The Study of Soy Isoflavones in Asthma (SOYA)

This is an interventional treatment trial for Asthma focused on measuring Asthma, Soy, Supplement, ACRC, SOYA Read More

Inclusion Criteria:

• Age 12 or older

• Physician diagnosed asthma

  • FEV1 equal or greater than 50% predicted pre-bronchodilator
  • At least 12% increase in FEV1 15-3 minutes after inhaling 2-4 puffs of albuterol or positive methacholine challenge (20% fall in FEV1 at less than 8 mg/mL). Either of these can be available from the previous 2 years
  • Currently prescribed daily controller asthma medication

• Poor asthma control (at least one of the following)

  • A score of 1.5 or greater on the Juniper Asthma Control Questionnaire
  • Use of beta-agonist for asthma symptoms two or more times per week
  • Nocturnal awakening with asthma symptoms more than once per week
  • Two or more episodes of asthma symptoms in the past 12 months with each requiring at least one of the following: emergency department visit, unscheduled physician visit, prednisone course, hospitalization

• Smoking status

  • Non-smoker for 6 months or longer
  • Less than 10 pack-years smoking history

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