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Sponsored by: |
Centocor, Inc. |
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Information provided by: | Centocor, Inc. |
ClinicalTrials.gov Identifier: | NCT00056264 |
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 body's immune system to help control the development of inflammation to help reduce painful disease.
Condition | Intervention | Phase |
---|---|---|
COPD Chronic Obstructive Pulmonary Disease |
Drug: Infliximab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 225 |
Study Start Date: | December 2002 |
Study Completion Date: | December 2004 |
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 function.The purpose of this study is to evaluate the safety and effectiveness of infliximab in the treatment of patients with symptoms of moderate to severe COPD.Patients will be receive infusions of either placebo, 3 mg/kg infliximab or 5mg/kg infliximab at weeks 0, 2, 6, 12, 18, and 24.Safety 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 mg/kg infliximab or 5mg/kg infliximab at weeks 0, 2, 6, 12, 18, and 24.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR004795 |
Study First Received: | March 7, 2003 |
Last Updated: | March 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00056264 |
Health Authority: | United States: Food and Drug Administration |
Infliximab Chronic obstructive pulmonary disease Remicade COPD |
Signs and Symptoms Lung Diseases, Obstructive Respiratory Tract Diseases Infliximab |
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |
Anti-Inflammatory Agents Therapeutic Uses Gastrointestinal Agents |
Antirheumatic Agents Dermatologic Agents Pharmacologic Actions |