Status:
COMPLETED
Comparing Two Pneumococcal Vaccines in Adults With Chronic Obstructive Pulmonary Disease
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
Pneumococcal disease is a serious bacterial infection that can affect different parts of the body, including the lungs. People with chronic illnesses, such as chronic obstructive pulmonary disease (CO...
Detailed Description
Individuals who are infected with the Streptococcus pneumoniae bacteria may develop pneumococcal disease, a serious disease that kills more people in the United States than all other vaccine-preventab...
Eligibility Criteria
Inclusion
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- Post-bronchodilator forced expiratory volume at one second
- /forced vital capacity (FEV1/FVC) level less than 70%
- Ten or more pack-years of smoking
- Willing to make return visits to the study clinic and accept telephone contact
- Last pneumococcal vaccination occured at least 5 years prior to study entry
Exclusion
- Asthma
- Sensitivity to pneumococcal vaccine
- Known bleeding disorder, or requires long-term anticoagulation therapy
- Presence of chronic disease that may impair pneumococcal vaccine response
- Acute illness requiring antibiotics in the month prior to study entry
- Medical condition that makes survival for 24 months following study entry unlikely
- Pregnant
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT00457977
Start Date
March 1 2007
End Date
May 1 2011
Last Update
May 12 2015
Active Locations (18)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
Veteran's Administration Medical Center
Birmingham, Alabama, United States, 35294-0006
3
LA BioMed at Harbor, University of California
Los Angeles, California, United States, 90502
4
University of California San Francisco-Airway Clinical Research Center
San Francisco, California, United States, 94143