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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

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.
 
ClinicalTrials.gov Identifier: NCT00035828
Recruitment Status : Completed
First Posted : May 7, 2002
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
Abgenix

Study Description
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Brief Summary:
To determine if ABX-IL8 will improve shortness of breath.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Bronchitis, Chronic Drug: ABX-IL8 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : December 2001
Study Completion Date : December 2002

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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
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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
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United States, California
Abgenix
Fremont, California, United States, 94555
Sponsors and Collaborators
Abgenix
More Information
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ClinicalTrials.gov Identifier: NCT00035828    
Other Study ID Numbers: ABX-0209
First Posted: May 7, 2002    Key Record Dates
Last Update Posted: June 24, 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:
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Bronchitis
Bronchitis, Chronic
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Acute Disease
Respiratory Tract Diseases
 Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Respiratory Tract Infections
Infections
Bronchial Diseases