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A Study of Safety and Efficacy of Infliximab (Remicade) in Patients With COPD

This study has been completed.
Information provided by:
Centocor, Inc. Identifier:
First received: March 7, 2003
Last updated: May 16, 2011
Last verified: April 2010
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
Chronic Obstructive Pulmonary Disease
Drug: Infliximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • Change from baseline in Chronic Respiratory Questionnaire (CRQ) total score at week 24

Secondary Outcome Measures:
  • Change in pre-bronchodilator predicted forced expiratory volume in 1 second (FEV1) at week 24 , in 6-minute walk distance at week 24, in health survey (SF-36) physical component summary score at week 24, in Transition Dyspnea Index (TDI) score at week 24

Enrollment: 234
Study Start Date: December 2002
Study Completion Date: December 2004
Detailed Description:
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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients must have moderate or severe COPD
  • Patients must have at least one episode of COPD-related symptoms (eg, cough, sputum production, shortness of breath) within 2 months prior to screening Exclusion Criteria:
  • Patients must not have asthma as main component of obstructive airway disease
  • Patients must not have had a moderate or severe exacerbation of COPD within previous 1 month
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Please refer to this study by its identifier: NCT00056264

Sponsors and Collaborators
Centocor, Inc.
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00056264     History of Changes
Other Study ID Numbers: CR004795
Study First Received: March 7, 2003
Last Updated: May 16, 2011

Keywords provided by Centocor, Inc.:
Chronic obstructive pulmonary disease

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents processed this record on May 23, 2017