Back to resultsA 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
Primary Purpose
Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ABX-IL8
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD, Chronic bronchitis, Chronic obstructive pulmonary disease, Shortness of breath, Dyspnea, Bronchitis
Eligibility Criteria
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
Sites / Locations
- Abgenix
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00035828
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2003
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abgenix
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
Keywords
COPD, Chronic bronchitis, Chronic obstructive pulmonary disease, Shortness of breath, Dyspnea, Bronchitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ABX-IL8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Abgenix
City
Fremont
State/Province
California
ZIP/Postal Code
94555
Country
United States
12. IPD Sharing Statement
Learn more about this 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
We'll reach out to this number within 24 hrs