Status:
COMPLETED
Biomarkers and Genetic Factors Related to Emphysema
Lead Sponsor:
Washington University School of Medicine
Conditions:
Emphysema
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
45+ years
Brief Summary
Emphysema, a common type of chronic obstructive pulmonary disease (COPD), is a long-term lung disease that is usually caused by cigarette smoking. This study will examine both current smokers and form...
Detailed Description
COPD is a disease in which the lung is damaged and breathing passages become partly obstructed, making it difficult to breathe. Millions of people in the United States have COPD, and it is the fourth ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for All Participants:
- Able to read and write English
- At least 30 pack-year smoking history (the equivalent of smoking a pack a day for 30 years)
- Able to participate in the informed consent process
- Relatively stable clinical status for the past six weeks (i.e., no illness in the 6 weeks before study entry)
- Inclusion Criteria for Participants with Emphysema:
- Global Initiative for Chronic Obstructive Lung Disease (GOLD) class II, III, or IV COPD, as determined by post-bronchodilator spirometry values OR
- More than minimal emphysema on an acceptable-quality chest CT scan
- Inclusion Criteria for Participants without Emphysema:
- GOLD class I COPD or GOLD class 0 (2005 classification), as determined post-bronchodilator spirometry values AND
- No or minimal emphysema on an acceptable-quality chest CT scan
- Exclusion Criteria:
- Pregnant
- Prisoner
- Vulnerable populations
- Recent illness (defined as increased cough, sputum production, worsening malaise, or need for unscheduled physician visit in the 6 weeks prior to enrollment)
- Coexisting active chronic inflammatory or collagen vascular disease, immunodeficiency of any kind, non-cutaneous malignancy (melanoma is an exclusion), or previous organ transplant
- Congenital abnormalities of the lung or previous lung surgery
- Known active hepatitis B, hepatitis C, or HIV/AIDS (not prospectively evaluated)
- CT evidence of lung disease other than emphysema (including significant fibrosis, bronchiectasis, consolidation, or indeterminate nodules)
Exclusion
Key Trial Info
Start Date :
October 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT00757120
Start Date
October 1 2007
End Date
September 1 2011
Last Update
May 4 2018
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110