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 - Tabular View

Tracking Information
First Received Date ^ICMJE	May 6, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	December 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00035828 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE
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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Pulmonary Disease, Chronic Obstructive Bronchitis, Chronic
Intervention ^ICMJE	Drug: ABX-IL8
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	150
Completion Date	December 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00035828
Responsible Party
Study ID Numbers ^ICMJE	ABX-0209
Study Sponsor ^ICMJE	Abgenix
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Abgenix
Verification Date	July 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP