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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT00741208
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older;
* Physician diagnosed asthma;
* Positive methacholine bronchoprovocation test (20% fall in FEV1 at less than 8 mg/ml) with the past 3 years;
* Smoking Status: non-smoker for 6 months or longer and a less than 10 pack-year cumulative smoking history.
Exclusion Criteria:
* Pulmonary function FEV1\< 70% predicted pre-bronchodilator;
* Other major chronic illness: conditions that in the judgement of athe principle investigator would interfere with participation in the study or history of or physician diagnosis of COPD, emphysema, or chronic bronchitis;
* Medication use: current consumption of soy isoflavone supplements or oral corticosteroid use within the past 6 months OR use of an investigational treatment within the previous 30 days;
* Drug allergy: known adverse reaction to genistein, other phytoestrogens, or soy products;
* Females of childbearing potential: pregnant or lactating or women of appropriate ago who report the possibility of pregnancy at the time of enrollment will be screened and cannot participate if pregnant;
* Non-adherence: inability or unwillingness to provide informed consent or inability to swallow study medication or inability to perform baseline measurements or completion of fewer than 5 of the 7 days of screening period diary entry or inability to be contacted by telephone;
* Other exclusions: recent asthma exacerbation (within 6 weeks) or recent upper respiratory tract infection (within 2 weeks) or change in diet over the past 1 month or expected change in diet (for example a weight loss diet) during the 6 week study period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00741208
Study Brief:
Protocol Section:
NCT00741208