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

This study has been completed.
Sponsor:
Information provided by:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00056264
First received: March 7, 2003
Last updated: May 16, 2011
Last verified: April 2010
  Purpose

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
COPD
Drug: Infliximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056264

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00056264     History of Changes
Other Study ID Numbers: CR004795
Study First Received: March 7, 2003
Last Updated: May 16, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Infliximab
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014