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| Sponsor: | Ottawa Hospital Research Institute |
|---|---|
| Information provided by (Responsible Party): | Ottawa Hospital Research Institute |
| ClinicalTrials.gov Identifier: | NCT00789997 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
COPD Exacerbation |
Drug: Etanercept + Levofloxacin + placebo prednisone capsules Drug: Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | TNF-alpha Antagonists for Acute Exacerbations of COPD: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial |
| Enrollment: | 81 |
| Study Start Date: | November 2008 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Etanercept |
Drug: Etanercept + Levofloxacin + placebo prednisone capsules
Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
|
| Active Comparator: Prednisone |
Drug: Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections
Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
|
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.
Eligibility| Ages Eligible for Study: | 35 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Both inpatients and outpatients with acute COPD exacerbation will be selected for randomization. Patients will be considered to fulfill the diagnosis of AECOPD if they meet the following 5 criteria:
Patients must be experiencing an acute exacerbation of COPD and must meet at least two of the following three clinical criteria for acute COPD exacerbation as defined by Anthonisen:
The above complaints had to have necessitated the emergency department or physician visit.
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Ottawa Hospital Research Institute |
| ClinicalTrials.gov Identifier: | NCT00789997 History of Changes |
| Other Study ID Numbers: | 2007791-01H |
| Study First Received: | November 12, 2008 |
| Last Updated: | October 20, 2011 |
| Health Authority: | Canada: Health Canada; Canada: Ethics Review Committee |
|
COPD Exacerbation Etanercept TNF alpha Randomized |
|
Lung Diseases Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Ofloxacin Prednisone TNFR-Fc fusion protein Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary |
Renal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Antirheumatic Agents Gastrointestinal Agents |