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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00035828
Enrollment
150
Registered
2002-05-07
Start date
2001-12-31
Completion date
2002-12-31
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchitis, Chronic, Pulmonary Disease, Chronic Obstructive

Keywords

COPD, Chronic bronchitis, Chronic obstructive pulmonary disease, Shortness of breath, Dyspnea, Bronchitis

Brief summary

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

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.

Interventions

DRUGABX-IL8

Sponsors

Abgenix
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026