The Study of Soy Isoflavones in Asthma

Completed · Phase 4 · Has a placebo group

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT01052116

Run by

American Lung Association Asthma Clinical Research Centers

People needed

386

Starts

2010-03-01

Expected to finish

2012-08-01

Last updated by the study team

2016-01-14

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of Arizona — Tucson, Arizona, United States
• University of California, San Diego — San Diego, California, United States
• National Jewish Health — Denver, Colorado, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• University of Miami School of Medicine — Miami, Florida, United States
• University of South Florida College of Medicine — Tampa, Florida, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Louisiana State University Health Sciences Center — New Orleans, Louisiana, United States
• University of Missouri, Kansas City School of Medicine — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• North Shore - Long Island Jewish Health System — New Hyde Park, New York, United States
• New York University School of Medicine — New York, New York, United States
• New York Medical College — Valhalla, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Davis Heart and Lung Research Institute — Columbus, Ohio, United States
• Baylor College of Medicine — Houston, Texas, United States
• Vermont Lung Center at the University of Vermont — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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