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 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT02183818
Eligibility Criteria:
Healthy nonsmokers (n=50)
Inclusion criteria
* Must be enrolled into IRB approved protocol #1204012331(all inclusion criteria from protocol #1204012331 thus applies to this protocol)
* Self-reported never-smokers, with current smoking status validated by the absence of nicotine metabolites in urine (nicotine less than 2 ng/ml and cotinine less than 5 ng/ml)
* Negative HIV serology
Smokers with COPD (n=50)
Inclusion criteria
* Must be enrolled into IRB approved protocol #1204012331(all inclusion criteria from protocol #1204012331 thus applies to this protocol)
* Self-reported current daily smokers with greater than or equal to 10 pack-yr, validated by any of the following: urine nicotine greater than 30 ng/ml or urine cotinine greater than 50 ng/ml
* Meeting GOLD stages I-III criteria for chronic obstructive lung disease (COPD) based on postbronchodilator spirometry
* Taking any or no pulmonary-related medication, including beta-agonists, anticholinergics, or inhaled corticosteroids
* Negative HIV serology
Healthy nonsmokers (n=50)
Exclusion criteria
* Unable to meet the inclusion criteria (all exclusion criteria from protocol #1204012331 applies to this protocol)
* Evidence of malignancy within the past 5 years
Smokers with COPD (n=50)
Exclusion criteria
* Unable to meet the inclusion criteria (all exclusion criteria from protocol #1204012331 applies to this protocol)
* Individuals in whom participation in the study would compromise the normal care and expected progression of their disease
* Evidence of malignancy within the past 5 years
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT02183818
Study Brief:
Protocol Section:
NCT02183818