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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

NCT ID: NCT00035828

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2002-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pulmonary Disease, Chronic Obstructive Bronchitis, Chronic

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ABX-IL8

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abgenix

INDUSTRY

Sponsor Role lead

Locations

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Abgenix

Fremont, California, United States

Site Status

Countries

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United States

Other Identifiers

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ABX-0209

Identifier Type: -

Identifier Source: org_study_id