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 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT00571792
Eligibility Criteria:
Inclusion Criteria:
* Age 45-70 yrs of age, incl, women as described above as far as child-bearing potential and subjects who if they have coexisting disease, the disease is stable and does not place an untoward risk or result in compromise of data.
* Non smokers will be lifelong and have not worked in a chronic dusty environment.
* Smokers will require a minimum of 10 pkyr history and currently smoking at least a pack per day. The smokers without symptoms of COPD must demonstrate a pulmonary function with an FEV1 \> 80%. The FEV1/FVC ratio may be less than .7 however they can not demonstrate symptoms of chronic bronchitis by medical history. Smokers with symptoms must demonstrate an FEV1 \< 80% and FEV1/FVC \<.7.
Exclusion Criteria:
* Any female subject who is pregnant or breast-feeding or a female subject who is of child-bearing potential who is unwilling to sue two acceptable methods of birth control.
* Any condition that would place the subject at risk for endobronchial brushings(such as bleeding diathesis) or subjects who are currently taking anticoagulants.
* Any subject who has had an exacerbation of COPD within the last six months of screening or who has been hospitalized for any reason within the last three months.
* Illicit substances indicated by positive urine drug screen.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
70 Years
Study:
NCT00571792
Study Brief:
Protocol Section:
NCT00571792