NCT00035828

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2001

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2002

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 2003

First QC Date

May 6, 2002

Last Update Submit

June 23, 2005

Conditions

Pulmonary Disease, Chronic ObstructiveBronchitis, Chronic

Keywords

COPDChronic bronchitisChronic obstructive pulmonary diseaseShortness of breathDyspneaBronchitis

Interventions

ABX-IL8DRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 50 years old
  • \> 20 pack-year of smoking
  • Diagnosed with COPD and chronic bronchitis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abgenix

Fremont, California, 94555, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveBronchitis, ChronicDyspneaBronchitis

Interventions

ABX-Interleukin 8

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 6, 2002

First Posted

May 7, 2002

Study Start

December 1, 2001

Study Completion

December 1, 2002

Last Updated

June 24, 2005

Record last verified: 2003-07

Locations

US(1)