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NCT00035828 Clinical Trial

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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00035828
Other study ID # ABX-0209
Secondary ID
Status Completed
Phase Phase 2
First received May 6, 2002
Last updated June 23, 2005
Start date December 2001
Est. completion date December 2002

Study information
Verified date July 2003
Source Abgenix
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date December 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ABX-IL8

Locations
Country Name City State
United States Abgenix Fremont California

Sponsors (1)
Lead Sponsor Collaborator
Abgenix

Country where clinical trial is conducted

United States, 

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