The Study of Soy Isoflavones in Asthma

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Lung Association Asthma Clinical Research Centers
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)

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