ABX-IL8 in Pulmonary Disease, Chronic Obstructive and Bronchitis, Chronic - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: ABX-IL8

Detailed Description

Chronic Obstructive Pulmonary Disease (COPD) is defined as a disease state characterized by the presence of airflow obstruction due to chronic bronchitis or emphysema. The airflow obstruction is generally progressive, may be accompanied by airway hyper-reactivity, and may be partially reversible. Inflammation in the lungs is triggered by exposure to inhaled toxic substances that can lead to tissue damage, mucous secretion, airways narrowing and tissue destruction.

Interleukin-8 (IL-8) plays a major role in elevating sputum in patients with COPD and may contribute to tissue destruction. Therefore, the highly specific antibody to IL-8 (such as ABX-IL8) may help to reduce mucous production and tissue destruction.

Study Type

Interventional

Enrollment

150

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Fremont, California, United States, 94555
    - Abgenix

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

> 50 years old
> 20 pack-year of smoking
Diagnosed with COPD and chronic bronchitis

Exclusion Criteria:

Patients with bronchiectasis, cystic fibrosis, tuberculosis, asthma, alpha-1 antitrypsin deficiency, CHF
Require oxygen therapy
Uncontrolled hypertension
HIV or Hepatitis
Recent history of COPD exacerbation
Patients with cancer
Recent history of infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abgenix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Study Completion

December 1, 2002

Study Registration Dates

First Submitted

May 6, 2002

First Submitted That Met QC Criteria