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

Chronic Obstructive Pulmonary Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056264
• Other study ID #: CR004795
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2003
• Last updated: May 16, 2011
• Start date: December 2002
• Est. completion date: December 2004

Study information

• Verified date: April 2010
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Infliximab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor, Inc.

References & Publications (1)

Rennard SI, Fogarty C, Kelsen S, Long W, Ramsdell J, Allison J, Mahler D, Saadeh C, Siler T, Snell P, Korenblat P, Smith W, Kaye M, Mandel M, Andrews C, Prabhu R, Donohue JF, Watt R, Lo KH, Schlenker-Herceg R, Barnathan ES, Murray J; COPD Investigators. T — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Chronic Respiratory Questionnaire (CRQ) total score at week 24
Secondary	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

External Links

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