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:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-24 @ 10:29 PM
NCT ID:
NCT04722835
Eligibility Criteria:
Inclusion Criteria:
* Ages between 40 to 75 years old.
* History of at least 20 pack-years of smoking.
* No diagnosis of COPD or asthma.
* No spirometric evidence of airflow obstruction as determined by FEV1/FVC ratio ≥0.7.
* FEV1 and FVC \>lower limit of normal.
* Less than 1 pack-year history of tobacco smoking and no tobacco use within the past 12 months.
* Subjects will be divided into two groups by their RV/TLC:
Normal RV/TLC Group:
• Plethysmographic RV/TLC equal or less than lower limit of normal.
Abnormal RV/TLC Group:
• Plethysmographic RV/TLC higher than lower limit of normal.
Exclusion Criteria:
* Any history of IV drug use or inhalation of recreational drugs other than marijuana: A- within the past 20 years. B- more than 100 times IV drug usage. C- longer than 1 year usage.
* Marijuana use \>400 joints in lifetime or any within past 6 months.
* Inability to walk briskly, run on treadmill, or pedal on ergometer to perform the study-required exercise level.
* Pregnant/breast feeding.
* Serious and active heart conditions- defined by stable or unstable angina, recent myocardial infarction (within the last 2 years), active congestive heart failure, ischemic cardiomyopathy.
* Liver cirrhosis.
* History of chronic active Hepatitis B or C.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT04722835
Study Brief:
Protocol Section:
NCT04722835