. This study will compare the treatment of acute exacerbations of COPD with: 1) Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days, or 2) Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later. Patients randomized to group 1 (the control group) will receive placebo subcutaneous injections, and patients randomized to group 2 (the experimental group) will receive placebo prednisone capsules.

Arms:
arm 1: etanercept 50 mg subcutaneous given on the day of randomization and one week later prednisone placebo po daily for 10 days Levofloxacin 750 mg po daily for 10 days. arm 2: prednisone 40 mg daily for 10 days etanercept placebo subcutaneous given on the day of randomization and one week later Levofloxacin 750 mg daily for 10 days.

Interventions: intervention 1: Prednisone intervention 2: Etanercept intervention 3: levofloxacin
Intervention descriptions: intervention 1: prednisone 40 mg daily for 10 days or placebo prednisone intervention 2: etanercept 50 mg subcutaneous given on the day of randomization and one week later or placebo subcutaneous injection intervention 3: Levofloxacin 750 mg daily for 10 days.

Protocol document: