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 - Full Text View

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

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

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

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

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

Study ID Numbers:	ABX-0209
Study First Received:	May 6, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00035828
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:

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

Lung Diseases
Bronchitis
Chronic Disease
Dyspnea
Pulmonary Disease, Chronic Obstructive
Immunoglobulins

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009