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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00035828
First Posted: May 7, 2002
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abgenix
  Purpose
To determine if ABX-IL8 will improve shortness of breath.

Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive Bronchitis, Chronic Drug: ABX-IL8 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00035828


Locations
United States, California
Abgenix
Fremont, California, United States, 94555
Sponsors and Collaborators
Abgenix
  More Information

ClinicalTrials.gov Identifier: NCT00035828     History of Changes
Other Study ID Numbers: ABX-0209
First Submitted: May 6, 2002
First Posted: May 7, 2002
Last Update Posted: December 9, 2005
Last Verified: July 2003

Keywords provided by Abgenix:
COPD
Chronic bronchitis
Chronic obstructive pulmonary disease
Shortness of breath
Dyspnea
Bronchitis

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Bronchitis
Acute Disease
Bronchitis, Chronic
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Infections