The Study of Soy Isoflavones in Asthma (SOYA)

December 10, 2015 updated by: Robert A. Wise, M.D., American Lung Association Asthma Clinical Research Centers
The trial is designed to study the effects of soy supplements on asthma control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Asthma is a common disease that has a major impact on morbidity and health care costs. Although the prevalence and severity of asthma have increased over the last several decades, the specific causes remain unknown. One possible mechanism is a change in diet. Yet, epidemiological and interventional studies designed to identify a key nutrient or antioxidant vitamin that may be responsible for the increase in disease severity have produced inconsistent results. A recent pilot study showed a soy isoflavone supplement reduces exhaled nitric oxide (FeNO) and ex vivo LTC4 synthesis in patients with inadequately controlled asthma. This clinical trial is designed to test the novel hypothesis that dietary supplementation with soy isoflavones is an effective treatment in patients with poorly controlled asthma. The study will include 380 patients with low dietary soy intake, 12 years of age or older, who are taking either inhaled corticosteroids or leukotriene modifiers and have inadequately controlled asthma. Participants will be randomly assigned to treatment with either a soy isoflavone supplement (containing genistein, daidzein and glycitein; 100 mg daily of the glycoside forms) or placebo for six months. The results of this trial will increase understanding of the role of diet in asthma; could identify a novel, safe and relatively inexpensive treatment for patients with asthma; and potentially will have a substantial impact on public health in the United States.

Study Type

Interventional

Enrollment (Actual)

386

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • California
      • San Diego, California, United States, 92103
        • University of California, San Diego
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Nemours Children's Clinic
      • Miami, Florida, United States, 33136
        • University of Miami School of Medicine
      • Tampa, Florida, United States, 33613
        • University of South Florida College of Medicine
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Northwestern Memorial Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State University Health Sciences Center
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • University of Missouri, Kansas City School of Medicine
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • New Hyde Park, New York, United States, 11040
        • North Shore - Long Island Jewish Health System
      • New York, New York, United States, 10016
        • New York University School of Medicine
      • Valhalla, New York, United States, 10595
        • New York Medical College
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Davis Heart and Lung Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Vermont Lung Center at the University of Vermont

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Placebo
Active Comparator: Soy Isoflavone
Oral isoflavone supplement (100 mg/day)
Drug: Soy isoflavone supplement
Oral soy isoflavone supplement (100 mg/day)
Other Names:
  • Soy supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Change From Baseline to 24 Weeks for FEV1
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Lung Association Asthma Clinical Research Centers

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Lewis J Smith, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

December 4, 2009

First Submitted That Met QC Criteria

January 19, 2010

First Posted (Estimate)

January 20, 2010

Study Record Updates

Last Update Posted (Estimate)

January 14, 2016

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALAACRC-10
  • R01HL087987-01A2 (Other Identifier: NIH/NHLBI)
  • R01 HL0088367-01A2 (Other Identifier: NIH/NHLBI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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