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

May 6, 2002
June 23, 2005
December 2001
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Complete list of historical versions of study NCT00035828 on ClinicalTrials.gov Archive Site
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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
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To determine if ABX-IL8 will improve shortness of breath.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Pulmonary Disease, Chronic Obstructive
  • Bronchitis, Chronic
Drug: ABX-IL8
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
December 2002
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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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00035828
ABX-0209
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Abgenix
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Abgenix
July 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP