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Bronchitis |
Respiratory Infection, Bronchitis |
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
This study has been completed.
|
Purpose
To determine if ABX-IL8 will improve shortness of breath.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Pulmonary Disease, Chronic Obstructive Bronchitis, Chronic | Drug: ABX-IL8 | Phase II |
MedlinePlus related topics: Bronchitis; COPD (Chronic Obstructive Pulmonary Disease)
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Expected Total Enrollment: 150
Study start: December 2001; Study completion: December 2002
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.
Eligibility
Ages Eligible for Study: 50 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
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
Location Information
California
Abgenix, Fremont, California, 94555, United States
More Information
Record last reviewed: July 2003
Last Updated: October 13, 2004
Record first received: May 6, 2002
ClinicalTrials.gov Identifier: NCT00035828
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Acute Bronchitis (American Academy of Family Physicians)
- Acute Bronchitis (American Academy of Family Physicians)
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