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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:
Information provided by:
Abgenix
ClinicalTrials.gov Identifier:
NCT00035828
First received: May 6, 2002
Last updated: June 23, 2005
Last verified: July 2003
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

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

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

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

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

ClinicalTrials.gov processed this record on May 16, 2013