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

A

Abgenix

Status and phase

Completed
Phase 2

Conditions

Pulmonary Disease, Chronic Obstructive
Bronchitis, Chronic

Treatments

Drug: ABX-IL8

Study type

Interventional

Funder types

Industry

Identifiers

NCT00035828
ABX-0209

Details and patient eligibility

About

To determine if ABX-IL8 will improve shortness of breath.

Full 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.

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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