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 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT00363805
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of chronic obstructive pulmonary disease
* FEV\_1/FVC ≤ 78
* History of smoking ≥ 1 pack daily for 30 years OR 2 packs daily for 15 years
* Stopped smoking for ≥ 1 year
* No previously diagnosed bronchiectasis
* No history of \> 1 acute emphysema exacerbation within the past 3 months
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* WBC ≥ 3,500/mm³
* Platelet count \> 130,000/mm³
* Hemoglobin ≥ 11 g/dL (female) or 12 g/dL (male)
* AST and ALT normal
* Bilirubin ≤ 1.5 mg/dL (unless Gilbert's disease present)
* Creatinine ≤ 1.5 mg/dL
* Alkaline phosphatase ≤ 2 times upper limit of normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No invasive cancer within the past 5 years
* Able and willing to consume caffeinated beverages
* Able to produce induced sputum
* Able to perform forced expiratory maneuver during spirometry testing
* No immunosuppression by virtue of medication or disease including, but no limited to, any of the following:
* Organ transplantation
* Liver or kidney failure
* Autoimmune diseases
* Oral steroids
* Chemotherapy
* No serious concurrent illness that could preclude study compliance, such as uncontrolled high blood pressure, heart disease, or poorly controlled diabetes
* No myocardial infarction within the past 6 weeks
PRIOR CONCURRENT THERAPY:
* At least 2 weeks since prior and no concurrent dietary supplements or herbal products, including any of the following:
* Herbal tea
* Ginkgo biloba \> 60 mg/day
* Melatonin \> 3 mg/day
* Echinacea \> 300 mg/day
* Hypericum perforatum (St. John's wort) \> 300 mg/day
* DHEA mustard \> 5 mg/day
* At least 2 weeks since prior and no concurrent nontrial tea or tea products
* More than 3 weeks since prior chest or abdominal surgery
* More than 3 months since prior participation in chemoprevention or clinical intervention trials
* At least 3 months since prior and no concurrent megadoses of vitamins, defined as \> 4,000 IU of vitamin A, 400 IU of vitamin E, 400 IU of cholecalciferol (vitamin D), 60 μg of selenium, or 1,000 mg of ascorbic acid (vitamin C) per day
* No regular consumption of ≥ 6 cups or glasses of tea per week
* No concurrent nontrial caffeine at \> 1 serving/day (1 serving defined as 12 oz of regular soda or 8 oz of coffee)
* No concurrent participation in another interventional clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT00363805
Study Brief:
Protocol Section:
NCT00363805