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

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