The Study of Soy Isoflavones in Asthma

Exclusion Criteria

• •Pulmonary function
• •* FEV1 less than 50% predicted pre-bronchodilator
• •Other major chronic illnesses
• •* Conditions which in the judgment of the study physician would interfere with participation in the study, e.g., non-skin cancer, endocrine disease, coronary artery disease, severe hypertension, immunodeficiency states
• •* History of thyroid disease, breast cancer, ovarian, or endometrial cancer
• •* History of physician diagnosis of chronic bronchitis, emphysema, or COPD
• •Medication use
• •* Current consumption of soy isoflavone supplements
• •* Oral corticosteroid use within the past 6 weeks
• •* Use of tamoxifen
• •Use of an investigational treatment in the previous 30 days
• •"Drug" allergy
• •* Known adverse reaction to genistein, other phytoestrogens, or soy products
• •Females of childbearing potential
• •* Pregnant or lactating. Participants must agree to use effective contraception during the trial.
• •Non-adherence
• •* Inability or unwillingness to provide consent or, in the case of children, inability or unwillingness of the child to provide assent
• •* Inability to swallow study medication
• •* Inability to perform baseline measurements
• •* Completion of less than 10 of the last 14 days diary entries during screening period
• •* Inability to be contacted by telephone
• •* Intention to move out of the area within 6 months
• •Other
• •* Recent asthma exacerbation (within 6 weeks)
• •* Recent upper respiratory infection (within 2 weeks)
• •* Body weight less than 77 pounds (35 kg)
• •* Intake of soy or soy-enriched foods 1 or more times a week
• •* Change in diet over the past month or expected change in diet during the study