Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT00757120
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT00757120
Study Brief:
Protocol Section:
NCT00757120