The Study of Soy Isoflavones in Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Soy isoflavone supplement; Placebo
Intervention description: Oral soy isoflavone supplement (100 mg/day); Placebo
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 386.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Asthma; Soy; Supplement; ACRC; SOYA

Summary:

      The trial is designed to study the effects of soy supplements on asthma control.
    

Eligibility criteria:

        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