A Blinded Study Comparing the Safety and Efficacy of a Fully Human Anti-IL8 Monoclonal Antibody (ABX-IL8) to Placebo in Patients With Chronic Bronchitis and COPD

This study has been completed.

First Received: May 6, 2002 Last Updated: June 23, 2005 History of Changes

Sponsored by:	Abgenix
Information provided by:	Abgenix
ClinicalTrials.gov Identifier:	NCT00035828

Purpose

To determine if ABX-IL8 will improve shortness of breath.

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive Bronchitis, Chronic	Drug: ABX-IL8	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Breathing Problems Bronchitis COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: ABX-IL 8

U.S. FDA Resources

Further study details as provided by Abgenix:

Estimated Enrollment:	150
Study Start Date:	December 2001
Estimated Study Completion Date:	December 2002

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035828

Locations

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

Sponsors and Collaborators

Abgenix

More Information

No publications provided

Study ID Numbers:	ABX-0209
Study First Received:	May 6, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00035828 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abgenix:

COPD
Chronic bronchitis
Chronic obstructive pulmonary disease

Shortness of breath
Dyspnea
Bronchitis

Study placed in the following topic categories:

Bronchial Diseases
Respiration Disorders
Antibodies, Monoclonal
Bronchitis, Chronic
Lung Diseases, Obstructive
Antibodies
Respiratory Tract Diseases

Respiratory Tract Infections
Lung Diseases
Bronchitis
Chronic Disease
Dyspnea
Immunoglobulins
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Bronchitis, Chronic
Disease Attributes
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Infections
Respiratory Tract Diseases

Bronchial Diseases
Lung Diseases
Respiration Disorders
Chronic Disease
Bronchitis
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on July 02, 2009